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Search / Trial NCT06851741

Behavioural Activation and Severe Learning Disabilities

Launched by NHS GREATER GLASGOW AND CLYDE · Feb 26, 2025

Trial Information

Current as of July 01, 2025

Not yet recruiting

Keywords

Intellectual Disability Depression

ClinConnect Summary

This clinical trial is studying a type of therapy called behavioral activation to see if it can help adults with severe learning disabilities who are experiencing depression. Behavioral activation focuses on encouraging individuals to engage in meaningful activities that can improve their mood, instead of relying solely on talking about their feelings. The researchers aim to find out if they can successfully recruit 50 adults with severe learning disabilities to participate in this study, where some will receive the new therapy while others will continue with their usual support services.

To be eligible for the study, participants need to be 18 years or older, have a severe learning disability as confirmed by their caregivers, and be experiencing significant depression. It's important that they have a family member or caregiver who can support them during the study. The trial is not yet recruiting participants, but it aims to gather information on how to effectively carry out the research, including how to maintain contact with participants and measure changes in their mood and well-being. This study could help develop better support options for individuals with severe learning disabilities and depression.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • 18 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.
  • Exclusion Criteria:
  • 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).

About Nhs Greater Glasgow And Clyde

NHS Greater Glasgow and Clyde (NHS GG&C) is one of the largest health organizations in the UK, dedicated to delivering high-quality healthcare services to a diverse population. As a clinical trial sponsor, NHS GG&C plays a pivotal role in advancing medical research and improving patient outcomes through innovative clinical studies. The organization is committed to upholding rigorous ethical standards and regulatory compliance, ensuring that all trials are conducted with the utmost care for participant safety and scientific integrity. With a focus on collaboration, NHS GG&C partners with academic institutions, healthcare professionals, and industry stakeholders to foster an environment conducive to groundbreaking research and the development of new therapies.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported