BEAT-IT: Behavioural Activation and Severe Learning Disabilities

NCT04744259 | Unknown

• 1 other identifier: GN18MH490
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Intellectual Disability

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

Behavioural activation

EXPERIMENTAL

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

Treatment as usual

NO INTERVENTION

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.

Interventions

Behavioural Activation BEHAVIORAL

A psychological intervention which aims to increase activity and reduce depressive symptoms.

Behavioural activation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe/profound intellectual disabilities
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator
• Lancaster University: collaborator

Study Sites (1)

Institute of Health and Wellbeing, University of Glasgow

Glasgow, Scotland, G120XH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Depression; Intellectual Disability

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Andrew Jahoda, PhD

  Professor of Learning Disabilities

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Jahoda, PhD

CONTACT

01412110282; Andrew.Jahoda@glasgow.ac.uk

Craig Melville, PhD

CONTACT

01412113878; Craig.Melville@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: February 8, 2021
• Study Start: February 18, 2019
• Primary Completion: December 1, 2021
• Study Completion: April 1, 2022
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)