Erdley 2014.

Methods	Study design: parallel RCT Time frame: recruitment from 1 January 2012 to 31 January 2012; trial was initiated on 1 February 2012 and ended on 1 May 2012 Follow‐up period: 6 weeks
Participants	Country: USA Setting: single centre (Geisinger Medical Center outpatient dialysis unit) Inclusion criteria: (1) had been diagnosed with ESKD; (2) currently receiving outpatient HD at Geisinger Medical Center at a minimum of 3 months; (3) ≥ 60 years; (4) consented to allow the research team to access disease‐severity indicators from their medical records; and (5) consented to receiving 6 weeks of Problem‐Solving Therapy or usual care, combined with a follow‐up 60‐minute qualitative interview Number (analysed/randomised): treatment group (15/17); control group (18/18) Mean age ± SD (years): treatment group (72.2 ± 5.6); control group (75.3 ± 8.28) Sex (M/F): treatment group (10/5); control group (11/7) Antidepressant medication: sertraline, lorazepam, citalopram Exclusion criteria: chart diagnosis of cognitive disorder, dementia or Alzheimer‐related diseases; psychotic disorder, or mild cognitive impairment; already receiving psychological counselling
Interventions	Treatment group Problem‐solving therapy; 6 weekly sessions Control group Usual care 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) Patient Health Questionnaire‐9 (PHQ‐9) (cutoff at least 10 = depression) Changes in HRQoL KDQOL‐SF36 Mental component summary Physical component summary Problem‐solving ability Jaloweic Coping Scale (JCS) Confrontive Evasive Optimistic Fatalistic Palliative Supportant Reliant Emotive Social Problem Solving Inventory, Revised Short Form (SPSI‐R) Positive problem orientation Negative problem orientation Rational problem solving Impulsivity/Carelessness style Avoidance style Death (all causes) Withdrawal from the intervention
Notes	Funding Source: not reported Trial registration identification number: not reported Corresponding author: S. Erdley (shiloherdley@yahoo.com)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The actual treatment condition given to an in‐centre dialysis patient was determined by a random scheme produced by computer software that incorporated a standard procedure for generating random numbers with an allocation ratio of 1:1—that is, to either the Problem‐Solving Therapy + usual care group (n=15) or the usual care only control group (n = 18)." Comment: The computer generation is considered a low risk of bias
Allocation concealment (selection bias)	Unclear risk	Quote: "The generation of the allocation sequence and the assignment of participants were performed by the Haemodialysis Center secretary." Comment: 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	Quote: "This pilot study used an unblinded design, and participants were informed of their allocation sequence upon completing their baseline measures." Comment: The methods of intervention and control treatment were physically different, participants and investigators were aware on the treatment allocation group
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "The Beck Depression Inventory (BDI) was used to measure depressive symptoms. The Beck Depression Inventory (BDI) is a 21‐item self‐administered questionnaire. [...] The Patient‐Health Questionnaire (PHQ‐9) was used to measure depressive symptoms. The Patient‐Health Questionnaire (PHQ‐9) is a self‐administered version. [...] Secondary outcomes of health related quality of life were assessed by means of the Kidney Disease Quality of Life (KDQOL‐36). [...] The Jaloweic Coping Scale (JCS) was used to measure individual coping skills ability. [...] The Social Problem Solving Inventory, Revised Short Form (SPSI‐R) was used to examine subject‐perceived social‐problem ability across 5 dimensions. The Social Problem Solving Inventory, Revised Short Form (SPSI‐R) is a 25‐item self‐report measure." Comment: The BDI, the Patient‐Health Questionnaire (PHQ‐9) and the Social Problem Solving Inventory, Revised Short Form (SPSI‐R) were completed by participants. Participants were aware of the intervention they received. Therefore, the outcome assessment for depression and social problem solving was not blinded. It was not reported who completed the quality of life assessment measure. Therefore it was unclear whether the completion of this outcome was blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Figure 3 shows numbers of recruitment, exclusions, refusal, and dropouts throughout the study. Post randomisation, one participant in the intervention group withdrew due to illness and a second participant died shortly after completing pretest measures." Comment: 2/17 in the intervention group and 0/18 in the control group were lost to the follow‐up for reasons that appeared unrelated to treatment
Selective reporting (reporting bias)	Low risk	There was no published protocol for this study. This study report many patient‐centred outcomes that might be expected for a study of this type
Other bias	Low risk	No evidence of other sources of bias