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. 2017 Sep 5;2017(9):CD012791. doi: 10.1002/14651858.CD012791

Mindfulness‐based stress reduction for family carers of people with dementia

Zheng Liu 1,✉, Yu‐Ying Sun 2, Bao‐liang Zhong 1
PMCID: PMC6483693

Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To assess the benefits and harms of MBSR for family carers of people with dementia.

Background

Description of the condition

Dementia has become a public health priority due to the ageing population. Approximately 46.8 million people are estimated to live with dementia globally, in low‐ to high‐income regions, and the figure increases by 9.9 million annually (Prince 2015). Dementia leads to progressive cognitive deficits, functional impairment and behavioural changes. Over time, people with dementia become unable to function independently and require increasing amounts of care from others. Such care lasts for a median of 6.5 years and is most often provided by family members of the person with dementia (Haley 1997).

Caring for relatives with dementia is highly challenging. Indeed, family carers of people with dementia are vulnerable to a range of physical and psychological morbidities, including cardiovascular diseases (Mausbach 2007), depression, anxiety (Cooper 2007; Cuijpers 2005), and even early mortality (Schulz 1999). These and other issues may negatively influence carers' quality of life (Thomas 2006). Carers who feel overburdened are likely to institutionalise people with dementia at an earlier stage, putting pressure on the public healthcare budget (Spijker 2008). Therefore, there is a great need to help family carers of people with dementia to cope with the stress they encounter.

Various psychosocial interventions have been developed for family carers of people with dementia (Acton 2001; Peacock 2003; Pinquart 2006; Selwood 2007; Sörensen 2002). These interventions often include a number of components and aim variously to provide knowledge, practical skills (e.g. behaviour management or communication skills), social support and stress reduction. Their efficacy in reducing the distress felt by family carers is generally mild to moderate (Acton 2001; Peacock 2003; Pinquart 2006; Selwood 2007; Sörensen 2002). Furthermore, no matter how skilful or competent carers are, they are highly likely to experience stress and to feel overwhelmed at times in real‐life situations. This is where the skills of mindfulness may come in, allowing carers to relate to the challenges they face in new ways (Kabat‐Zinn 2013).

Description of the intervention

Mindfulness is described as "the awareness that emerges through paying attention on purpose, in the present moment, and non‐judgmentally to the unfolding of experience" (Kabat‐Zinn 2013). Mindfulness‐based stress reduction (MBSR) is a widely used mindfulness‐based intervention involving a range of mindfulness practices with a focus on stress reduction or pain relief (Kabat‐Zinn 2013). The mindfulness practices in MBSR often include meditations, body scanning and yoga. The MBSR programme might be slightly adapted for the study population to accommodate their physical limitations or time commitment, or both (Brown 2016; Oken 2010).

How the intervention might work

Among people caring for a relative with dementia, it is common to worry and ruminate over past events or over an uncontrollable future related to the progression of the illness. Worry and rumination are closely related to the distress felt by carers of people with dementia. By a relatively intensive mindfulness training in MBSR, the carers of people with dementia can learn to be present with the difficulties they face, and to accept unconditionally their own emotions and thoughts (which may be distressing or dysfunctional). This process of present‐moment awareness and non‐judgmental acceptance has been reported to reduce worry and rumination (Borders 2010; Jain 2007).

MBSR has shown promising benefits in clinical and non‐clinical populations, including, among others, people facing chronic pain, coping with cancer or parenting children with autism (Baer 2003; Grossman 2004; Keng 2011). The positive effects across various samples indicate that mindfulness training might enhance the ability to cope with stress even in extraordinary circumstances, such as dementia caring (Oken 2010; Whitebird 2013).

Why it is important to do this review

The amount of research on MBSR for carers of people with dementia has increased in recent years (Brown 2016; Oken 2010; Whitebird 2013). It is important to conduct a systematic review and meta‐analysis to synthesise the evidence. Previous reviews on a similar topic did not use such a systematic approach, including use of a systematic search strategy (Hurley 2014), did not provide a quantitative synthesis of included studies using meta‐analytic techniques (Hurley 2014; Jaffray 2015; Li 2016), or did not focus specifically on the population of family carers of people with dementia (Dharmawardene 2016; Jaffray 2015; Li 2016). Our review will comprehensively search the published and unpublished literature, and will quantitatively evaluate the evidence for MBSR for family carers of people with dementia.

Objectives

To assess the benefits and harms of MBSR for family carers of people with dementia.

Methods

Criteria for considering studies for this review

Types of studies

We will include individually randomised, parallel‐group controlled trials. We will not consider cluster‐randomised or cross‐over trials.

Types of participants

The participants will be family carers taking care of people with any type of dementia living in the community. The relationship of family carers to people with dementia could be spouses, children, other family members, friends or neighbours. We will not consider care workers who provide care to people with dementia as a paid job.

Types of interventions

We will include MBSR (Kabat‐Zinn 2013), both in its original or adapted versions (Description of the intervention). We will apply no restrictions to the 'dosage' (i.e. the number or length of individual sessions or the duration of the trials). We will include interventions delivered to groups or individuals, or using a mixture of these two approaches. We will include face‐to‐face, telephone‐based, Internet‐based or other delivery methods.

Acceptable comparators will be active controls, waiting list controls or usual care controls. Specifically, active controls refer to interventions matched in time and attention with MBSR, with the aim to control for the non‐specific effects of MBSR programmes (such as contact with researchers or social support from other participants). Participants in waiting list controls will have the opportunity to receive MBSR after waiting for some time. Participants in usual care controls will get the form of support usually available in their community.

Types of outcome measures

We will include outcomes measured at the end of the intervention period and at later follow‐ups.

Primary outcomes

  1. Depressive symptoms of carers measured with any psychometrically valid and reliable tool, such as the Centre for Epidemiological Studies Depression scale (CES‐D; Radloff 1977), the Brief Symptom Inventory (BSI; Boulet 1991), the Hospital Anxiety and Depression Scale (HADS; Zigmond 1983), the Hamilton Depression Rating Scale (HDRS; Hamilton 1960), and the Geriatric Depression Scale (GDS; Yesavage 1983).

Secondary outcomes

For carers:

  1. anxiety measured by any psychometrically valid and reliable tool, such as the State‐Trait Anxiety Inventory (STAI; Spielberger 1983), HADS (Zigmond 1983), BSI (Boulet 1991), the Hamilton Anxiety Scale (HAMA; Hamilton 1959), and the Hopkins Symptom Checklist (HSCL; Derogatis 1974);

  2. carer burden assessed by any psychometrically valid and reliable tool, such as the Zarit Burden Interview (ZBI; Zarit 1980), and the Caregiver Appraisal Tool (CAT; Lawton 1989);

  3. coping style measured with the Ways of Coping Checklist‐Revised (WCCL‐R; Vitaliano 1985), the Ways of Coping scale (Moos 1992), or similar validated scales;

  4. quality of life assessed by any psychometrically valid and reliable tool;

  5. dropout rates assessed by the percentages of participants discontinuing the interventions.

We anticipate that adverse events will be variously described by the studies included, and may be evident primarily as negative changes in the other outcomes mentioned above. Therefore, we present no particular adverse events outcome. We will describe any adverse events reported by the included studies under 'Characteristics of studies' in the full review.

For people with dementia:

  1. quality of life measured by any psychometrically valid and reliable tool designed for people with dementia, such as the Alzheimer's Disease Related Quality of Life scale (ADRQL; Rabins 1999);

  2. institutionalisation. We will assess both the odds of institutionalisation and time to institutionalisation (Spijker 2008).

Search methods for identification of studies

We will identify the trials by searching electronic databases and other resources.

Electronic searches

We will search ALOIS (www.medicine.ox.ac.uk/alois) ‐ the Cochrane Dementia and Cognitive Improvement Group's (CDCIG) specialised register. ALOIS is maintained by the Information Specialists for the CDCIG, and contains studies that fall within the areas of dementia and cognitive improvement. The studies are identified through:

  1. monthly searches of a number of major healthcare databases: MEDLINE, Embase, CINAHL, PsycINFO and LILACS;

  2. monthly searches of a number of trial registers: ISRCTN, UMIN (Japan's Trial Register), World Health Organization (WHO) portal (which covers ClinicalTrials.gov, ISRCTN, Chinese Clinical Trials Register, German Clinical Trials Register, Iranian Registry of Clinical Trials and Netherlands National Trials Register, plus others);

  3. quarterly search of The Cochrane Library's Central Register of Controlled Trials (CENTRAL);

  4. six‐monthly searches of a number of grey literature sources: ISI Web of Knowledge Conference Proceedings, Index to Theses and Australasian Digital Theses.

We will run additional searches in MEDLINE, Embase, PsycINFO, CINAHL, ClinicalTrials.gov and the WHO Portal/ICTRP to ensure that the searches are as comprehensive and up‐to‐date as possible.

We will not restrict our search to any language, and if necessary, will get trial reports translated. The search strategy that will be used for the retrieval of reports of trials from MEDLINE (via the OvidSP platform) can be seen in Appendix 1.

Searching other resources

We will check the reference lists of all relevant studies to identify more trials (Baer 2003; Dharmawardene 2016; Grossman 2004; Hurley 2014; Jaffray 2015; Li 2016). We will seek unpublished data by contacting researchers and other people with an interest in the field. Where possible, we will contact the corresponding authors of identified randomised controlled trials for additional information about other relevant studies. There will be no language restriction.

Data collection and analysis

We will use Review Manager 5 for Mac to conduct data entry and calculation of effect sizes (RevMan 2014), and Stata/SE version 14.1 for Mac to conduct investigation of heterogeneity and publication bias, subgroup, meta‐regression and sensitivity analyses.

Selection of studies

Two review authors (ZL; YYS) will independently select studies in two stages. First, we will screen the titles and abstracts of citations obtained by the searches. Second, we will obtain the full texts of potentially eligible studies to identify whether studies fulfil the inclusion criteria. We will resolve any disagreement by discussion or by consulting a third review author (BLZ). We will list the studies excluded at the full‐text stage and the detailed reasons for their exclusion in the 'Characteristics of excluded studies' table.

Data extraction and management

Two review authors (ZL; YYS) will independently extract data based on the recommended items from the Cochrane Handbook for Systematic Reviews of Interventions (Section 7.3.1; Higgins 2011a). The collected information will include the authors; publication date; country; funding source; study design; eligibility criteria; characteristics of the study population (including age, gender and relationship to person with dementia); characteristics of interventions (sessions, dosage, duration, mode of delivery); types and contents of comparators; outcomes and results. For results, we will collect outcome measures used, time of assessment and statistics (numbers of participants, means, standard deviations or other summary statistics). We will resolve any disagreements by discussion or consulting a third review author (BLZ). If important information is unreported, we will contact the original investigators for the missing information. We will present the information in the 'Characteristics of included studies' table.

Assessment of risk of bias in included studies

Two review authors (ZL; YYS) will independently assess the risk of bias of included studies by following Cochrane guidance (Higgins 2011b). The sources of bias will include: selection bias, performance bias, detection bias, attrition bias and reporting bias. Regarding selection bias, we will assess random sequence generation, allocation concealment and comparability of baseline characteristics between groups. Concerning detection bias, we will judge whether outcome assessors were blinded to allocation. With regards to attrition bias, we will appraise the comparability of carer characteristics between the completers and the dropouts and the methods used by the study to deal with missing data, including whether or not there was an intention‐to‐treat analysis. In terms of reporting bias, we will search for protocols of included trials, and then determine if the outcomes listed in the protocols were all reported in the trials. Although it is not possible to blind personnel or participants (or both) to psychosocial interventions of this nature, we will nevertheless make judgements about the potential influence of performance bias on treatment effects. For instance, performance bias may be less of a concern for interventions delivered via the Internet than those delivered in a face‐to‐face format. We will rate the risk of bias in each domain as 'high risk,' 'unclear risk' or 'low risk' according to the Cochrane standards (Higgins 2011b). In case of any disagreement, we will resolve it by discussion or consulting a third review author (BLZ). We will request missing information related to the risk of bias assessment from the original investigators.

We will include all studies in the initial analyses. We will exclude studies assessed as being at high risk of selection, detection or attrition bias in sensitivity analyses as described under Sensitivity analysis.

Measures of treatment effect

For dichotomous data, we will use the risk ratio (RR) as the measure of treatment effect with its 95% confidence interval (CI). For continuous data, we will calculate the standardised mean difference (SMD) if trials used different psychometric scales, or the mean difference (MD) if trials used the same scale, with 95% CIs. If possible, we will use immediate postintervention values to calculate the main treatment effect.

Unit of analysis issues

The person allocated to the comparison groups in the included trials will be the unit of analysis.

Dealing with missing data

We will evaluate the missing data and dropout rates for each included trial, and we will display the results in the full review. If necessary, we will request the missing data from the original investigators. We will prefer intention‐to‐treat analyses from the included studies for meta‐analysis. We will report any imputation methods used in the original studies.

Assessment of heterogeneity

We will assess clinical or methodological variation across studies by comparing important characteristics of interventions (e.g. duration, intensity), participants (e.g. age, gender) and the comparisons (whether the control groups were active or inactive).

We will assess statistical heterogeneity by visual inspection of forest plots, test of significant level (P value) and the I2 statistic. The level of heterogeneity across studies will be rated as low (I2 = 25%), moderate (I2 = 50%) or high (I2 = 75%) (Higgins 2003). The methods we will employ to investigate heterogeneity include sensitivity, subgroup and meta‐regression analyses (a detailed description is given in Subgroup analysis and investigation of heterogeneity).

Assessment of reporting biases

We will assess the possibility of reporting biases, including publication bias, by drawing funnel plots (Egger 1997; Sterne 2011). We recognise that asymmetry of funnel plots can be due to publication bias or a genuine relationship between effect size and trial size. We will examine clinical or methodological variation of the included studies to investigate asymmetry, and in addition, compare results obtained from published reports with results from other sources. There will be a minimum of 10 studies required for the meaningful interpretation of funnel plots.

Data synthesis

As we expect a considerable amount of clinical heterogeneity across included studies, we will use the random‐effects model to pool the results by inverse variance methods. If meta‐analysis is not appropriate, because of a lack of essential data, or because of marked heterogeneity of included studies (e.g. opposite directions of effect), we will present findings of these studies narratively. Our main analyses will be at the end of treatment. If studies assessed for persistence of intervention effects with post‐treatment follow‐ups, we will conduct separate analyses for outcomes measured within three months, three to six months and six months to one year from the end of treatment.

Subgroup analysis and investigation of heterogeneity

If we identify moderate or high levels of heterogeneity in the meta‐analysis, we will consider carefully the following characteristics as potential effect modifiers:

  1. nature and dose of the active intervention;

  2. nature of the control intervention;

  3. levels of carers' depressive symptoms at baseline;

  4. levels of carer burden at baseline.

If there are sufficient studies, we will consider conducting subgroup analyses based on these potential effect modifiers.

Sensitivity analysis

We will conduct sensitivity analyses for the following considerations.

  1. To investigate heterogeneity, we will exclude any individual studies for which the 95% CI of the treatment effect does not overlap with others.

  2. We will compare the pooled results obtained by excluding individual studies at high risk of selection, detection or attrition bias, as described in Assessment of risk of bias in included studies.

Presentation of results: GRADE and 'Summary of findings' tables

We will use GRADE methods to rate the quality of the evidence (high, moderate, low or very low) behind each effect estimate in the review (Guyatt 2011). This rating refers to our level of confidence that the estimate reflects the true effect, taking into account the risk of bias in the included studies, inconsistency between studies, imprecision in the effect estimate, indirectness in addressing our review question and the risk of publication bias. We will produce 'Summary of findings' tables for the following comparisons: mindfulness‐based stress reduction versus controls for family carers of people with dementia, including the following outcomes:

  1. depressive symptoms of carers;

  2. anxiety of carers;

  3. carer burden;

  4. dropout rates;

  5. institutionalisation.

Acknowledgements

We would like to thank the following people from the Department of Psychiatry, the Chinese University of Hong Kong: Prof Linda Chiu‐Wa Lam, Prof Sing Lee and Prof Arthur Dun‐Ping Mak for their patient guidance and continuous support throughout the period of study design.

Appendices

Appendix 1. MEDLINE search strategy

1 Dementia/

2 Delirium/

3 Wernicke Encephalopathy/

4 Delirium, Dementia, Amnestic, Cognitive Disorders/

5 ("benign senescent forgetfulness" or ("normal pressure hydrocephalus" and "shunt*") or ("organic brain disease" or "organic brain syndrome") or ((cerebral* or cerebrovascular or cerebro‐vascular) adj2 insufficien*) or (cerebr* adj2 deteriorat*) or (chronic adj2 (cerebrovascular or cerebro‐vascular)) or (creutzfeldt or jcd or cjd) or (lewy* adj2 bod*) or (pick* adj2 disease) or alzheimer* or binswanger* or deliri* or dement* or huntington* or korsako*).tw.

6 OR/1‐5

7 Caregivers/

8 (caregiver* or care‐giver* or "care giver*" or carer* or daughter* or dependents or families* or family* or folk* or kinship or parent* or relatives or spouse* or wife* or wives* or husband*).ti,ab.

9 OR/7‐8

10 exp Mindfulness/

11 MBSR.ti,ab.

12 mindful*.ti,ab.

13 "mindful*".ti,ab.

14 meditation/

15 meditat*.ti,ab.

16 OR/10‐15

17. randomized controlled trial.pt.

18. controlled clinical trial.pt.

19. randomized.ab.

20. placebo.ab.

21. drug therapy.fs.

22. randomly.ab.

23. trial.ab.

24. groups.ab.

25 OR/17‐24

26 6 AND 9 AND 16 AND 25

Contributions of authors

ZL: designed the study and wrote the protocol.

YYS and BLZ: collaborated with the study design.

Sources of support

Internal sources

  • Department of Psychiatry, the Chinese University of Hong Kong, China.

  • Peking University School of Public health, China.

External sources

  • No sources of support supplied

Declarations of interest

None.

New

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