Being kind to ourselves: group compassion-focused therapy (CFT) versus treatment as usual (TAU) to improve depression and anxiety in dementia a protocol for a mixed-methods feasibility randomised controlled trial within the NHS
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Authors
Spector, Aimee
Melville, Mel
Craig, Catriona
Henderson, Catherine
Hiskey, Syd
Knapp, Martín
Kusel, Yvette
Oliver, Keith D
Robinson, Louise
Royan, Lindsay
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Issue Date
03/12/2024
Type
Journal article
Language
Keywords
Specialist and Integrated
Alternative Title
Abstract
Description
Introduction
Depression and anxiety are common in dementia, with a devastating impact. However, there remains a lack of evidence-based psychological therapies for this clinical group. Compassion-focused therapy (CFT), a talking therapy which addresses feelings of shame and stigma, has shown benefits in other clinical populations. This study is a mixed-methods feasibility randomised controlled trial (RCT) of group CFT for people with dementia and symptoms of anxiety and/or depression, to determine if a future definitive RCT is feasible.
Methods and analysis
50 people with mild-to-moderate dementia and symptoms of anxiety and/or depression will be randomised to either the intervention arm (12 sessions of group CFT plus treatment as usual (TAU)) or the control arm (TAU). Primary outcome measures include the feasibility of conducting an RCT in terms of recruitment, acceptability, suitability of secondary outcome measures and fidelity. Blind assessments will be conducted at baseline, approximately 16 weeks and 6 months follow-up, to collect data on depression, anxiety, quality of life, quality of the carer-patient relationship, cognition, self-compassion and carer burden. Qualitative interviews will be used to gather participant, carer/supporter and clinician perspectives on the value, acceptability and feasibility of the intervention.
Ethics and dissemination
This study has been approved by the London Riverside REC (Ref: 23/LO/0535) and the Health Research Authority (HRA) ethical approval process through the Integrated Research Application System (IRAS ID: 327086). We plan to publish the results in open-access peer-reviewed journals, present data at conferences and provide feedback to the study participants, sponsors and funders. Trial registration number ISRCTN20868432 .
Citation
BMJ Open 2024;14:e093249. doi: 10.1136/bmjopen-2024-093249
Publisher
License
Journal
BMJ Open
Volume
14
Issue
12