Being kind to ourselves: A feasibility randomised controlled trial of Compassion Focused therapy (CFT) to improve depression and anxiety in Dementia
Award Number
NIHR203524Programme
Research for Patient BenefitStatus / Stage
CompletedDates
1 March 2023 -30 August 2025
Duration (calculated)
02 years 05 monthsFunder(s)
NIHRFunding Amount
£249,865.00Funder/Grant study page
NIHRContracted Centre
North East London NHS Foundation TrustPrincipal Investigator
Professor Aimee SpectorPI Contact
a.spector@ucl.ac.ukPI ORCID
0000-0003-4448-8143WHO Catergories
Tools and methodologies for interventionsDisease Type
Dementia (Unspecified)CPEC Review Info
| Reference ID | 211 |
|---|---|
| Researcher | Reside Team |
| Published | 12/06/2023 |
Data
| Award Number | NIHR203524 |
|---|---|
| Status / Stage | Completed |
| Start Date | 20230301 |
| End Date | 20250830 |
| Duration (calculated) | 02 years 05 months |
| Funder/Grant study page | NIHR |
| Contracted Centre | North East London NHS Foundation Trust |
| Funding Amount | £249,865.00 |
Abstract
(1) How feasible is group CFT within the NHS in terms of recruitment, acceptablilty and fidelity? (2) Is there an indication that CFT improves depression and anxiety in people with dementia, comparted to treatment as usual (TAU), (3) Is a full randomised controlled trial (RCT) warranted? If so, what sample size is required. Background: Depression and anxiety are common in dementia and have devastasting impacts including accelerated cognitive decline, increased need for insitutional care and death. There are currently no pharmacological treatments or psychological therapies with established efficacy, resulting in a critical gap in the treatment and care of people with dementia. Compassion Focused Therapy (CFT) is a talking therapy that focuses on reducing self-criticism and shame (common in the early stages of dementia), acknowledging the emotional impact of difficult experiences and facilitating adjustment and acceptance. Our published CFT case series (n=7) found clinically significant changes in depression (n=4) and anxiety (n=3), highlighting feasibility and potential. This study aims to evaluate the feasibility of CFT in a group format for people with dementia and depression and/or anxiety. Aims and objectives: 1. To establish feasibility of recruitment: 2. To establish acceptability of CFT as a virtual or face-to-face intervention for people with dementia; 3. To assess intervention fidelity; 4. To establish preliminary intervention efficacy; 5. To establish suitability of study outcome measures including cost-effectiveness measures; 6. To gather data to inform the decision of the primary outcome for a full RCT, establish whether a full RCT is warranted and obtain estimates of parameters to inform the calculation of the required sample size for a full RCT (if appropriate); 7. To use qualitative and quantitative findings to modify the treatment manual (if required). Methods: A CFT intervention, developed by the team, will be adapted for delivery in a group format (to include a fidelity checklist) at a consensus meeting involving stakeholders (PPI and CFT clinicians). 50 people with mild to moderate dementia and anxiety and/or depression will be recruited to a two-armed RCT (CFT plus TAU vs TAU). Primary carers, if available, will be invited to a brief workshop focussing on principles of CFT and supporting the person at home. Blind assessments will be conducted at baseline, 12 weeks and 6 months follow up, to collect data on depression, anxiety, quality of life, cognition, self-compassion and carer stress. Qualitative interviews will be used to gather participant, carer and clinician perspectives on the value, acceptability and feasibility of the intervention Timeline:. We will prepare an application to the NIHR HTA Programme for a definitive RCT, submitted within 6 months of completion. Anticipated Impact and Dissemination: CFT could fill a critical treatment gap for depression and anxiety in dementia. It could offer hope and reduce stigma, excess disability and social exclusion, e.g. by increasing independence and reducing carer burden. Costs to the NHS might be reduced through decreased service and medication use. Without this research, people with dementia complicated by depression and anxiety could be denied access to potentially effective psychological treatments.
Aims
1. To establish feasibility of recruitment: 2. To establish acceptability of CFT as a virtual or face-to-face intervention for people with dementia; 3. To assess intervention fidelity; 4. To establish preliminary intervention efficacy; 5. To establish suitability of study outcome measures including cost-effectiveness measures; 6. To gather data to inform the decision of the primary outcome for a full RCT, establish whether a full RCT is warranted and obtain estimates of parameters to inform the calculation of the required sample size for a full RCT (if appropriate); 7. To use qualitative and quantitative findings to modify the treatment manual (if required).