Psychosocial interventions for preventing and treating depression in dialysis patients

Patrizia Natale; Suetonia C Palmer; Marinella Ruospo; Valeria M Saglimbene; Kannaiyan S Rabindranath; Giovanni FM Strippoli

doi:10.1002/14651858.CD004542.pub3

. 2019 Dec 2;2019(12):CD004542. doi: 10.1002/14651858.CD004542.pub3

Psychosocial interventions for preventing and treating depression in dialysis patients

Patrizia Natale ^1,², Suetonia C Palmer ³, Marinella Ruospo ^1,², Valeria M Saglimbene ^1,², Kannaiyan S Rabindranath ^4,^✉, Giovanni FM Strippoli ^1,^2,⁵

Editor: Cochrane Kidney and Transplant Group

PMCID: PMC6886341 PMID: 31789430

Abstract

Background

People with end‐stage kidney disease (ESKD) treated with dialysis are frequently affected by major depression. Dialysis patients have prioritised depression as a critically important clinical outcome in nephrology trials. Psychological and social support are potential treatments for depression, although a Cochrane review in 2005 identified zero eligible studies. This is an update of the Cochrane review first published in 2005.

Objectives

To assess the effect of using psychosocial interventions versus usual care or a second psychosocial intervention for preventing and treating depression in patients with ESKD treated with dialysis.

Search methods

We searched Cochrane Kidney and Transplant's Register of Studies up to 21 June 2019 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.

Selection criteria

We included randomised controlled trials (RCTs) and quasi‐RCTs of psychosocial interventions for prevention and treatment of depression among adults treated with long‐term dialysis. We assessed effects of interventions on changes in mental state (depression, anxiety, cognition), suicide, health‐related quality of life (HRQoL), withdrawal from dialysis treatment, withdrawal from intervention, death (any cause), hospitalisation and adverse events.

Data collection and analysis

Two authors independently selected studies for inclusion and extracted study data. We applied the Cochrane 'Risk of Bias' tool and used the GRADE process to assess evidence certainty. We estimated treatment effects using random‐effects meta‐analysis. Results for continuous outcomes were expressed as a mean difference (MD) or as a standardised mean difference (SMD) when investigators used different scales. Dichotomous outcomes were expressed as risk ratios. All estimates were reported together with 95% confidence intervals (CI).

Main results

We included 33 studies enrolling 2056 participants. Twenty‐six new studies were added to this 2019 update. Seven studies originally excluded from the 2005 review were included as they met the updated review eligibility criteria, which have been expanded to include RCTs in which participants did not meet criteria for depression as an inclusion criterion.

Psychosocial interventions included acupressure, cognitive‐behavioural therapy, counselling, education, exercise, meditation, motivational interviewing, relaxation techniques, social activity, spiritual practices, support groups, telephone support, visualisation, and voice‐recording of a psychological intervention.

The duration of study follow‐up ranged between three weeks and one year. Studies included between nine and 235 participants. The mean study age ranged between 36.1 and 73.9 years.

Random sequence generation and allocation concealment were at low risk of bias in eight and one studies respectively. One study reported low risk methods for blinding of participants and investigators, and outcome assessment was blinded in seven studies. Twelve studies were at low risk of attrition bias, eight studies were at low risk of selective reporting bias, and 21 studies were at low risk of other potential sources of bias.

Cognitive behavioural therapy probably improves depressive symptoms measured using the Beck Depression Inventory (4 studies, 230 participants: MD ‐6.10, 95% CI ‐8.63 to ‐3.57), based on moderate certainty evidence. Cognitive behavioural therapy compared to usual care probably improves HRQoL measured either with the Kidney Disease Quality of Life Instrument Short Form or the Quality of Life Scale, with a 0.5 standardised mean difference representing a moderate effect size (4 studies, 230 participants: SMD 0.51, 95% CI 0.19 to 0.83) , based on moderate certainty evidence. Cognitive behavioural therapy may reduce major depression symptoms (one study) and anxiety, and increase self‐efficacy (one study). Cognitive behavioural therapy studies did not report hospitalisation.

We found low‐certainty evidence that counselling may slightly reduce depressive symptoms measured with the Beck Depression Inventory (3 studies, 99 participants: MD ‐3.84, 95% CI ‐6.14 to ‐1.53) compared to usual care. Counselling reported no difference in HRQoL (one study). Counselling studies did not measure risk of major depression, suicide, or hospitalisation.

Exercise may reduce or prevent major depression (3 studies, 108 participants: RR 0.47, 95% CI 0.27 to 0.81), depression of any severity (3 studies, 108 participants: RR 0.69, 95% CI 0.54 to 0.87) and improve HRQoL measured with Quality of Life Index score (2 studies, 64 participants: MD 3.06, 95% CI 2.29 to 3.83) compared to usual care with low certainty. With moderate certainty, exercise probably improves depression symptoms measured with the Beck Depression Inventory (3 studies, 108 participants: MD ‐7.61, 95% CI ‐9.59 to ‐5.63). Exercise may reduce anxiety (one study). No exercise studies measured suicide risk or withdrawal from dialysis.

We found moderate‐certainty evidence that relaxation techniques probably reduce depressive symptoms measured with the Beck Depression Inventory (2 studies, 122 participants: MD ‐5.77, 95% CI ‐8.76 to ‐2.78). Relaxation techniques reported no difference in HRQoL (one study). Relaxation studies did not measure risk of major depression or suicide.

Spiritual practices have uncertain effects on depressive symptoms measured either with the Beck Depression Inventory or the Brief Symptom Inventory (2 studies, 116 participants: SMD ‐1.00, 95% CI ‐3.52 to 1.53; very low certainty evidence). No differences between spiritual practices and usual care were reported on anxiety (one study), and HRQoL (one study). No study of spiritual practices evaluated effects on suicide risk, withdrawal from dialysis or hospitalisation.

There were few or no data on acupressure, telephone support, meditation and adverse events related to psychosocial interventions.

Authors' conclusions

Cognitive behavioural therapy, exercise or relaxation techniques probably reduce depressive symptoms (moderate‐certainty evidence) for adults with ESKD treated with dialysis. Cognitive behavioural therapy probably increases health‐related quality of life. Evidence for spiritual practices, acupressure, telephone support, and meditation is of low certainty . Similarly, evidence for effects of psychosocial interventions on suicide risk, major depression, hospitalisation, withdrawal from dialysis, and adverse events is of low or very low certainty.

Plain language summary

Are psychosocial interventions effective for treating depression among people on dialysis?

What is the issue?

Depression is frequently experienced by people treated with dialysis. Dialysis patients consider treatments that help with depression to be a high priority. Despite that fact that psychosocial interventions have been shown to decrease depression in various chronic diseases, we are very uncertain about whether treatments prevent or treat depression for dialysis patients as studies are rare.

What did we do?

This evidence is current to June 2019. We searched the medical literature and identified 33 studies with 2056 participants treated by dialysis. Studies evaluated a range of possible treatments including acupressure, cognitive‐behavioural therapy (CBT), counselling, education, exercise, meditation, motivational interviewing, relaxation techniques, social activity, spiritual practices, support groups, telephone support, visualisation, and voice control compared to usual care or other psychosocial treatments. We also checked the quality of the information in the studies to learn how certain we could be about the results.

What did we find?

We are moderately certain that CBT, exercise, and relaxation techniques probably decrease symptoms of depression for patients treated with long‐term dialysis. Counselling may slightly decrease depression symptoms, while we are uncertain whether acupressure, telephone support, or meditation make any difference. We found moderate certainty evidence that CBT provides higher quality of life for dialysis patients. Studies did not measure effects of psychosocial treatments on major depression, suicide risk, and whether therapies made any difference to anxiety, hospital admissions, or withdrawal from dialysis treated is uncertain. Adverse events from treatment is very uncertain.

Some study authors did not report the methods for their studies clearly, so we could not be certain whether patients truly had a random chance of being in each treatment group or whether the trial results were assessed by people knowing which treatments that patients actually received. For most outcomes, we identified very few studies, which decreased our confidence in the results.

Conclusions

CBT, exercise, and relaxation techniques probably decrease depressive symptoms for dialysis patients while CBT also improves life quality. Counselling may slightly reduce depression among those receiving dialysis. We are not certain whether interventions prevent or treat major depression, anxiety, suicide risk, or withdrawal from dialysis care before death or whether psychological and social treatments have adverse effects.

Summary of findings

Background

Description of the condition

Depression is the most common psychological problem in patients undergoing dialysis (Finkelstien 2000; Kimmel 1993; Levenson 1991). Approximately one‐quarter of dialysis patients meet diagnostic criteria for major depression (Palmer 2013a; Szeifert 2012). The main factors that contribute to the develop of depressive symptoms are medications, reduction of physical function and dietary restrictions (Farrokhi 2014). The Beck Depression Inventory (BDI), Patient Health Questionnaire and Center for Epidemiologic Studies Depression Scale are validated tools for depression in people undergoing haemodialysis (HD), although the optimal screening tool is still uncertain (King‐Wing Ma 2016).

Depression can adversely affect the well‐being of patients receiving long‐term dialysis in several ways. Health‐related quality of life (HRQoL) of patients on chronic dialysis has been shown to correlate more strongly with depression than with dialysis adequacy measures (Martin 2000; Steele 1996). Depression in dialysis patients is associated with lower adherence to dialysis prescriptions (Kaveh 2001; Kimmel 1995) and recommended fluid restrictions (Everett 1993), which may lead to poorer clinical outcomes (Chilcot 2018). One study (Davies 2003) found a significant association between depression and intolerance to antihypertensive drugs because of nonspecific adverse effects in the general population. This may be of relevance to patients treated with long‐term dialysis as 80% of HD and 50% of peritoneal dialysis (PD) patients are hypertensive (Levey 1998) and hypertension may contribute to the burden of cardiovascular disease in the dialysis population. Depressed patients on PD have been shown to have higher rates of peritonitis (Juergenson 1996). Depression has been associated with increased death for dialysis patients (Hedayati 2010; Palmer 2013b; Weisbord 2014). The risk of hospitalisation is increased in patients with depression (Flythe 2017; Lopes 2002).

Description of the intervention

Depression can be treated by both physical (drugs and electro‐convulsive therapy (ECT)) and psychosocial interventions.

Psychosocial interventions can be defined as those interventions that provide psychological, emotional, or social support without using pharmacological substances. These may include counselling, social group support, cognitive‐behavioural therapy (CBT), relaxation or visualisation techniques, exercise, education, or individual social support including by telephone. Therapies may vary in their mode of delivery, intensity, or methodology, and level of contact with an individual therapist or support worker. Psychosocial interventions may help reduce distressing symptoms, increase coping strategies, increase social connectedness, assist in strategies to address specific disease‐related problems, and decrease anxiety and stress.

How the intervention might work

Several meta‐analysis of psychosocial interventions have found such therapies to be effective treatments for depression in the wider population (Churchill 2001; Dobson 1989; Robinson 1990; Scoggin 1994). In some studies, although participants did not report a specific diagnosis of depression when they were enrolled, psychosocial interventions were effective to prevent depression and impede the progression of the disease (Heshmatifar 2015). Dialysis patients, caregivers, and health professionals have identified depression as a critical outcome for evaluation in nephrology research (Tong 2017); however a previous version of this Cochrane review published in 2005 (Rabindranath 2005) did not identify any randomised controlled trials (RCTs) of psychosocial interventions to treat depression in the dialysis setting. Psychosocial interventions may be especially appropriate for patients on dialysis, since they avoid potential drug interactions and adverse effects of antidepressant medication. Psychosocial interventions are also known to be acceptable to patients and form a core recommendation in guidelines for the treatment of depression in adults (NICE 2018).

Why it is important to do this review

Depression is common for dialysis patients and may increase the substantial burden of symptoms and treatment. Patients, health professional and policy‐makers have identified research on the psychosocial impact of chronic kidney disease (CKD) as a priority (Tong 2015). This is an update of a Cochrane review that was first published in 2005, which identified no relevant studies of psychosocial interventions to treat depression in dialysis patients (Rabindranath 2005). Similarly, a Cochrane review in 2016 of antidepressants for treatment depression in adults with end‐stage kidney disease (ESKD) treated with dialysis included four studies including 170 participants (Palmer 2016). In very low certainty or ungraded evidence, antidepressant therapy had uncertain effects on quality of life (QoL), might reduce depression symptoms and might incur nausea.

Given the priority placed on psychosocial support for dialysis by patients and health professionals, the very low certainty of existing evidence for depression treatment, and the poor outcomes associated with depression in the dialysis setting, our aim was to provide an updated summary of the evidence of the benefits and potential harms of psychosocial interventions among adults with ESKD treated with dialysis.

Objectives

To assess the effect of using psychosocial interventions versus usual care or a second psychosocial intervention for preventing and treating depression in patients with ESKD treated with dialysis.

Methods

Criteria for considering studies for this review

Types of studies

We included RCTs and quasi‐RCTs (e.g. studies in which the method of assignment is based on alternation, date of birth or medical record number) of psychosocial interventions for prevention and treatment of depression among adults treated with long‐term dialysis.

Types of participants

Inclusion criteria

We included participants aged 18 years or above undergoing dialysis (either HD or PD) for ESKD with or without a diagnosis of depression.

See Differences between protocol and review.

Exclusion criteria

We excluded studies evaluating treatment for other psychiatric disorders including bipolar affective disorder.

Types of interventions

We included studies that compared a psychosocial intervention (such as cognitive and behavioural therapies, exercise training, and counselling) versus usual care or a second psychosocial intervention. We excluded studies comparing psychosocial interventions with drugs or ECT.

Types of outcome measures

We did not exclude studies that did not measure or report review outcomes.

We collected outcome data for depression by any measure and at any time point including incidence of major depression, depression (any severity), and depression score at end of treatment (any measure).

Primary outcomes

Depression (any measure)
HRQoL

Secondary outcomes

Anxiety (any measure)
Cognitive function (any measure)
Hospitalisation
Death from any cause
Suicide or suicide attempts
Adherence to dialysis treatment
Withdrawal from dialysis treatment
Withdrawal from trial intervention
Adverse events

Search methods for identification of studies

Electronic searches

We searched the Cochrane Kidney and Transplant Register of Studies up to 21 June 2019.The specialised register contains studies identified from the following sources.

Monthly searches of the Cochrane Central Register of Controlled Trials (CENTRAL)
Weekly searches of MEDLINE OVID SP
Handsearching of kidney‐related journals and the proceedings of major kidney and transplant conferences
Searching of the current year of EMBASE OVID SP
Weekly current awareness alerts for selected kidney journals
Searches of the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.

Studies contained in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE based on the scope of Cochrane Kidney and Transplant. Details of search strategies, as well as a list of handsearched journals, conference proceedings and current awareness alerts, are available on the Cochrane Kidney and Transplant website.

See Appendix 1 for search terms used in strategies for this review.

Searching other resources

Reference lists of review articles, relevant studies and clinical practice guidelines.
Letters seeking information about unpublished or incomplete trials to investigators known to be involved in previous studies.
For the original review, the American College of Physicians Database and PsycINFO were also searched.

Data collection and analysis

Selection of studies

For this 2019 update, two authors independently reviewed study titles and abstracts. Full text articles of studies considered potentially relevant were obtained and reviewed for eligibility by both authors. We consulted a third author to resolve discrepancies if necessary. We reassessed eligibility of studies excluded in the last version of the review (Rabindranath 2005) because of changes to the review criteria.

Data extraction and management

For this update, data extraction and assessment of risk of bias was performed by two authors using standardised data extraction forms. Disagreements not resolved by discussion between authors could be referred to a third author. Studies reported in languages other than English were translated before data extraction. Where more than one report of a study was identified, data were extracted from all reports. Where there were discrepancies between reports, data from the primary source were used. Study authors were contacted for additional information about studies.

We extracted the following information:

Methods: type of study design, setting, country, funding sources, time frame, duration of follow‐up
Participants: number of participants randomised to each group, number of analysed participants, inclusion criteria, exclusion criteria, age, sex, antidepressant medication
Interventions: details of intervention
Outcomes: all outcomes measured by study authors summary statistics of continuous data (mean, standard deviation (SD) and dichotomous data (number who experienced endpoint and number at risk).

Assessment of risk of bias in included studies

Two authors independently assessed methodological reporting using the Cochrane risk of bias assessment tool (Higgins 2011) (see Appendix 2).

We assessed the following:

Was there adequate sequence generation (selection bias)?
Was allocation adequately concealed (selection bias)?
Was knowledge of the allocated interventions adequately prevented during the study (detection bias)?
- Participants and personnel (performance bias)
- Outcome assessors (detection bias)
Were incomplete outcome data adequately addressed (attrition bias)?
Are reports of the study free of suggestion of selective outcome reporting (reporting bias)?
Was the study apparently free of other problems that could put it at a risk of bias?

Measures of treatment effect

Dichotomous data

For dichotomous outcomes (hospitalisation, death, suicide or suicide attempts, withdrawal from trial treatment, withdrawal from dialysis, adverse events), results were expressed as risk ratio (RR) with 95% confidence intervals (CI).

Continuous data

Where continuous scales of measurement were used to assess the effects of treatment (HRQoL, depression score), we used mean differences (MD) where the studies employed the same outcome measure. Where the studies used different scales to assess a given outcome, we used the standardised mean difference (SMD). We considered SMD of 0.2 a small effect size, SMD 0.5 a medium effect size and SMD 0.8 a large effect size (Cohen 1988).

Change scores and missing standard deviations

We included change scores and missing standard deviations (SD) according to the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

Unit of analysis issues

Cross‐over studies

A primary concern with cross‐over trials is the "carry‐over" effect in which the effect of the intervention treatment influences the participant's response to the subsequent intervention in the second phase of the study. As a consequence, participants entering the second phase of the study may differ systematically from their "baseline" state even after a wash‐out phase. To minimise the carry‐over effect, we only extracted data from the first phase of the study, prior to cross‐over.

Dealing with missing data

Any further information required from the original author was requested by written correspondence and any relevant information obtained was to be included in the review. Evaluation of important numerical data such as screened, randomised patients as well as intention‐to‐treat, as‐treated and per‐protocol population were carefully performed. Attrition rates, for example drop‐outs, losses to follow‐up and withdrawals were investigated. Issues of missing data and imputation methods (for example, last‐observation‐carried‐forward) were critically appraised (Higgins 2011).

Assessment of heterogeneity

We first assessed the heterogeneity by visual inspection of the forest plot. We then quantified statistical heterogeneity using the I² statistic, which describes the percentage of total variation across studies that is due to heterogeneity rather than sampling error (Higgins 2003). A guide to the interpretation of I² values was as follows.

0% to 40%: might not be important
30% to 60%: may represent moderate heterogeneity
50% to 90%: may represent substantial heterogeneity
75% to 100%: considerable heterogeneity.

The importance of the observed value of I² depends on the magnitude and direction of treatment effects and the strength of evidence for heterogeneity (e.g. P‐value from the Chi² test, or a confidence interval for I²) (Higgins 2011).

Assessment of reporting biases

Reporting bias may occur when the direction and/or magnitude of a study's results influence a decision to publish the study. Empirical evidence suggests that studies with statistically significant findings are more likely to be submitted and accepted for publication, and may lead to over‐estimation of the true treatment effect. To assess whether studies in our meta‐analyses may be affected by publication bias, we planned to enter data into a funnel plot when a meta‐analysis included the results of at least 10 studies and in the absence of moderate or substantial heterogeneity (Higgins 2011). In this version of the review, there were insufficient data to generate funnel plots.

Data synthesis

Data were summarised using the random‐effects model and the fixed‐effect model was also used to ensure robustness of the model chosen and susceptibility to outliers.

Subgroup analysis and investigation of heterogeneity

Although subgroup analyses have to be treated with caution, as they are hypothesis‐forming rather than hypothesis‐testing, we considered conducting a priori defined analyses in order to explore whether methodological and clinical differences between the trials may have systematically influenced the differences that were observed in the treatment outcomes.

Sensitivity analysis

We considered performing sensitivity analyses to explore the influence of the following factors on effect size, although in this version of the review, there were insufficient data to generate sensitivity analyses.

Repeating the analysis excluding unpublished studies
Repeating the analysis taking account of risk of bias, as specified
Repeating the analysis excluding any very long or large studies to establish how much they dominate the results
Repeating the analysis excluding studies using the following filters: diagnostic criteria, language of publication, source of funding (industry versus other), or country.

'Summary of findings' tables

We presented the main results of the review in 'Summary of findings' tables. These tables present key information concerning the quality of the evidence, the magnitude of the effects of the interventions examined, and the sum of the available data for the main outcomes (Schunemann 2011a). The 'Summary of findings' tables also include an overall grading of the evidence related to each of the main outcomes using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach (GRADE 2008; GRADE 2011). The GRADE approach defines the quality of a body of evidence as the extent to which one can be confident that an estimate of effect or association is close to the true quantity of specific interest. The quality of a body of evidence involves consideration of within‐trial risk of bias (methodological quality), directness of evidence, heterogeneity, precision of effect estimates and risk of publication bias (Schunemann 2011b).

We used the GRADE process to assess the certainty of the body of the evidence associated with the following outcomes.

Major depression
Depression score (any measure)
Anxiety
QoL
Withdrawal from dialysis
Withdrawal from intervention
Death (any cause)

We constructed four 'Summary of Findings' tables for the following comparisons in this review.

CBT versus usual care
Counselling versus usual care
Exercise versus usual care
Relaxation techniques versus usual care
Spiritual practice versus usual care

One author completed the tables in consultation with a second author.

Results

Description of studies

Results of the search

Search results are shown in Figure 1. For this 2019 review update, we screened 72 titles and abstracts. We reclassified seven studies in seven publications from the 2005 review as eligible due to the expanded criteria in this review to include participants without depression at baseline. We removed 21 studies (21 publications) from the 2005 review as they were not RCTs. From the 2019 search update, we identified 26 new studies (33 reports) that met the review eligibility criteria (Characteristics of included studies); 11 studies (29 reports) were and excluded, and there are 7 ongoing studies.

Included studies

See Characteristics of included studies.

We included 33 studies in 42 publications. One study (Cukor 2014) was a cross‐over study design in which participants were administered each of the study interventions sequentially without a washout period. One study (Dziubek 2016) was a quasi‐randomised study.

Study design, setting and characteristics

Study duration varied from three weeks to one year. Studies were conducted in fifteen different countries including Brazil (Duarte 2009), Canada (Thomas 2017), Greece (Kouidi 1997; Kouidi 2010; Ouzouni 2009), Indonesia (Sofia 2013), Iran (Babamohamadi 2017; Bahmani 2016; Espahbodi 2015; Heshmatifar 2015; Kargar Jahromi 2016), Jordan (Al Saraireh 2018), Malaysia (Hmwe 2015), Mexico (Lerma 2017), Poland (Bargiel‐Matusiewicz 2011; Bargiel‐Matusiewicz 2011a; Dziubek 2016), Singapore (HED‐SMART 2011), Taiwan (Lii 2007; Tsai 2015), UK (iDiD 2016; Krespi 2009; Vogt 2016), Tunisia (Frih 2017), Turkey (Sertoz 2009), and USA (Beder 1999; Carney 1987; Cukor 2014; Erdley 2014; Frey 1999; Leake 1999; Mathers 1999; Matthews 2001). One study (Thomas 2017) received at least some funding from companies, while 32 studies provided no specific details about funding sources.

Study participants

The 33 studies included 2056 randomised participants treated with HD. The sample size varied from 9 participants (Vogt 2016) to 235 participants (HED‐SMART 2011). One study (Sofia 2013) did not report the number of participants. The mean study age ranged from 36.1 years (Carney 1987) to 73.9 years (Erdley 2014), with a median of 52.4 years.

Interventions

Details of interventions in each study are presented in the Characteristics of included studies and in Table 6.

1. TIDieR framework of interventions descriptions for included studies.

Study ID	Intervention	Control	Aim	What	How	Who, where, when	Tailoring/modification	How well: planned	How well: actual
Al Saraireh 2018	CBT	Education	To assess the level of depression among patients undergoing HD and to compare the effectiveness of  CBT versus psycho education	Traditional CBT sessions protocol was compared with psycho educational therapy	Both groups attended seven sessions of one hour. The control group discussed on education about stress management and relaxation, focusing on optimism, deep breathing and problem‐solving skills	In private rooms within the dialysis  units by two expert researchers, for 7 sessions (3 months)	‐	All sessions were administered on one‐to‐one  basis	105 completed the study
Babamohamadi 2017	Spiritual practice	Usual care	To examine the effect of the Holy Qur'an recitation (music therapy) on depressive symptoms	Holy Qur'an was recited aloud with the voice of Shateri (a well‐known actor of the Qur'an)	Listened to the Qur'an recitation (adds religious content to the pleasant, adding further to the relaxation, focus on pleasant sounds, and distraction from negative ruminations) using an MP3 player with headphones	Shateri provided the intervention 3 times a week for 20 min each during 1‐month, in the clinic	‐	‐	54 completed the study
Bahmani 2016	Counselling	Usual care	To examine a method that considers the needs of patients under special treatment such as dialysis	Combination of treatment including some elements of "existentialism" philosophy and a "cognitive" approach	Discussions on social support, face loneliness, isolation, death, losing the opportunity to job, losing education, emotional difficulties and the pain of treatment	Researcher provided the intervention for 12 sessions of 90 min, for 3 months, in the clinic	‐	‐	20 completed the study
Bargiel‐Matusiewicz 2011	Voice recording	Usual care	To assess the  influence of a psychological intervention on the cognitive appraisal	Based on the principles of the Ericksonian therapy and used therapeutic metaphors	Listened to a CD (20 min) with a recorded psychological intervention	Twice a day for 3 weeks. Researchers carried out the intervention in a natural environment	‐	‐	60 completed the study
Bargiel‐Matusiewicz 2011a	Counselling	Usual care	To assess if psychological intervention improve the level of acceptance of illness	Participants attended in meetings	‐	Psychologist provided the intervention for 5 weeks	‐	‐	The number of subject who completed the study was not clear
Beder 1999	Counselling	Usual care	To provide existing dialysis programs  with a supported model of service	Basic social support consisted of a psycho‐educational and support components	Providing  information on patients' needs and received additional social support component	Renal social workers provided the intervention  in the hospital for 3 months	Helping the patients in mobilizing and assessing and accessing additional supports as needed	‐	46 completed the study
Carney 1987	Exercise	Support group	To assess the effect of exercise training on the psychosocial rehabilitation	5‐min sessions on a stationary bicycle ergometer and fast walking interspersed with 5‐mi rest periods	All patients were provided with bicycle ergometers for home use and jogging 1 to 2 laps	3 time a week at home for 45 to 60 min for 6 months	‐	‐	17 completed the study
Cukor 2014	CBT	Usual care	To test the efficacy of an individual chairside CBT	Standard CBT intervention for depression was adapted for HD patients	At the end of the first period, treatments were inverted	Psychologists provided the intervention in chairside, during dialysis, for 3 months	‐	‐	59 completed the study
Duarte 2009	CBT	Usual care	To assess the effectiveness of CBT in ESKD patients with a diagnosis of major depression	Educating patients on several aspects of kidney disease, dialysis, depression	Provided self‐monitoring of mood status; cognitive restructuring; programming pleasant activities; training on social abilities; exercises	Psychologists provided the intervention (1 hour and 30 min) during dialysis, for 3 months	‐	Another psychologist checked written records to monitor the intervention	74 completed the study
Dziubek 2016	Exercise	Exercise	To evaluate the effects of exercise on depression and anxiety, and compared 2 different types of training in dialysis	Endurance and resistance training were performed	Ergonometer group performed short warm‐up, 10 to 15 min of training using a motorized exercise therapy device and 35 to 50 min ride on the cycle ergometer. Resistance group performed strength exercises with weights, balls and Thera Bands and final relaxation	Nephrologist and cardiologist supervised the training performed 3 times a week for 6 months in the clinic	The number of evolutions and load were constant, individually tailored to the patient depending on the tolerance of the exercise	Heart rate, blood pressure and the degree of fatigue were monitored	28 participants completed the study
Erdley 2014	Counselling	Usual care	To assess the efficacy of problem‐solving therapy in reducing depressive symptoms.	Providing intervention to manage problems and improve individual coping and problem‐solving ability.	Provided orientation to problem solving, evaluating and choosing solutions, and identifying steps to achieve solutions.	Meeting with social workers were provided once weekly in the dialysis unit for 1 hour, for 6 weeks.	‐	‐	33 completed the study.
Espahbodi 2015	Education	Usual care	To investigate psychological impacts of psycho education on anxiety and depression	Psycho education sessions	Sessions of anatomy,  pathophysiology, variety of treatments, stress management, problem‐solving skills, and muscle relaxation	3 sessions of one‐hour, in the clinic with a psychiatrist was delivered for 1 month	‐	‐	55 completed the study
Frey 1999	Exercise	Usual care	To evaluate the difference in kilocalorie and protein intake in ESKD patients who perform or not perform exercise	Exercise patients cycled on stationary bicycle ergometers	5 minutes warm‐up and 5 minutes cool down. Cycling periods were followed by gradually increasing tension	Investigator supervised the intervention for 12 weeks	‐	‐	All participants completed the study
Frih 2017	Spiritual practice	Exercise	To determine whether listening to Holy Qur'an recitation improve the effects of exercise on physiological measures	Resistance training consisted of dynamic exercises. Endurance training consisted of ergo cycle exercise. The intervention group listened to the Holy Qur'an	The Holy Qur'an was recited by the reader Al‐Dosari, who reads with a relaxing and calming voice. The recitation was played through headphones on MP3	The reader Al‐Dosari recited and participants listened verses 3 times a week during 24 weeks, (20 min), in the clinic	The volume was adjusted according to the patient’s comfort	A Borg score of  5 to 6 for dyspnoea or fatigue was set as a target	All participants completed the study
HED‐SMART 2011	Counselling	Usual care	To determine the efficacy of the intervention on  biochemical markers, clinical status, QoL and patient satisfaction	Participants performed the NKF‐NUS self‐management intervention to take control of their condition	3 main interactive sessions held every two weeks and one booster session Intervention components will include problem solving, overcoming barriers, challenging beliefs, conducting brainstorming sessions, goal setting, and reinforcement. Participants also received an educational booklet	4 sessions (90 min each) were facilitated by two health care professionals	Used feedback, modelling of problem‐solving strategies through group support and guidance for individual self‐management efforts	Patients were contacted by telephone to assess the progress they were making  with their goals	All participants completed the study
Heshmatifar 2015	Relaxation	Usual care	To assess the efficacy of Benson technique to improve depressive symptoms	The training sessions included discussions  about relaxation. The participants were asked to perform the relaxation exercises	Participants performed exercises for 20 minutes. The training method, an educational pamphlet and a CD were handed to subjects to perform the exercises	Researcher provided the intervention in the clinic, for 1 month	‐	Subjects’ compliance was ensured through text messages	All participants completed the study
Hmwe 2015	Acupressure	Usual care	To evaluate the effects of acupressure on depression, stress, anxiety and general psychological distress	Acupoints  for depression, anxiety, and stress was based on the concepts of Chinese medicine	Acupressure is performed by applying consistent fingertip pressure on selected acupoints with rotational movements	Investigator provided acupressure 3 times/ week over 4 weeks, in the clinic	‐	A supervisor monitored to ensure that the  intervention was performed as the protocol declared	102 the study. 108 were analysed (intention to treat)
iDiD 2016	Telephone support + CBT	CBT	To explore adherence and examine the efficacy of online CBT sessions and therapist support  calls	All patients had access to the iDiD online intervention Patients in the supported arm received three 30 min telephone calls	iDiD sessions were designed to last approximately 60 min. iPads were available at dialysis units. The researcher guided the patient to the most relevant components of sessions	Telephone support was delivered by a trained psychological well‐being researcher	For 6 patients was  generate an email address and provide brief Internet education, thus these patients received a higher degree of technical support and face to face contact	Patients received  reminders. Support calls were audio recorded for supervision and checks	23 completed the study
Kargar Jahromi 2016	Telephone support	Usual care	To evaluate the effect of nurse‐led telephone follow‐up on depression, anxiety and stress	The intervention group received telephone follow‐up after dialysis and conventional treatment	Key subjects: communication,  cognition/development, breathing/circulation, nutrition, elimination, sleep, tissue, pain,  sexuality, activity and psychosocial/spirituality/culture	Researchers provided every session (30 minutes), for a month	‐	The content of the call followed a script to ensure consistency	54 completed the study
Kouidi 1997	Exercise	Usual care	To assess the psychosocial effects of exercise training.	The intervention was the exercise training rehabilitation program.	The telemetric spirometer assessed the maximal oxygen consumption during the performance.	Psychologist and trainer supervised the exercise, for 6 months	The intensity and duration of the exercise sessions was gradually increased.	‐	31 completed the study.
Kouidi 2010	Exercise	Usual care	To investigate the  effects of exercise on emotional parameters in HD patients	The intervention was the exercise training rehabilitation program	5 min warm‐up, 30 to 60 min of cycling, 20 min strengthening time followed by a 5 min cooling off	3 times a week during the first 2 hours of HD session	‐	‐	38 completed the study
Krespi 2009	Relaxation	Control 1 Voice control Control 2 Usual care	To investigate the  effects of relaxation	The experimental group received specific visual imagery (using metaphors), delivered by audiotapes	Each tape lasted for 25 minutes, relaxation and imagery took 20 minutes for the techniques and 5 minutes for the specific imaging technique	Researchers provided the intervention 3 to 4 times/week for 6 weeks, during HD	‐	The procedures support patients and answer questions	103 completed the study
Leake 1999	Motivational interviewing	Control 1 Motivational interviewing Control 2 Video recording	To evaluate the therapeutic benefits of strategic self‐presentation	Patients participated in a videotaped interview where they portrayed their coping strategies	Patients were asked to provide candid testimonies about their own difficulties on problems with chronic illness	The researchers provided the interview for 1 month	‐	Patients were given the opportunity to revise the video tape	41 completed the study
Lerma 2017	CBT	Usual care	To reduce mild and moderate depression and anxiety symptoms in patients	Intervention consisted of positive self‐reinforcement, deep breathing, muscle relaxation, and cognitive  restructuring	All components of the programme  were adapted to the clinical context of patients with ESRD using images, examples,  words, exercises, and everyday scenarios that were relevant to them	The therapist provided the intervention in the clinic during 5 weekly sessions that lasted 2 hours each	Patients who were identified as having severe depression symptoms (BDI > 29 points) were referred for appropriate psychiatric evaluation and care	The therapist recorded comments and  received feedback from an expert	49 completed the study
Lii 2007	CBT	Usual care	To investigate the effects of intervention on depression and QoL	The treatment helped participants to evaluate problem and solve irrational beliefs	Self‐management of depression; restructuring beliefs; stress management; and health education	Nurses provided the intervention in the clinic, once a week, for 2 hours	‐	‐	48 completed the study
Mathers 1999	Education	Usual care	To determine if the psychosocial education sessions had an effect on the adaptation level	7 audiotapes and a companion text module, provided information	Each module consisted in several questions to help participants focus on the topic of the day	Investigators provided 7 sessions, 2 days a week (20 min each), for 4.5 weeks	The investigator was available to answer any questions	‐	6 completed the study
Matthews 2001	Spiritual practice	Control 1 Visualisation Control 2 Usual care	To explore the effect of intercessory prayer, positive visualisation, and outcome expectancy	Christian prayer group and transpersonal (nonreligious) positive visualisation group improved illness	In the intervention group there were 6 intercessors who preyed. In the positive visualisation group, 6 psychology interns focused on patients' problems, using audiotapes	The prayers and the visualisation process took 5 to 15 min/5 days, for 6 weeks	‐	An individual checked if the intercessory prayer was performed	The number of subject who completed vary (absent during data collection)
Ouzouni 2009	Exercise	Usual care	To assess the effects of intradialytic exercise training on HRQoL	Patients in the exercise group followed an exercise rehabilitation programme	Each exercise session included 30 min of cycling and 30 min of strengthening and flexibility exercises (20 min cycling at desired workload and 5 min cool‐down)	Physiologists provided the exercised 3 times weekly (90 min each), per 10 months (in the centre)	For the cycling exercise specific devices, which were adjusted to each patient’s bed, were used	Their cardiac rhythm and blood pressure were monitored continuously	33 completed the study
Sertoz 2009	Social activity	Usual care	To investigate the impact of social  activity on anxiety, depression, self‐esteem and QoL	Patients were engaged in a play. The play chosen was one by Tuncay Cucenoglu (drama organisation)	“The Painter”, by displaying the social structure and diversity of ideas, maintains the audience’s curiosity. The control group participated as the audience	At the baseline and after 4 months	‐	‐	The number of subject who completed the study was not clear
Sofia 2013	Relaxation	Control	To determine the effect of Latihan Pasrah Diri (LPD) on QoL in HD patients with depression	The intervention group received LPD	LPD was a method combining relaxation and remembrance with a focus on breathing exercises and words contained in the "zirk" (relaxation and repetitive prayer)	21 days	‐	‐	‐
Thomas 2017	Meditation	Usual care	To determine whether the intervention  reduced depression and anxiety symptoms	Chairside meditative practices were performed 4 meditation techniques drawn from mindfulness‐based.	Cognitive therapy were practiced in alternating fashion, on the basis of patient preference. In these techniques, the participant is guided to direct their attention toward specific elements of their experience	Interventionists performed 3 times/week,  during HD, lasting 10 to 15 min, for 8 weeks	‐	Patients were encouraged to practice the techniques  at home, but did not have formal logs	32 completed the study
Tsai 2015	Relaxation	Control	To examine the efficacy of a nurse‐led, in reducing depressive symptoms and improving sleep	The dialysis nurse administered the audio device–guided breathing training in a quiet room	Patients listened to pre‐recorded  instructions on breathing technique and then practiced the breathing exercise	A trained nurse provided the intervention in the clinic: 8 sessions, twice weekly for 4 weeks	Each patient received an individual coaching session	The nurse supervised to ensure that participants  performed them correctly	57 completed the study
Vogt 2016	Counselling	Usual care	To examine the feasibility and appropriateness of the intervention	Participants received Acceptance and Commitment Therapy (ACT)	The intervention was based on a self‐help manual with weekly telephone support	6 weeks.	‐	‐	‐

Cognitive‐behavioural therapy (CBT) versus with usual care for depression in people treated with dialysis
Patient or population: people with ESKD Settings: dialysis Intervention: CBT Comparison: usual care
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect  (95% CI)	No. of participants  (studies)	Certainty of the evidence  (GRADE)	Comments
	Assumed risk	Corresponding risk
	Usual care	CBT
Major depression Mini International Neuropsychiatric Interview (MINI) (median follow‐up: 39.6 weeks)	Not estimable¹	Not estimable	Not estimable	Insufficient data observations	Not estimable	Studies were not designed to measure effects of Cognitive behavioural therapy on major depression
Depression (any severity, including mild, moderate and severe depression) Investigators measured depression using the Beck Depression Inventory (BDI). A higher score is indicative of more depressive symptoms. (median follow‐up: 17.7 weeks)	The mean Beck Depression Inventory ranged across control groups from 14.5 to 21.39	The mean Beck Depression Inventory score in the intervention groups was 6.10 lower (95% CI ‐8.63 to ‐3.57)	MD ‐6.10 (95% CI ‐8.63 to ‐3.57)	230 (4)	⊕⊕⊕⊝  moderate ²	Cognitive behavioural therapy probably decreases depressive symptoms
Health‐related quality of life Investigators measured health‐related quality of life using different instruments: Quality of Life Scale (QoL) and HRQoL Short Form‐36, Kidney Disease and Quality of Life‐Short Form (KDQOL‐SF‐36) (median follow‐up: 17.7 weeks). A higher score is indicative of higher perceived of QoL.	The mean quality of life score ranged across control groups from 40.46 to 110.6	The mean QoL score in the intervention groups was 0.51 standard deviations higher (95% CI 0.19 to 0.83)	SMD 0.51 (95% CI 0.19 to 0.83)	230 (4)	⊕⊕⊕⊝  moderate ²	As a rule of thumb, 0.2 SMD represents a small effect size, 0.5 SMD a moderate effect size and 0.8 SMD a large effect size. Cognitive behavioural therapy probably moderately improves health‐related quality of life
Anxiety Beck Anxiety Inventory (BAI) (median follow‐up: 9 weeks)	Not estimable³	Not estimable	Not estimable	Insufficient data observations	Not estimable.	Studies were not designed to measure effects of cognitive behavioural therapy on anxiety
Withdrawal from dialysis	No data observations	Not estimable	No observations	Insufficient data observations	Not estimable.	Studies were not designed to measure effects of cognitive behavioural therapy on withdrawal from dialysis
Withdrawal from intervention	No data observations	Not estimable	No observations	Insufficient data observations	Not estimable.	Studies were not designed to measure effects of cognitive behavioural therapy on withdrawal from intervention
Death (any cause) (median follow‐up: 24.3 weeks)	13.8 per 1000	‐1.2 per 1000  (95% CI 4.83 to 47.61)	RR 1.09 (95% CI 0.35 to 3.45)	145 (2)	⊕⊕⊝⊝  low ^{4, 5}	It is uncertain whether CBT makes any difference to death (any cause)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).  ESKD: end‐stage kidney disease; CI: Confidence interval; MD: mean difference; SMD: standardised mean difference; RR: Risk Ratio; HRQoL: health‐related quality of life
GRADE Working Group grades of evidence  High quality: Further research is very unlikely to change our confidence in the estimate of effect.  Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.  Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.  Very low quality: We are very uncertain about the estimate.

Counselling versus usual care for depressive outcomes in people treated with dialysis
Patient or population: people with ESKD Settings: dialysis Intervention: counselling¹ Comparison: usual care
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect  (95% CI)	No. of participants  (studies)	Certainty of the evidence  (GRADE)	Comments
	Assumed risk	Corresponding risk
	Usual care	Counselling
Major depression	No data observations	Not estimable	No observations.	Insufficient data observations	Not estimable	Studies were not designed to measure effects of counselling on major depression
Depression (any severity, including mild, moderate and severe depression) Investigators measured depression using the Beck Depression Inventory (BDI). A higher score is indicative of more depressive symptoms. (median follow‐up: 13.2 weeks)	The mean depression score ranged across control groups from ‐2.43 to 18.54	The mean depression score in the intervention groups was  3.84 lower (95% CI ‐6.14 to ‐1.53)	MD ‐3.84 (95% CI ‐6.14 to ‐1.53)	99 (3)	⊕⊕⊝⊝  low ^2,3	Counselling may decrease depressive symptoms
HRQoL Kidney Disease Quality of Life (KDQOL‐36) (median follow‐up: 6 weeks)	Not estimable⁴	Not estimable	Not estimable	Insufficient data observations	Not estimable	Studies were not designed to measure effects of counselling on health related quality of life
Anxiety	No data observations	Not estimable	No observations	Insufficient data observations	Not estimable	Studies were not designed to measure effects of counselling on anxiety
Withdrawal from dialysis	No data observations	Not estimable	No observations	Insufficient data observations	Not estimable	Studies were not designed to measure effects of counselling on withdrawal from dialysis
Withdrawal from intervention (median follow‐up: 6 weeks)	Not estimable⁵	Not estimable	Not estimable	Insufficient data observations	Not estimable	Studies were not designed to measure effects of counselling on withdrawal from intervention
Death (any cause) (median follow‐up: 22.8 weeks)	2.5 per 1000	‐1.7 per 1000  (95% CI 0.8 to 22.03)	RR 1.69 (95% CI 0.32 to 8.81)	270 (2)	⊕⊕⊝⊝  low ^2,6	It is uncertain whether counselling makes any difference to death
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).  ESKD: end‐stage kidney disease; CI: Confidence interval; MD: mean difference; RR: Risk Ratio; HRQoL: health‐related quality of life
GRADE Working Group grades of evidence  High quality: Further research is very unlikely to change our confidence in the estimate of effect.  Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.  Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.  Very low quality: We are very uncertain about the estimate.

Exercise versus usual care for depression in people treated with dialysis
Patient or population: people with ESKD Settings: dialysis Intervention: exercise Comparison: usual care
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect  (95% CI)	No of Participants  (studies)	Certainty of the evidence  (GRADE)	Comments
	Assumed risk	Corresponding risk
	Usual care	Exercise
Major depression (median follow‐up: 44 weeks)	86.02 per 1000	45.59 per 1000  (95% CI 23.23 to 69.68)	RR 0.47 (95% CI 0.27 to 0.81)	108 (3)	⊕⊕⊝⊝  low ^1,2	Exercise may decrease risk of major depression
Depression (any severity, including mild, moderate and severe depression) Investigators measured depression using the Beck Depression Inventory (BDI). A higher score is indicative of more depressive symptoms (median follow‐up: 44 weeks)	The mean depression score ranged across control groups from  19.4 to22.1	The mean depression score in the intervention groups was 7.61 lower (95% CI ‐9.59 to ‐5.63)	MD ‐7.61 (95% CI ‐9.59 to ‐5.63)	108 (3)	⊕⊕⊕⊝  moderate ¹	Exercise probably decreases depressive symptoms
HRQoL Investigators measured health related quality of life using the Quality of Life Index (QLI). A higher score is indicative of higher perceived of QoL (median follow‐up: 35.2 weeks)	The mean QoL score ranged across control groups from 5.6 to 6.3	The mean QoL score in the intervention groups was 3.06 higher (95% CI 2.29 to 3.83)	MD 3.06 (95% CI 2.29 to 3.83)	64 (2)	⊕⊕⊝⊝  low ^1,3	Exercise may improve HRQoL
Anxiety Hospital Anxiety and Depression Scale (HADS) (median follow‐up: 52.1 weeks)	Not estimable⁴	Not estimable	Not estimable	Insufficient data observations	Not estimable	Studies were not designed to measure effects of exercise on anxiety
Withdrawal from dialysis	No data observations	Not estimable	No observations	Insufficient data observations	Not estimable	Studies were not designed to measure effects of exercise on withdrawal from dialysis
Withdrawal from intervention	No data observations	Not estimable	No observations	Insufficient data observations	Not estimable	Studies were not designed to measure effects of exercise on withdrawal from intervention
Death (any cause)	No data observations	Not estimable	No observations	Insufficient data observations	Not estimable	Studies were not designed to measure effects of exercise on death
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).  ESKD: end‐stage kidney disease; CI: Confidence interval; RR: Risk Ratio; MD: mean difference; HRQoL: health‐related quality of life
GRADE Working Group grades of evidence  High quality: Further research is very unlikely to change our confidence in the estimate of effect.  Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.  Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.  Very low quality: We are very uncertain about the estimate.

Relaxation techniques versus usual care for depression in people treated with dialysis
Patient or population: people with ESKD Settings: dialysis Intervention: relaxation techniques¹ Comparison: usual care
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect  (95% CI)	No. of participants  (studies)	Quality of the evidence  (GRADE)	Comments
	Assumed risk	Corresponding risk
	Usual care	Relaxation techniques
Major depression	No data observations	Not estimable	No observations	Insufficient data observations	Not estimable	Studies were not designed to measure effects of relaxation techniques on major depression
Depression (any severity, including mild, moderate and severe depression) Investigators measured depression using the Beck Depression Inventory (BDI). A higher score is indicative of more depressive symptoms. (median follow‐up: 4.2 weeks)	The mean depression score ranged across control groups from 9.56 to 30.83	The mean depression score in the intervention group was 5.77 lower (95% CI ‐8.76 to ‐2.78)	MD ‐5.77 (95% CI ‐8.76 to ‐2.78)	122 (2)	⊕⊕⊕⊝  moderate ²	Relaxation techniques probably decrease depressive symptoms
HRQoL Investigators measured health‐related quality of life using the Health Status Questionnaire Short Form (SF‐36) (median follow‐up: 6 weeks)	Not estimable³	Not estimable	No observations	Insufficient data observations	Not estimable	Studies were not designed to measure effects of relaxation techniques on HRQoL
Anxiety	No data observations	Not estimable	No observations	Insufficient data observations	Not estimable	Studies were not designed to measure effects of relaxation techniques on anxiety
Withdrawal from dialysis	No data observations	Not estimable	No observations	Insufficient data observations	Not estimable	Studies were not designed to measure effects of relaxation techniques on withdrawal from dialysis
Withdrawal from intervention	No data observations	Not estimable	No observations	Insufficient data observations	Not estimable	Studies were not designed to measure effects of relaxation techniques on withdrawal from intervention
Death (any cause)	No data observations	Not estimable	No observations	Insufficient data observations	Not estimable	Studies were not designed to measure effects of relaxation techniques death
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).  ESKD: end‐stage kidney disease; CI: Confidence interval; MD: mean difference; HRQoL: health‐related quality of life
GRADE Working Group grades of evidence  High quality: Further research is very unlikely to change our confidence in the estimate of effect.  Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.  Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.  Very low quality: We are very uncertain about the estimate.

Spiritual practice versus usual care for depression in people treated with dialysis
Patient or population: people with ESKD Settings: dialysis Intervention: spiritual practice¹ Comparison: usual care
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect  (95% CI)	No of Participants  (studies)	Certainty of the evidence  (GRADE)	Comments
	Assumed risk	Corresponding risk
	Usual care	Spiritual practice
Major depression	No data observations	Not estimable	No observations	Insufficient data observations	Not estimable	Studies were not designed to measure effects of spiritual practice on major depression
Depression (any severity, including mild, moderate and severe depression) Investigators measured depression using different instruments: Beck Depression Inventory (BDI) and Brief Symptom Inventory (BSI). A higher score is indicative of more depressive symptoms. (median follow‐up: 5.2 weeks)	The mean depression score ranged across control groups from 31.6 to 53.53	The mean depression score in the intervention groups was 1.00 standard deviations lower (95% CI ‐3.52 to 1.53)	SMD ‐1.00 (95% CI ‐3.52 to 1.53)	116 (2)	⊕⊝⊝⊝  very low ^2,3,4	As a rule of thumb, 0.2 SMD represents a small effect size, 0.5 SMD a moderate effect size and 0.8 SMD a large effect size. As SMD is ‐1.00, it is very uncertain whether spiritual practice makes any difference to depressive symptoms
Health‐related quality of life Health Status Questionnaire Short Form (SF‐36) (median follow‐up: 6 weeks)	Not estimable⁵	Not estimable	Not estimable	Insufficient data observations	Not estimable	Studies were not designed to measure effects of spiritual practice on quality of life
Anxiety Brief Symptom Inventory (BSI) (median follow‐up: 6 weeks)	Not estimable⁶	Not estimable	Not estimable	Insufficient data observations	Not estimable	Studies were not designed to measure effects of spiritual practice on anxiety
Withdrawal from dialysis	No data observations	Not estimable	No observations	Insufficient data observations	Not estimable	Studies were not designed to measure effects of spiritual practice on withdrawal from dialysis
Withdrawal from intervention	No data observations	Not estimable	No observations	Insufficient data observations	Not estimable	Studies were not designed to measure effects of spiritual practice on withdrawal from intervention
Death (any cause)	No data observations	Not estimable	No observations	Insufficient data observations	Not estimable	Studies were not designed to measure effects of spiritual practice on death
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).  ESKD: end‐stage kidney disease; CI: Confidence interval; SMD: standardised mean difference; HRQoL: health‐related quality of life
GRADE Working Group grades of evidence  High quality: Further research is very unlikely to change our confidence in the estimate of effect.  Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.  Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.  Very low quality: We are very uncertain about the estimate.

Date	Event	Description
16 October 2019	New citation required and conclusions have changed	New studies added
16 October 2019	New search has been performed	Expanded inclusion criteria ‐ including trials of participants with and without depression

Date	Event	Description
14 October 2008	Amended	Converted to new review format.
12 May 2005	New citation required and conclusions have changed	Substantive amendment

DATABASE	Search Terms
CENTRAL	MeSH descriptor: [Renal Dialysis] explode all trees MeSH descriptor: [Hemofiltration] explode all trees MeSH descriptor: [Kidney Failure, Chronic] explode all trees dialysis:ti,ab,kw in Trials (Word variations have been searched) haemodialysis or haemodialysis:ti,ab,kw in Trials (Word variations have been searched) hemofiltration or haemofiltration:ti,ab,kw in Trials (Word variations have been searched) hemodiafiltration or haemodiafiltration:ti,ab,kw in Trials (Word variations have been searched) CAPD or CCPD or APD:ti,ab,kw in Trials (Word variations have been searched) "end‐stage kidney" or "end‐stage renal" or "endstage kidney" or "endstage renal":ti,ab,kw in Trials (Word variations have been searched) eskd or eskf or esrd or esrf:ti,ab,kw in Trials (Word variations have been searched) #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 or #10 MeSH descriptor: [Depression] explode all trees MeSH descriptor: [Depressive Disorder] explode all trees MeSH descriptor: [Adjustment Disorders] explode all trees MeSH descriptor: [Adaptation, Psychological] explode all trees depression or depressed or depressive or anxiety or anxious:ti,ab,kw in Trials (Word variations have been searched) #12 or #13 or #14 or #15 or #16 #11 and #17
MEDLINE	exp Renal Dialysis/ exp Hemofiltration/ Kidney Failure, Chronic/ dialysis.tw. (haemodialysis or haemodialysis).tw. (hemofiltration or haemofiltration).tw. (hemodiafiltration or haemodiafiltration).tw. (CAPD or CCPD or APD).tw. (end‐stage kidney or end‐stage renal or endstage kidney or endstage renal).tw. (ESKD or ESKF or ESRD or ESRF).tw. or/1‐10 Depression/ exp Depressive Disorder/ Adjustment Disorders/ exp Adaptation, Psychological/ (depression or depressed or anxiety or anxious).tw. exp Antidepressive Agents/ or/12‐17 and/11,18
EMBASE	exp Renal Replacement Therapy/ (haemodialysis or haemodialysis).tw. (hemofiltration or haemofiltration).tw. (hemodiafiltration or haemodiafiltration).tw. dialysis.tw. (CAPD or CCPD or APD).tw. Chronic Kidney Disease/ Kidney Failure/ Chronic Kidney Failure/ (end‐stage renal or end‐stage kidney or endstage renal or endstage kidney).tw. (ESRF or ESKF or ESRD or ESKD).tw. or/1‐11 exp depression/ and/12‐13

Potential source of bias	Assessment criteria
Random sequence generation Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence	Low risk of bias: Random number table; computer random number generator; coin tossing; shuffling cards or envelopes; throwing dice; drawing of lots; minimisation (minimisation may be implemented without a random element, and this is considered to be equivalent to being random).
	High risk of bias: Sequence generated by odd or even date of birth; date (or day) of admission; sequence generated by hospital or clinic record number; allocation by judgement of the clinician; by preference of the participant; based on the results of a laboratory test or a series of tests; by availability of the intervention.
	Unclear: Insufficient information about the sequence generation process to permit judgement.
Allocation concealment Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment	Low risk of bias: Randomisation method described that would not allow investigator/participant to know or influence intervention group before eligible participant entered in the study (e.g. central allocation, including telephone, web‐based, and pharmacy‐controlled, randomisation; sequentially numbered drug containers of identical appearance; sequentially numbered, opaque, sealed envelopes).
	High risk of bias: Using an open random allocation schedule (e.g. a list of random numbers); assignment envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or non‐opaque or not sequentially numbered); alternation or rotation; date of birth; case record number; any other explicitly unconcealed procedure.
	Unclear: Randomisation stated but no information on method used is available.
Blinding of participants and personnel Performance bias due to knowledge of the allocated interventions by participants and personnel during the study	Low risk of bias: No blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding; blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken.
	High risk of bias: No blinding or incomplete blinding, and the outcome is likely to be influenced by lack of blinding; blinding of key study participants and personnel attempted, but likely that the blinding could have been broken, and the outcome is likely to be influenced by lack of blinding.
	Unclear: Insufficient information to permit judgement
Blinding of outcome assessment Detection bias due to knowledge of the allocated interventions by outcome assessors.	Low risk of bias: No blinding of outcome assessment, but the review authors judge that the outcome measurement is not likely to be influenced by lack of blinding; blinding of outcome assessment ensured, and unlikely that the blinding could have been broken.
	High risk of bias: No blinding of outcome assessment, and the outcome measurement is likely to be influenced by lack of blinding; blinding of outcome assessment, but likely that the blinding could have been broken, and the outcome measurement is likely to be influenced by lack of blinding.
	Unclear: Insufficient information to permit judgement
Incomplete outcome data Attrition bias due to amount, nature or handling of incomplete outcome data.	Low risk of bias: No missing outcome data; reasons for missing outcome data unlikely to be related to true outcome (for survival data, censoring unlikely to be introducing bias); missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups; for dichotomous outcome data, the proportion of missing outcomes compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate; for continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing outcomes not enough to have a clinically relevant impact on observed effect size; missing data have been imputed using appropriate methods.
	High risk of bias: Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups; for dichotomous outcome data, the proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate; for continuous outcome data, plausible effect size (difference in means or standardized difference in means) among missing outcomes enough to induce clinically relevant bias in observed effect size; ‘as‐treated’ analysis done with substantial departure of the intervention received from that assigned at randomisation; potentially inappropriate application of simple imputation.
	Unclear: Insufficient information to permit judgement
Selective reporting Reporting bias due to selective outcome reporting	Low risk of bias: The study protocol is available and all of the study’s pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way; the study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre‐specified (convincing text of this nature may be uncommon).
	High risk of bias: Not all of the study’s pre‐specified primary outcomes have been reported; one or more primary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. sub‐scales) that were not pre‐specified; one or more reported primary outcomes were not pre‐specified (unless clear justification for their reporting is provided, such as an unexpected adverse effect); one or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta‐analysis; the study report fails to include results for a key outcome that would be expected to have been reported for such a study.
	Unclear: Insufficient information to permit judgement
Other bias Bias due to problems not covered elsewhere in the table	Low risk of bias: The study appears to be free of other sources of bias.
	High risk of bias: Had a potential source of bias related to the specific study design used; stopped early due to some data‐dependent process (including a formal‐stopping rule); had extreme baseline imbalance; has been claimed to have been fraudulent; had some other problem.
	Unclear: Insufficient information to assess whether an important risk of bias exists; insufficient rationale or evidence that an identified problem will introduce bias.

Outcome or subgroup title	No. of studies	Statistical method	Effect size
1 Major depression	1	Mean Difference (IV, Random, 95% CI)	Totals not selected
2 Depression	1	Mean Difference (IV, Random, 95% CI)	Totals not selected
3 Health‐related quality of life	1	Mean Difference (IV, Random, 95% CI)	Totals not selected
4 Anxiety	1	Mean Difference (IV, Random, 95% CI)	Totals not selected
5 Stress	1	Mean Difference (IV, Random, 95% CI)	Totals not selected
6 Withdrawal from intervention	1	Risk Ratio (IV, Random, 95% CI)	Totals not selected
7 Hospitalisation	1	Risk Ratio (IV, Random, 95% CI)	Totals not selected

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Depression	3	99	Mean Difference (IV, Random, 95% CI)	‐3.84 [‐6.14, ‐1.54]
2 Health‐related quality of life	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
3 Coping	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
4 Withdrawal from intervention	1		Risk Ratio (IV, Random, 95% CI)	Totals not selected
5 Death (any cause)	2	270	Risk Ratio (IV, Random, 95% CI)	1.69 [0.32, 8.81]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Major depression	3	108	Risk Ratio (IV, Random, 95% CI)	0.47 [0.27, 0.81]
2 Depression (any severity)	3	108	Risk Ratio (IV, Random, 95% CI)	0.69 [0.54, 0.87]
3 Depression	3	108	Mean Difference (IV, Random, 95% CI)	‐7.61 [‐9.59, ‐5.63]
4 Health‐related quality of life	2	64	Mean Difference (IV, Random, 95% CI)	3.06 [2.29, 3.83]
5 Anxiety	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
6 Hospitalisation	1		Risk Ratio (IV, Random, 95% CI)	Totals not selected

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Depression	2	122	Mean Difference (IV, Random, 95% CI)	‐5.77 [‐8.76, ‐2.78]
2 Health‐related quality of life	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
3 Hospitalisation	1		Risk Ratio (IV, Random, 95% CI)	Totals not selected

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Quality of life	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
2 Depression	2	116	Std. Mean Difference (IV, Random, 95% CI)	1.00 [‐3.52, 1.53]
3 Anxiety	1		Mean Difference (IV, Random, 95% CI)	Totals not selected
4 Psychological symptoms	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

Methods	Study design: parallel RCT Time frame: January to April 2017 Follow‐up period: 3 months (7 dialysis session)
Participants	Country: Jordan Setting: multicentre (5) Inclusion criteria: patients undergoing HD; received no antidepressants at the time of enrolment in the study; had diagnosis of CKD and were on chronic dialysis for at least 1 year prior to the study; were able to comprehend and communicate verbally Number (analysed/randomised): treatment group (54/65); control group (51/65) Hamilton score at baseline: treatment group (19.5 ± 5.4); control group (19.6 ± 5.4) Mean age ± SD (years): treatment group (53.4 ± 8.0); control group (52.0 ± 10.7) Sex (M/F): treatment group (not reported); control group (not reported) Antidepressant medication: none of the participant was on antidepressants agents Exclusion criteria: not reported
Interventions	Treatment group CBT Control group Psychoeducation therapy Co‐interventions Not reported
Outcomes	Depression HAM‐D: the scale has 17 multiple choice items to rate the severity of depression in adults. A score from 0 to 7 indicates no depression, 8 to 13 mild depression, 14 to 18 moderate depression, 19 to 22 severe depression, and > 23 very severe depression
Notes	Funding source: none Corresponding author: Faris A. Al saraireh (faa13@case.edu)
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "This study was a randomised clinical trial in which patients were randomly assigned to one of two treatment groups using a random number generator." Comment: Random number generator is considered as low risk of bias
Allocation concealment (selection bias)	Unclear risk	Method of allocation concealment was not reported in sufficient detail to perform an adjudication
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Blinding of participants and/or the investigators was not reported. However, the methods of intervention and control treatment were physically different, and therefore masking of intervention was unlikely
Blinding of outcome assessment (detection bias)   All outcomes	High risk	Quote: "Hamilton depression rating scale was completed by the participants in both groups prior to the therapies and after completion." Comment: The Hamilton depression rating scale was completed by participants before and after interventions. Participants were likely to be aware of the intervention they received. Therefore, the outcome assessment for depression was not blinded
Incomplete outcome data (attrition bias)   All outcomes	High risk	Quote: "Only 130 patients agreed to participate in the study, and were randomly assigned to one of the two groups (N = 65 in each). Of the 130 participants, 14 dropped out from the psychoeducation group and 11 from the CBT group, making the number of participants who completed the study 105 (51 and 54)." Comment: 54/65 in the treatment group and 51/65 in the control group completed the study.
Selective reporting (reporting bias)	High risk	There was no published protocol for this study. This study did not report many patient‐centred outcomes that might be expected for a study of this type (i.e. life participation, fatigue, dialysis withdrawal, adverse events, death)
Other bias	Low risk	No evidence of other sources of bias

Methods	Study design: cross‐over RCT Time frame: not reported Follow‐up period: 6 months
Participants	Country: USA Setting: multicentre (2 dialysis units; Brooklyn, New York) Inclusion criteria: ESKD treatment with HD for at least 6 months and elevated depressive affect (as evidenced on BDI‐II score < 10) Number (analysed/randomised): treatment group (33/38); control group (26/27) Mean age ± SD (years): not reported Sex (M/F): 18/47 Antidepressant medication: only two participants were being treated with antidepressants (whole cohort) Exclusion criteria: Current hospitalisation; altered mental status (Mini‐Mental Status Examination score < 23); psychosis; current substance abuse; current ongoing psychotherapy; a change in psychotropic medication in the last 6 months; lack of English proficiency to participate in talk therapy
Interventions	Treatment group CBT for 3 months Control group Usual care including psychological and psychopharmacological treatment. However, they did not receive any formal CBT as described in intervention protocol for first 3 months Co‐interventions Not reported
Outcomes	Depression BDI‐II: absence of depression (scores of 0 to 9), mild depression (10 to 19), moderate depression (20 to 29), relatively severe depression (30 to 39), and severe depression (40 to 63) DSM‐IV SCID‐ I SCID‐II HAM‐D HRQoL KDQOL‐SF36 Haematological and biochemical data URR Serum albumin SCr IDWG Fluid compliance Comorbid personality disorders Hospitalisation
Notes	Funding Source: supported by the National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases (award number K23DK076980) Corresponding author: D. Cukor (Daniel.Cukor@Downstate.edu)
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Sequence generation methods were not reported in sufficient detail to perform an adjudication
Allocation concealment (selection bias)	Unclear risk	Method of allocation concealment was not reported in sufficient detail to perform an adjudication
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Participants and investigators were not blinded to treatment assignment. As the intervention and comparator were physically different, it was unlikely that participants and investigators were unaware of treatment allocation
Blinding of outcome assessment (detection bias)   All outcomes	Low risk	Quote: "All assessments were conducted by an independent assessor who was blind to the participant’s treatment condition and diagnostic history. [...] The sample’s pretreatment mean scores placed participants in the moderately depressed range, as measured by both clinician administered measures (Hamilton Depression Rating Scale [HAM‐D]; mean 15.2 [SD 6.4]) and self‐report mean depression scores (Beck Depression Inventory II [BDI‐II]; mean 23.3 [SD 9.6])." Comment: The assessor who administered all questionnaires was unaware of the treatment allocation group. Haematological and biochemical data were objective measure of the outcome
Incomplete outcome data (attrition bias)   All outcomes	High risk	As reported in the flow chart, 6/65 participants dropped out (2 spent too many days in hospital, 1 drop out, 1 transplant, 2 switched dialysis centres), 5 from treatment group and 1 from control group. As there was a differential loss between groups that may have related to the intervention or outcome, this bias domain was adjudicated as high risk
Selective reporting (reporting bias)	Low risk	Study reported many outcomes usual for this type of study. Unclear whether outcomes were reported according to pre‐specified protocol
Other bias	Low risk	Study reported statistical methods appropriate for the cross‐over study design. Funding was not involved into the analysis. There were no other apparent sources of bias

Methods	Study design: quasi RCT (cluster randomised uncontrolled trial) Time frame: not reported Follow‐up period: 6 months
Participants	Country: Poland Setting: single centre (Department of Nephrology and Transplantation Medicine in Wroclaw) Inclusion criteria: patients with ESKD, HD therapy for at least 6 months prior to the start of research, patient's informed consent to participate in the study and lack of medical contraindications to exercise training confirmed by physician Number (analysed/randomised): treatment group (20/21); control group (8/16) BDI score at baseline: treatment group (16.1 ± 9.9; data referred to 20 participants); control group (14.0 ± 8.1; data referred to 8 participants) Mean age ± SD (years): treatment group (66.3 ± 13.1; data referred to 20 participants); control group (56.4 ± 13.6; data referred to 8 participants) Sex (M/F): treatment group (9/11; data referred to 20 participants); control group (5/3; data referred to 8 participants) Antidepressant medication: not reported Exclusion criteria: poorly controlled hypertension; severe symptomatic arrhythmia (causing hypotonia); acute coronary syndrome in the last 4 weeks; unstable angina; heart failure (> II in NYHA grading); hyperkalaemia (> 6 mmol/L); hypokalaemia (< 3.5 mmol/L); severe anaemia (HCT < 25%); uncontrolled renal osteodystrophy or osteoporosis confirmed by DEXA; musculoskeletal deformation, acute illness (recent fever, pain/fever of unknown origin)
Interventions	Treatment group Endurance training, 3 times/week for 6 months Control group Resistance training, 3 time/week for 6 months Co‐interventions Not reported
Outcomes	Depression BDI‐II: absence of depression (scores of 0 to 9), mild depression (10 to 19), moderate depression (20 to 29), relatively severe depression (30 to 39), and severe depression (40 to 63) Cognitive‐affective area Somatic problems accompanying mood disorders Anxiety STAI: the criterion for dividing patients into subgroups of low and high level of anxiety for the STAI (X1) was a score of 44, and for STAI (X2) a score of 46. The summed up results for each of the two parts of the questionnaire range from 20 points – mild anxiety, to 80 points – very strong anxiety Change in the depression and anxiety score Death
Notes	Funding Source: grant from National Science Centre Poland. The funding agency had no role in the study design; collection, analysis, and interpretation of data; or the decision to submit this original work for publication Trial registration identification number: not reported Corresponding author: wioletta.dziubek@awf.wroc.pl and Aksamitna1974@wp.pl
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Sequence generation methods were not reported in sufficient detail to perform an adjudication
Allocation concealment (selection bias)	Unclear risk	Method of allocation concealment was not reported in sufficient detail to perform an adjudication
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Blinding of participants and/or the investigators was not reported. The interventions were physically different. Therefore it was unlikely that participants and investigators were blinded to treatment allocation
Blinding of outcome assessment (detection bias)   All outcomes	High risk	Quote: "Each patient filled in a personal questionnaire once at the start of the training, and the Beck Depression Inventory (BDI) and the State‐Trait Anxiety Inventory (STAI) twice, at the start of the training and after 6 months. [...] The questionnaire was self‐administered, however, an assistant was available to answer any questions or explain how to fill in the form." Comment: BDI and the STAI were self‐reported measurements. As such, the outcome assessment was conducted by participants who could be aware of the treatment received. We judged the outcome assessment to be at high risk of bias for these outcome measures
Incomplete outcome data (attrition bias)   All outcomes	High risk	Quote: "A total of 28 patients completed the study." Comment: 1/21 participants in endurance training group and 8/16 in resistance training group were lost to the follow‐up for reasons that appeared unrelated to treatment. There was differential loss between the two groups
Selective reporting (reporting bias)	High risk	This study did not report many patient‐centred outcomes that might be expected for a study of this type (i.e. life participation, fatigue, dialysis withdrawal, adverse events, hospitalisation)
Other bias	Low risk	No evidence of other sources of bias

Methods	Study design: parallel 3 x 3 factorial design RCT Time frame: not reported Follow‐up period: 1 month
Participants	Country: USA Setting: single HD treatment centre (University Hospital at the State University of New York in Stony Brook) Inclusion criteria: in‐centre HD patients who had received HD treatment for at least 5 months Number (analysed/randomised): 41/42 CES‐D score at baseline: treatment group (16.7 ± 3.5); control group 1 (16.8 ± 4.1); control group 2 (15.0 ± 3.6) Mean age: 49.5 years Sex (M/F): 26/16 Antidepressant medication: not reported Exclusion criteria: not English; patients with cognitive impairment
Interventions	Treatment group Strategic self‐presentation: participants presented themselves in a videotaped interview Control group 1 Problem disclosure: participants discussed problems with managing their illness Control group 2 Videotape about adjusting to dialysis Co‐interventions Developed training materials to help beginning patients adjust to their illness
Outcomes	Depression CES‐D: cutoff score of ≥ 16 = depression Physical Psychological Patients' satisfaction Likert‐style scale Patients' perception that questions were representative Likert‐style scale Social desirability and negative affect Marlowe‐Crowne Social Desirability Scale Positive Affect Schedule Negative Affect Schedule
Notes	Funding source: not reported There was no reported registration of the trial within a trial registry, as trial registration was not required in 1999 Corresponding author: R. Friend (rfriend@psych.1.psy.sunysb.edu)
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Blocks of patients were first categorised by sex, months on dialysis and whether they had a comorbid diagnosis of diabetes; there were then randomly assigned to a condition." Comment: Sequence generation methods were not reported in sufficient detail to perform an adjudication
Allocation concealment (selection bias)	Unclear risk	Method of allocation concealment was not reported in sufficient detail to perform an adjudication
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Blinding of participants and/or the investigators was not reported. The methods of intervention and control treatment were physically different. Participants and investigators could be aware on the treatment allocation group
Blinding of outcome assessment (detection bias)   All outcomes	Low risk	Quote: "Patients completed a questionnaire that served as a baseline measure of adjustment. [...] Four female research assistants, who were unaware of the conditions and hypotheses of the study, conducted the interviews. [...] The first author, who was unaware of the condition to which each patient was assigned, administered the questionnaires at the three time points." Comment: The first author administered the questionnaires and he was unaware on the treatment assigned group
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Quote: "Data for the 1‐month post‐treatment assessment were not available for 1 male patient who ceased treatment before the 1‐month assessment." Comment: Overall, 1/42 participants was lost to the follow‐up (< 10% loss to follow‐up, it was not clear if there was a substantial differential loss between groups)
Selective reporting (reporting bias)	High risk	There was no published protocol for this study. This study did not report many patient‐centred outcomes that might be expected for a study of this type (i.e. life participation, fatigue, death, dialysis withdrawal, adverse events)
Other bias	Unclear risk	It was not clear if there was evidence of imbalance at baseline. Not reported in sufficient detail to perform an adjudication

Methods	Study design: parallel RCT 2 x 3 factorial design Time frame: not reported Follow‐up period: 6 weeks
Participants	Country: USA Setting: single centre (outpatient HD centre at the University of Miami School of Medicine/Jackson Memorial Hospital in Miami, Fl) Inclusion criteria: HD patients; at least a minimal English fluency, cognitively capable of proving informed consent Number (analysed/randomised): treatment group (varied/31); control group 1 (varied/31); control group 2 (varied/33) Mean age: 49 years Sex (M/F): 58%/42% Antidepressant medication: not reported Exclusion criteria: not reported
Interventions	Treatment group Christian prayer Control group 1 Positive visualisation Control group 2 Usual care Co‐interventions Not reported
Outcomes	Clinical outcomes Kt/V Albumin Systolic BP Diastolic BP IDWG Serum level of inorganic phosphorus HCT Number of new medical problems since the study began Self‐reported response to the question "Have you been feeling better, the same, or worse since the study began?" HRQoL Health Status Questionnaire Short Form (SF‐36) General health Social functioning Bodily pain Vitality Depression BDI‐II: minimal (scores 0 to 9), mild (scores 10 to 16), moderate (scores 17 to 29), severe (scores 30 to 63) Psychological symptoms Brief Symptom Inventory (BSI) Somatization Depression Anxiety Hostility Believe in prayer or positive visualisation Believe in Prayer/Positive Visualisation Questionnaire Belief in prayer Belief in positive visualisation Level of spirituality and religiosity Hospitalisation
Notes	Number of subjects varied because some subjects were not available at the time of data collection due to their medical condition Funding source: not reported There was no reported registration of the trial within a trial registry, as trial registration was not required in 2001 Corresponding author: W.J. Matthews (shamrock@educ.umass.edu)
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "A volunteer, blinded to the purpose and the hypothesis of the study, randomly assigned each subject to one of the six treatment condition." Comment: Sequence generation methods were not reported in sufficient detail to perform an adjudication
Allocation concealment (selection bias)	Unclear risk	Method of allocation concealment was not reported in sufficient detail to perform an adjudication
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Blinding of participants and/or the investigators was not reported. The methods of intervention and control treatment were physically different. Participants and investigators could be aware on the treatment allocation group
Blinding of outcome assessment (detection bias)   All outcomes	High risk	Quote: "A total of 10 self‐reported dependent measures were analysed." Comment: Laboratory data were considered as objective data. However, all questionnaires were self‐reported measurements. As such, the outcome assessment was conducted by participants who could be aware of the treatment received. We judged the outcome assessment to be at high risk of bias for these outcome measures
Incomplete outcome data (attrition bias)   All outcomes	Unclear risk	As reported in Tables 2 and 3, the number of subjects vary because some subjects were not available at the time of data collection due to their medical condition. The overall number of patients who were lost to the follow‐up and the potential differential loss between groups were unclear
Selective reporting (reporting bias)	High risk	There was no published protocol for this study. This study did not report many patient‐centred outcomes that might be expected for a study of this type (i.e. fatigue, death, dialysis withdrawal, adverse events)
Other bias	Unclear risk	It was not clear if there was evidence of imbalance at baseline. Not reported in sufficient detail to perform an adjudication

Study	Reason for exclusion
Allmann 1990	Wrong intervention/control: this study evaluated the glucose polymer Polycose among people treated with HD (not a psychosocial intervention)
ASCEND 2016	Wrong intervention/control: a psychosocial intervention was compared with a pharmacological intervention
Binik 1993	Wrong population: participants were identified before dialysis was required to preserve their lives
Briggs 2004	Wrong intervention: this study evaluated advanced care planning (not a psychosocial intervention; subject of another Cochrane review)
Burkhalter 2015	Wrong population: kidney transplant recipients more than 1 year post‐transplant
dos Rios Santos 2013	Wrong intervention/control: examined sleep and autonomic sleep function before and after HD (not a psychosocial intervention)
Hosseini 2012	Wrong intervention/control: psychosocial intervention was compared with a pharmacological intervention
IRCT2017020311885N8	Wrong intervention/control: evaluated trans‐cranial stimulation (physical intervention)
Kao 2012	Wrong population: participants with CKD who did not receive dialysis treatment were randomised
NCT1225458	Wrong intervention/control: evaluated additional clinical assessments (not a psychosocial intervention)
Sangill 2006	Wrong intervention/control: evaluated glucose added to the dialysis fluid (not a psychosocial intervention)
SMILE 2010	Wrong intervention/control: evaluated the effects of feedback to renal providers or nurse management of patients to treat symptoms related to ESKD (not psychosocial interventions)
Watson 2015	Wrong population: participants were in pre‐dialysis CKD (stages 3 and 4)
Zhao 2017	Wrong intervention/control: psychosocial intervention was compared with a pharmacological intervention

PERMALINK

Psychosocial interventions for preventing and treating depression in dialysis patients

Patrizia Natale

Suetonia C Palmer

Marinella Ruospo

Valeria M Saglimbene

Kannaiyan S Rabindranath

Giovanni FM Strippoli

Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

Plain language summary

Summary of findings

Background

Description of the condition

Description of the intervention

How the intervention might work

Why it is important to do this review

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Inclusion criteria

Exclusion criteria

Types of interventions

Types of outcome measures

Primary outcomes

Secondary outcomes

Search methods for identification of studies

Electronic searches

Searching other resources

Data collection and analysis

Selection of studies

Data extraction and management

Assessment of risk of bias in included studies

Measures of treatment effect

Dichotomous data

Continuous data

Change scores and missing standard deviations

Unit of analysis issues

Cross‐over studies

Dealing with missing data

Assessment of heterogeneity

Assessment of reporting biases

Data synthesis

Subgroup analysis and investigation of heterogeneity

Sensitivity analysis

'Summary of findings' tables

Results

Description of studies

Results of the search

1.

Included studies

Study design, setting and characteristics

Study participants

Interventions

1. TIDieR framework of interventions descriptions for included studies.

Excluded studies

Ongoing studies

Risk of bias in included studies

2.

3.

Allocation

Blinding

Incomplete outcome data

Selective reporting

Other potential sources of bias

Effects of interventions

Summary of findings for the main comparison. Cognitive‐behavioural therapy versus usual care.

Summary of findings 2. Counselling versus usual care.

Summary of findings 3. Exercise versus usual care.

Summary of findings 4. Relaxation techniques versus usual care.

Summary of findings 5. Spiritual practice versus usual care.

Acupressure versus usual care

Trial name or title	Design and protocol for the Dialysis Optimal Health Program (DOHP) randomised controlled trial
Methods	The study design is a prospective randomised controlled trial. Ninety‐six adult patients initiating HD or PD will be randomly allocated to either the intervention (DOHP) or usual care group.
Participants	Inclusion criteria Diagnosis of near ESKD confirmed by medical records; expected to commence maintenance dialysis for the first time in the next 3 months or commencement of dialysis in the past 3 months; aged 18 or above and able to converse in English without an interpreter; Individuals who are seeking a mental health professional or taking psychotropic medications will be included Exclusion criteria Presence of developmental disability or amnestics syndrome impairing their ability to learn from the intervention; participants returning to dialysis following a failed kidney transplant; and comorbid serious illness as defined by the treating physician
Interventions	Treatment group Participants receiving the intervention will receive nine (8 + 1 booster session) sequential sessions based on a structured information/workbook, psychosocial and educational supports and skills building Control group Usual care
Outcomes	Depression HADS Anxiety HADS HRQoL KDQOL instrument Self‐efficacy General Self‐Efficacy Scale Clinical indices Albumin Haemoglobin
Starting date	March 2015
Contact information	Chantal F. Ski; Email: Chantal.Ski@acu.edu.au.
Notes	Setting: Nephrology unit of St Vincent’s Hospital, Melbourne, Australia. Trial Registration number: ACTRN12615000810516.

Trial name or title	Cognitive‐behavioural (CBT) in ESRD patients with depression
Methods	Patients in HD were divided in CBT group and control group
Participants	Inclusion criteria Patients with ESKD on HD more than 3 months; patients with BDI‐II score ≥ 15 points; adult with age ≥ 20 years old; both genders; patients who were able to understand and willing to sign the written informed consent Exclusion criteria Patients on HD due to AKI; patients who are on admission; undergoing chemotherapy or radiation therapy due to progressive malignant disease; patients who are planning kidney transplantation within few months; with cognitive dysfunction, mental retardation, and drug addict; unavailable for adequate communication with researchers; patients who changed anti‐depressive agent or dose within 2 months before/after the trial.
Interventions	Treatment group 12 sessions of cognitive‐behavioural group therapy in the first 12 weeks Control group Usual care
Outcomes	Depression BDI‐II Hamilton Depression Rating Scale (HAMD‐17) Diagnosis of major depressive disorder (DSM‐IV) Anxiety BAI Stress Perceived Stress Scale HRQoL KDQOL WHO Quality of Life‐BREF (WHOQOL‐BREF) Anxiety BAI Stress Perceived Stress Scale HRQoL KDQOL WHO Quality of Life‐BREF (WHOQOL‐BREF) Temperament and Character Temperament and Character Inventory (TCI) Biomarker related with depression Serotonin Additional anti‐depressant use after trial
Starting date	October 2013
Contact information	C. S. Lim; Email: cslimjy@snu.ac.kr
Notes	Setting: Seoul National University Boramae Hospital, Seoul, Korea. Trial registration number: NCT02011139.

Trial name or title	Mindfulness meditation practice during haemodialysis
Methods	Fifty patients will be randomly separated in two groups, twenty five each group, half of them in the control group and the other half in the intervention group
Participants	Inclusion criteria HD patients of the Einstein Dialysis Center; 18 years to 100 years (adult, senior); both genders Exclusion criteria Participants who refused to signed the informed consent
Interventions	Treatment group The intervention group will be enrolled in the meditation protocol, for 12 weeks, 3 days a week during the HD session Control group The control group will be wait‐listed Then after the evaluations, the control group will receive the intervention of meditation, while the intervention group will not receive any intervention
Outcomes	Depression, stress, QoL, sleep disorders, biochemical parameters Mindful Attention Awareness Scale (MAAS) HRQoL KDQOL Depression BDI Sleep PSQI Stress Perceived Stress Scale (PSS) Depression and stress Self‐Compassion Scale (SCS) Assessment of comorbidities Index of coexistent diseases (ICED)
Starting date	March 2018
Contact information	Erika Bevilaqua Rangel; Email: not reported
Notes	Setting: Hospital Israelita Albert Einstein. Brazil. Trial registration number: NCT03162770

Trial name or title	Decreasing depression and anxiety and their effect on QoL of ESRD patients (end‐stage renal disease) (ESRD)
Methods	Depressed patients with ESKD were randomised to the cognitive‐behavioural intervention and resilience group (intervention group) or cognitive‐behavioural Intervention without resilience
Participants	Inclusion criteria Participants older 18 and younger than 61 years; both genders; depression score in the BDI > 30 points; anxiety score in the BAI > 40 points; have not been hospitalised over the last 6 months; signing of informed consent Exclusion criteria Patients who were not be able to communicate in the Spanish language; presence of psychiatric comorbidity (suicide ideation or depressive or anxious)
Interventions	Treatment group CBT and resilience 8 sessions total, once a week for eight weeks, 2 hours long each, consistent of 6 sessions of CBT plus 2 sessions to improve resilience strengths Control group CBT 8 sessions total, once a week, 2 hours long each. CBT without resilience strengthening
Outcomes	HRQoL KDQOL 36
Starting date	December 2017
Contact information	Cristina Jazmín Gonzalez Flores; Email: crisjaz_10@hotmail.com
Notes	Setting: Hospital Civil de Guadalajara, Jalisco, Mexico. Trial registration number: NCT03330938

Trial name or title	Mindfulness and HEP in dialysis patients with depression and anxiety
Methods	HD patients with depression were randomly assigned in chair‐side mindfulness intervention or Health Enhancement Plan (HEP) group
Participants	Inclusion criteria 18 years to 100 years (adult, senior); both genders; currently receiving maintenance HD; with depression (Patient Health Questionnaire (PHQ‐9) score ≥ 6) and/or anxiety (General Anxiety Disorder‐7 (GAD‐ 7) score ≥ 6); normal cognition or mild cognitive impairment will be addressed on a normal screening result on the 3‐minute Mini‐Cog Test; patients should have sufficient hearing to follow verbal instructions; be able to sit for 20 to 25 minutes without discomfort; have adequate understanding of English and/or French Exclusion criteria Mild, moderate, or severe dementia ("abnormal" result on the 3‐minute Mini‐Cog Test); acute psychotic symptoms; acute suicidal ideation/intent; patients currently receiving active psychotherapy
Interventions	Treatment group Chair‐side mindfulness intervention consists of individually conducted meditative practices, lasting 20 minutes/session, 3 times/week for 8 weeks. The interventions will be conducted during their dialysis sessions. The mindfulness meditation sessions include well‐described meditations such as the body scan (being aware of bodily sensation), gentle arm movements, guided and silent breath meditations Control group Health Enhancement Plan (HEP): meditation‐based intervention trials, controlling for several non‐specific factors found in a mindfulness meditation group. Participants will learn about health promotion, healthy diet, music, exercise as well as implementing positive health‐enhancing life changes both in‐session and during at‐home practice with the support of a group facilitator, but do not learn mindfulness techniques
Outcomes	Depression Patient Health Questionnaire (PHQ‐9) Anxiety General Anxiety Questionnaire (GAD‐7) Stress Perceived Stress Scale (PSS) Perceived Improvement Perceived Improvement Questionnaire (PIQ) Insomnia Athens Insomnia Scale (AIS) HRQoL Patient's assessment on QoL (EuroQOL) Edmonton symptom Edmonton Symptom Assessment Scale (ESAS) Social difficulties Social Difficulties Inventory (SDI) Inflammatory markers Heart rate variability (HRV) Circadian rhythm and sleep quality
Starting date	May 2018
Contact information	Marouane Nassim; Email: marouane.nassim@mail.mcgill.ca
Notes	Setting: McGill University Health Center, Toronto. Trial registration number: NCT03406845.

Trial name or title	Protocol of a mixed method, randomised controlled study to assess the efficacy of a psychosocial intervention to reduce fatigue in patients with End‐stage renal disease (ESRD)
Methods	This study follows a mixed‐methods design in which both quantitative and qualitative data will be collected. A multi‐centre, RCT with repeated measures will be conducted to quantitatively assess the efficacy of the psychosocial intervention in reducing fatigue and improving QoL in ESKD patients. Additional secondary outcomes and medical parameters will be assessed. Outcomes will be compared to patients receiving usual care. A sample of 74 severely fatigued dialysis patients will be recruited from 10 dialysis centres. Patients will be randomly assigned to the intervention or control group. Outcomes will be assessed at baseline, post intervention/16 weeks, and at three and six‐month follow‐ups. A qualitative process evaluation will be conducted parallel to/following the effectiveness RCT. Interviews and focus groups will be conducted to gain insight into patients’ and social workers’ perspectives on outcomes and implementation procedures. Implementation fidelity will be assessed by audio‐taped and written registrations. Participatory methods ensure the continuous input of experiential knowledge, improving the quality of study procedures and the applicability of outcomes.
Participants	Inclusion criteria Adult patients (age ≥ 18 years), male or female, who undergo day dialysis (HD), PD, at home, a hospital or a dialysis centre); experiencing (severe) fatigue (score CIS‐fatigue scale ≥ 35); being able to walk/move for at least 10 min with or without a supporting device such as a walking stick; having a sufficient understanding of the Dutch language in order to participate in counselling, (group) interviews and fill out the questionnaires adequately Exclusion criteria Dialysis during the night (since it is assumed that patients on day dialysis experience more severe fatigue compared to patients on night dialysis); participation in other studies or treatments aimed at reducing fatigue; treatment by a psychologist or psychiatrist (for severe psychiatric problems such as depression, psychosis, personality disorders or schizophrenia); alcohol or drug addiction.
Interventions	Treatment group Usual treatment and psychosocial counselling by a social worker in the dialysis department, for 16 weeks Control group Usual care
Outcomes	Fatigue Checklist Individual Strength (CIS‐fatigue) HRQoL Quality of life Kidney Disease and Quality of Life Short Form (KDQOL‐SF) Social support Social Support Inventory (SSL‐I + SSL‐D) Subscale Utrechtse Coping Lijst (UCL) Illness cognitions Illness Cognition Questionnaire (ICQ) Illness perceptions Illness Perception Questionnaire (IPQ‐R) Coping Cognitive Emotion Regulation Questionnaire (CERQ) Catastrophizing thoughts Fatigue Catastrophizing Scale (J‐FCS) Mastery Mastery Scale Depression Depression Patient Health Questionnaire (PHQ‐9)
Starting date	Not reported
Contact information	W. van der Borg; Email: w.vanderborg@vumc.nl
Notes	Setting: Department of Medical Humanities, VU University Medical Center/EMGO, Amsterdam, The Netherlands. Trial registration number: NTR5366

Trial name or title	Wellbeing intervention for chronic kidney disease (WICKD): a randomised controlled trial study protocol
Methods	This is a 3‐arm, wait list, single‐blind randomised controlled trial testing the efficacy of the Stay Strong App in improving psychological distress, depressive symptoms, QoL and treatment adherence among Indigenous clients undergoing HD in Alice Springs and Darwin with follow‐up over two periods of 3 months (total of 6 months observation). The study compares the efficacy of MCP using the AIMhi Stay Strong App with two control groups (control app intervention and treatment as usual).
Participants	Inclusion criteria Aboriginal and/or Torres Strait Islander person and aged ≥18 years, currently receiving maintenance HD in Alice Springs or Darwin and having been receiving this treatment for more than 6 months Exclusion criteria < 18 years, guardianship order in place, or unable to give informed consent (e.g. cognitively or visually impaired)
Interventions	Treatment group Early treatment with motivational care planning (MCP) using the Stay Strong App (62 participants); participants received MCP at baseline Control group 1 Contact control/delayed treatment with the Stay Strong App (62 participants); participants received MCP after 3 months Control group 2 Treatment as usual/delayed treatment with the Stay Strong App (32 participants) (usual care)
Outcomes	Psychological distress The Kessler Distress Scale (K10) Depression The adapted Patient Health Questionnaire (PHQ‐9) QoL The EuroQoL instrument (EQ‐5D) Mobility Self‐care Usual activities Pain and discomfort Anxiety and depression Adherence to dialysis treatment planning through file audit Cost effectiveness Costs of dialysis Costs of inpatient hospitalisations ED presentations Estimation of outpatient health care use
Starting date	February 2017
Contact information	Kylie M. Dingwall; kylie.dingwall@menzies.edu.au
Notes	Protocol. Setting: Alice Springs and Charles Darwin University, Australia. Trial registration number: ACTRN12617000249358