Clinical trial NCT04744259: BEAT-IT: Behavioural Activation and Severe Learning Disabilities
Official title: Behavioural Activation (BeatIt) for Depression in Adults With Severe Intellectual Disabilities. A Feasibility Randomised Controlled Study of BeatIt Versus Treatment as Usual
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Intellectual Disability
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
name: Lancaster University
First posted: 2021-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

* Suicidal
* 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.

Primary outcomes:
measure: Change from baseline on the Mood, Interest and Pleasure Questionnaire (MIPQ) at 24 weeks
timeFrame: Baseline and week 24
measure: Change from baseline on Intellectual Disabilities Depression Scale (IDDS) at 24 weeks
timeFrame: Baseline and week 24
Secondary outcomes:
measure: Change from baseline on the Anxiety, Depression and Mood Scale at 24 weeks
timeFrame: Baseline and week 24
measure: Change from baseline on the Modified Index of Community Involvement (ICI) at 24 weeks
timeFrame: Baseline and week 24
measure: Change from baseline on the Modified Index of Domestic Participation at 24 weeks
timeFrame: Baseline and week 24
measure: Change from baseline on the Emotional Difficulties self-efficacy scale at 24 weeks
timeFrame: Baseline and week 24
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Institute of Health and Wellbeing, University of Glasgow
state: Scotland
Study officials:
affiliation: Professor of Learning Disabilities
name: Andrew Jahoda, PhD
role: PRINCIPAL_INVESTIGATOR
References: