Behavioural Activation (BeatIt) for Depression in Adults With Severe Intellectual Disabilities. A Feasibility Randomised Controlled Study of BeatIt Versus Treatment as Usual
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change from baseline on the Mood, Interest and Pleasure Questionnaire (MIPQ) at 24 weeks
Study Overview
Brief Summary
Depression is common, but no psychological interventions have been tested to see if they work for adults with severe intellectual disabilities. The research team recently successfully completed a full-scale trial of a psychological intervention, BeatIt, for depressed adults with mild/moderate intellectual disabilities. The aim of this study is to comprehensively evaluate the feasibility of modifying BeatIt for depressed adults with severe intellectual disabilities, collecting the information needed on likely recruitment, measures, and waiting list control arm options, to design a full-scale study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Severe/profound intellectual disabilities
- •18 years old and over
- •Clinically significant unipolar depression
- •Has a family member or paid carer who has supported them for a minimum of 6 months to complete the screening and baseline visits OR is able to obtain information for the previous 4 months prior to randomisation. The carer, or another named individual, should be available for weekly-fortnightly treatment sessions with the practitioner, and should currently provide a minimum of 10 hours support per week to the participant.
Exclusion Criteria
- •Mild/moderate intellectual disabilities
- •Factors that prevent the person from interacting with the carer and therapist or retaining information from the therapy (e.g. late stage dementia, significant agitation, withdrawal arising from psychosis)
- •Does not consent to her/his GP being contacted about their participation in the study.
Arms & Interventions
Behavioural activation
The treatment is designed to be delivered to individuals alongside a carer who provides regular support to them. It is a structured, time limited, manualised psychological therapy, developed to treat those with an intellectual disability and depressive symptoms.
Intervention: Behavioural Activation (Behavioral)
Treatment as usual
This will include the existing treatments available in NHS and social care for adults with intellectual disability with depression, including anti-depressants, mood stabilizers, and any available psychological interventions. Additionally, for all those in the study, we will provide their General Practitioner with a summary of the NICE guidelines on treatment of depression for adults with intellectual disabilities.
Outcomes
Primary Outcomes
Change from baseline on the Mood, Interest and Pleasure Questionnaire (MIPQ) at 24 weeks
Time Frame: Baseline and week 24
A measure of the individuals mood and engagement in activities. The score range for each sub-scale is 0 - 24. Total score range is 0 - 48. Lower scores indicate lower mood and lower levels of interest and pleasure (within the last 2 week)
Change from baseline on Intellectual Disabilities Depression Scale (IDDS) at 24 weeks
Time Frame: Baseline and week 24
This is a 38-item behavioural checklist derived from DSM-III-R criteria, designed to measure the frequency of identified depressive behaviours within a four-week period. Each item is scored on a 7-point Likert scale from 0 (never) to 6 (always). All scores are summed to provide a total score, ranging from 0 to 228. Higher scores indicate a higher frequency of depressive symptoms.
Secondary Outcomes
- Change from baseline on the Anxiety, Depression and Mood Scale at 24 weeks(Baseline and week 24)
- Change from baseline on the Modified Index of Community Involvement (ICI) at 24 weeks(Baseline and week 24)
- Change from baseline on the Modified Index of Domestic Participation at 24 weeks(Baseline and week 24)
- Change from baseline on the Emotional Difficulties self-efficacy scale at 24 weeks(Baseline and week 24)