Behavioural Activation and Severe Learning Disabilities

NCT06851741 | Not Yet Recruiting

• 1 other identifier: GN22MH146
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Research shows that people with severe learning disabilities get depressed at least as often as the wider population. Psychological therapies are recommended to treat depression, and some of these have been adapted for those people with learning disabilities who can talk about their problems. No research has properly tested a psychological therapy for people with severe learning disabilities and any mental health problem. The investigators recently completed a study that tested a psychological therapy (behavioural activation) for people with mild learning disabilities and depression. Behavioural activation improves people's mood by helping them to re-engage in activity that has meaning and purpose for them, rather than relying on talking or thinking skills. Because of this behavioural activation might be promising for people with severe learning disabilities and depression. Along with PAMIS, an organisation for families of people with more profound disabilities, the investigators have adapted the therapy for this group. The investigators now want to find out if it would be possible to carry out a research project about whether behavioural activation works for depressed adults with severe learning disabilities. This is called a feasibility study. The investigators would see if it is possible to recruit 50 adults with severe learning disabilities, and if they are willing to be randomly placed in a group who get behavioural activation or a group who get usual help from services. Other information about running a study would be collected, including about keeping in contact with participants and what measures are needed to find out if change is happening.

Conditions

Intellectual Disabilities; Depression

Keywords

Intellectual disability; Depression

Outcome Measures

Primary Outcomes (1)

• Intellectual Disabilities Depression Scale (IDDS)

  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. Minimum possible score is 0 and maximum possible score is 228. Higher scores indicate a higher frequency of depressive symptoms.

  Baseline, 4, 6, 8, 12 months post-baseline

Secondary Outcomes (10)

• Anxiety Depression and Mood Scale (ADAMS)

  Baseline & 12 months post-baseline

• Index of Community Involvement

  Baseline & 12 months post-baseline

• Index of Participation in Domestic Life

  Baseline & 12 months post-baseline

• EQ-5D-5L

  Baseline & 12 months post-baseline

• The Behaviour Problems Inventory - Short form (BPI-S)

  Baseline & 12 months post-baseline

Study Arms (2)

BeatIt2 for depression alongside Treatment as usual (TAU)

EXPERIMENTAL

BeatIt2 treatment manual and materials are developed and modelled for people with severe/profound learning disabilities. They are designed to be delivered to the person alongside a family or paid carer providing them with regular support, on an outreach basis. It is a structured, time limited, manualised psychological therapy, developed to treat those with learning disabilities and depressive symptoms. There is an initial training session for carers regarding their role in the treatment, then 12 sessions with the person with a learning disability and their carer, held weekly or fortnightly, spanning approximately 6 months. Activities are carried out with the individuals with learning disabilities at each session and elements of the intervention are delivered via carers. The three main phases are: i) assessment and socialisation into the intervention and establishing a relationship with the person with the disability, ii) working towards change, and iii) finishing therapy.

Behavioral: Behavioural Activation for depression (BeatIt2)

Treatment as usual

NO INTERVENTION

This will include the existing treatments available in NHS and social care for adults with learning disability with depression, including anti-depressants, mood stabilizers, and any available nursing and psychological supports/interventions. Additionally, for all those in the study, the investigators will provide their General Practitioner and specialist services with a summary of the NICE guidelines on treatment of depression for adults with learning disabilities.

Interventions

Behavioural Activation for depression (BeatIt2) BEHAVIORAL

It is a structured, time limited, manualised psychological therapy, developed to treat those with learning disabilities and depressive symptoms. There is an initial training session for carers regarding their role in the treatment, then 12 sessions with the person with a learning disability and their carer, held weekly or fortnightly, spanning approximately 6 months. Activities are carried out with the individuals with learning disabilities at each session and elements of the intervention are delivered via carers. The three main phases are: i) assessment and socialisation into the intervention and establishing a relationship with the person with the disability, ii) working towards change, and iii) finishing therapy. The first phase includes assessment of the person's pattern of daily activity, barriers and facilitators to engaging in activity, and examining the link between activity and mood. Specific attention is given to the role of communication and how scaffolding can be provid

BeatIt2 for depression alongside Treatment as usual (TAU)

Eligibility Criteria

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

You may qualify if:

• Administratively defined severe/profound learning disabilities, confirmed by carer report using the Vineland Adaptive Behaviour Scales 3rd edition. A severe/profound learning disability will be confirmed by an ABC composite score of 50 or below (Sparrow et al., 2016). Individuals with severe/profound learning disabilities can be characterised by high support needs, limited or no expressive or receptive verbal communication, and significant impairments across adaptive functioning skills.
• years old and over
• Clinically significant unipolar depression, meeting the Diagnostic Criteria for Psychiatric Disorders for use with Adults with Learning Disabilities
• 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:

• Mild/moderate learning disabilities
• A presentation judged by the research team as likely to interfere with the successful engagement with the intervention (e.g. severe agitation, late-stage dementia, uncontrolled epilepsy).

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

MeSH Terms

Conditions

Intellectual Disability; Depression

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Andrew Professor Jahoda, BSc Hons, MPhil, PhD

CONTACT

0141 330 4988; Andrew.Jahoda@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research assistants carrying out the assessments will be masked to intervention allocated and/or received. Masking will be maintained using a wide range of procedures, including separate offices for the therapists and research assistants carrying out assessments (where they are located in the same building), protocols for answering telephones, message taking and secretarial support, separate diaries, pigeonholes and data file security, and using passwords and encryption of randomisation information.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 28, 2025
• Study Start: March 4, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 28, 2025

Record last verified: 2024-11