BEAT-IT: Behavioural Activation and Severe Learning Disabilities

NCT ID: NCT04744259

Last Updated: 2021-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-18

Study Completion Date

2022-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Behavioural Activation

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Behavioural Activation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Glasgow

OTHER

Sponsor Role collaborator

Lancaster University

OTHER

Sponsor Role collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Jahoda, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Learning Disabilities

Locations

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Institute of Health and Wellbeing, University of Glasgow

Glasgow, Scotland, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Andrew Jahoda, PhD

Role: CONTACT

01412110282

Craig Melville, PhD

Role: CONTACT

01412113878

Facility Contacts

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Andrew Jahoda, PhD

Role: primary

Other Identifiers

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GN18MH490

Identifier Type: -

Identifier Source: org_study_id

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