Group cognitive stimulation therapy versus usual care for people with intellectual disabilities and dementia (CST-IDD) in the UK: protocol for a mixed-methods feasibility randomised controlled trial

Afia Ali; Elisa Aguirre; Joanna Carter; Sarah Hoare; Kate Brackley; Nia Goulden; Zoe Hoare; Caroline S Clarke; Georgina Charlesworth; Danny Acton; Aimee Spector

doi:10.1136/bmjopen-2023-072391

Group cognitive stimulation therapy versus usual care for people with intellectual disabilities and dementia (CST-IDD) in the UK: protocol for a mixed-methods feasibility randomised controlled trial

BMJ Open. 2023 Apr 28;13(4):e072391. doi: 10.1136/bmjopen-2023-072391.

Authors

Afia Ali¹, Elisa Aguirre², Joanna Carter³, Sarah Hoare⁴, Kate Brackley⁵, Nia Goulden⁶, Zoe Hoare⁶, Caroline S Clarke⁷, Georgina Charlesworth⁸, Danny Acton⁹, Aimee Spector¹⁰

Affiliations

¹ Unit of Social and Community Psychiatry, East London NHS Foundation Trust, London, UK afia.ali4@nhs.net.
² Psychology Department, Universidad Europea de Madrid, Madrid, Spain.
³ Research Department of Clinical, Educational & Health Psychology, University College London, London, UK.
⁴ Research and Development, North East London NHS Foundation Trust, Rainham, UK.
⁵ Birmingham Research Park, British Institute of Learning Disabilities, Edgbaston, UK.
⁶ North Wales Organisation for Randomised Trials in Health (NWORTH), Bangor University, Bangor, UK.
⁷ Research Department of Primary Care and Population Health, University College London, UCL Medical School, London, UK.
⁸ Unit of Behavioural Medicine, University College London, London, UK.
⁹ Wirral Community Learning Disabilty Team, Cheshire and Wirral Partnership NHS Foundation Trust, Chester, UK.
¹⁰ Department of Clinical, Educational and Health Psychology, University College London, London, UK.

Abstract

Introduction: The prevalence of dementia is almost five times higher in people with intellectual disabilities compared with the general population. However, evidence-based treatments for this population are lacking, as most randomised controlled trials for dementia interventions have not included people with intellectual disabilities. Cognitive stimulation therapy (CST) has a robust evidence base in the general dementia population, consistently showing benefits to cognition, quality of life and being cost-effective. We are conducting a mixed-methods feasibility trial of group CST for people with intellectual disabilities and dementia, to determine if a future definitive randomised controlled trial is feasible.

Methods and analysis: Fifty individuals with intellectual disabilities and dementia will be randomised to either the intervention arm (14 sessions of group CST plus treatment as usual) or the control arm (treatment as usual). Randomisation will occur after informed consent has been obtained and baseline assessments completed. Each arm will have 25 participants, with the intervention arm divided into five or more CST groups with three to five participants in each. The outcomes will be feasibility of recruitment, acceptability and adherence of the intervention, suitability of study outcome measures and feasibility of collecting resource use data. Quantitative and qualitative approaches, including semistructured interviews with group participants, carers and group facilitators, will be employed to assess these outcomes.

Ethics and dissemination: This study has been approved by Essex REC (Ref: 21/EE/027) and the HRA ethical approval process through the Integrated Research Application System (IRAS ID: 306 756). We plan to publish the results in peer-reviewed journals and conferences as well as provide feedback to funders, sponsors and study participants.

Trial registration number: ISRCTN88614460.

Keywords: Dementia; Old age psychiatry.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Cognition
Cost-Benefit Analysis
Dementia* / psychology
Dementia* / therapy
Feasibility Studies
Humans
Intellectual Disability* / therapy
Quality of Life
Randomized Controlled Trials as Topic
United Kingdom

Associated data

ISRCTN/ISRCTN88614460