BEAT-IT: Behavioural Activation and Severe Learning Disabilities

Behavioural Activation (BeatIt) for Depression in Adults With Severe Intellectual Disabilities. A Feasibility Randomised Controlled Study of BeatIt Versus Treatment as Usual

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 Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Behavioral: Behavioural Activation

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew Jahoda, PhD; Phone Number: 01412110282; Email: Andrew.Jahoda@glasgow.ac.uk
• Study Contact Backup: Name: Craig Melville, PhD; Phone Number: 01412113878; Email: Craig.Melville@glasgow.ac.uk

Study Locations

• United Kingdom
  • Scotland
    • Glasgow, Scotland, United Kingdom, G120XH
      • Recruiting
      • Institute of Health and Wellbeing, University of Glasgow
      • Contact: Andrew Jahoda, PhD
      • Principal Investigator: Andrew Jahoda, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Behavioural Activation; A psychological intervention which aims to increase activity and reduce depressive symptoms.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline on the Mood, Interest and Pleasure Questionnaire (MIPQ) at 24 weeks	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)	Baseline and week 24
Change from baseline on Intellectual Disabilities Depression Scale (IDDS) at 24 weeks	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.	Baseline and week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline on the Anxiety, Depression and Mood Scale at 24 weeks	This scale has been shown to be a reliable and valid measure of anxiety in adults with severe/profound intellectual disabilities. The 7 item 'generalised anxiety' sub-scale was used. Items are rated on a four-point Likert scale for frequency from 0 (never) to 3 (always) and for severity 0 (not a problem) to 3 (severe problem). Items are based on informants' observations in the last 2 weeks. Scores are summed. The possible score range for frequency of anxiety symptoms is 0-21, total score range for severity of anxiety symptoms is 0 - 21 and total score is 0 - 42. Higher scores indicate a higher frequency of anxiety symptoms and higher severity of anxiety symptoms.	Baseline and week 24
Change from baseline on the Modified Index of Community Involvement (ICI) at 24 weeks	This scale provides a measure of participation in social and community-based activities during the previous 4 weeks. This is a 16-item scale, measuring participation in social activities (5 items), community activities (10 items) and going on holiday (1 item). The informant is asked to rate whether the participant has participated in any of these events in the last month (12 months for the item 'been on holiday'), and if so, how many times (once through to five times or more). All items are rated on a 6-point Likert scale (0 = not participated, 5 = participated 5x or more). All scores are summed. The possible score range for the social activities sub-scale is 0-25, the possible score range for the community activities subscale is 0-50 and the total scale score range is 0-80. Higher scores indicate a higher frequency of engagement in social and community activities.	Baseline and week 24
Change from baseline on the Modified Index of Domestic Participation at 24 weeks	This scale measures participation in 13 household tasks during the previous 4 weeks. All items are rated on a three-point Likert scale (0 - no participation, 1 - participation with help, 2 - independent participation). Scores are summed, with a possible score range of 0 - 26. Higher scores indicate higher levels of independent participation in domestic tasks.	Baseline and week 24
Change from baseline on the Emotional Difficulties self-efficacy scale at 24 weeks	This is a 10-item scale which measures the carer's confidence in supporting the person when they are feeling down. All item are scored on a 9-point Likert scale, where 0 indicates 'not at all confident' and 8 indicates 'extremely confident'. All scores are summed with a possible score range of 0 - 80. Higher scores indicate a higher level of self-confidence in supporting someone when they are feeling down.	Baseline and week 24

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Glasgow; Lancaster University
• Investigators: Principal Investigator: Andrew Jahoda, PhD, Professor of Learning Disabilities

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Intellectual Disability
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Depression; Intellectual Disability
• Other Study ID Numbers: GN18MH490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No