Behavioural activation written self-help to improve mood, wellbeing and quality of life in people with dementia supported by informal carers (PROMOTE): a study protocol for a single-arm feasibility study

Abstract

BackgroundIncreases in life expectancy have resulted in a global rise in dementia prevalence. Dementia is associated with poor wellbeing, low quality of life and increased incidence of mental health difficulties such as low mood or depression. However, currently, there is limited access to evidence-based psychological interventions for people with dementia experiencing low mood and poor wellbeing. Behavioural activation-based self-help, supported by informal carers and guided by mental health professionals, may represent an effective and acceptable solution.Methods/designThe present study is a phase II (feasibility) single-arm trial informed by the Medical Research Council complex interventions research methods framework. Up to 50 dementia participant/informal carer dyads will be recruited from a variety of settings including primary care, dementia-specific health settings and community outreach. People living with dementia will receive behavioural activation-based self-help and be supported by their informal carer who has received training in the skills required to support the self-help approach. In turn, during the use of the intervention, the informal carer will be guided by mental health professionals to help them work through the materials and problem solve any difficulties. Consistent with the objectives of feasibility studies, outcomes relating to recruitment from different settings, employment of different recruitment methods, attrition, data collection procedures, clinical delivery and acceptability of the intervention will be examined. Clinical outcomes for people with dementia (symptoms of depression and quality of life) and informal carers (symptoms of depression and anxiety, carer burden and quality of life) will be measured pre-treatment and at 3 months post-treatment allocation.DiscussionThis study will examine the feasibility and acceptability of a novel behavioural activation-based self-help intervention designed to promote wellbeing and improve low mood in people living with dementia, alongside methodological and procedural uncertainties associated with research-related procedures. As determined by pre-specified progression criteria, if research procedures and the new intervention demonstrate feasibility and acceptability, results will then be used to inform the design of a pilot randomised controlled trial (RCT) to specifically examine remaining methodological uncertainties associated with recruitment into a randomised controlled design.Trial registrationCurrent Controlled Trials ISRCTN42017211

Opt-out rates and reasons for non-participation in a single-arm feasibility trial (ENGAGE) of a guided internet-administered CBT-based intervention for parents of children treated for cancer: a nested cross-sectional survey

“…Parents were asked a closed, multiple-choice question regarding reasons for non-participation, reasons were informed by previous research,42 43 and parents could select all applicable reasons: (1) lack of time; (2) physical health; (3) not wanting to participate in research; (4) not liking to talk about personal problems; (5) too tired; (6) not interested in internet-administered self-help; (7) no need for psychological support; (8) child’s health condition and (9) child has recently passed away. The open question at the end of the reasons for non-participation questionnaire was: ‘If you do not want to participate in the project for reasons other than those mentioned above, please write these below’.…”

Behavioural activation therapy for post-stroke depression: the BEADS feasibility RCT

“…In addition, reduced resource use suggested potential cost-effectiveness. 50 The transferability of BA to hard-to-reach populations, such as those with aphasia and severe cognitive problems, [51][52][53][54] adds to its potential as a psychological intervention for depression after stroke. Given that the CALM trial 17 demonstrated that it was possible to deliver BA to stroke survivors with aphasia and that studies of BA in people with dementia indicate that it is suitable for those with cognitive impairment, 54 there is significant potential for using BA for treating depression in stroke survivors with mild to moderate communication and cognitive impairment.…”

Supported cognitive-behavioural therapy self-help versus treatment-as-usual for depressed informal caregivers of stroke survivors (CEDArS): feasibility randomised controlled trial

“…Indeed, a review of interventions for informal caregivers of stroke survivors recommended telephone or internet-administered support to increase access for this population (Bakas et al, 2014). However, evidence indicates that adapting LICBT interventions to represent the needs of specific populations is required to improve acceptability and engagement with adaptations made to interventions for Armed Forces veterans (Farrand et al, 2019), people with dementia (Farrand et al, 2016) and parents of children treated for cancer (Wikman et al, 2018). Failing to adapt LICBT interventions for specific populations may also account for smaller effect sizes experienced by people with chronic health conditions compared with an adult mental health population (Beatty and Lambert, 2013;Farrand and Woodford, 2015), whereas tailoring psychological interventions for informal caregivers resulted in interventions being more effective than non-tailored interventions (Bakas et al, 2014).…”