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.

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.