A talking therapy that helps people with dementia reduce self-criticism and shame is being tested in a large NHS trial to see if it can treat the depression and anxiety that often accompany the condition. Depression and anxiety affect many people with dementia, accelerating cognitive decline and increasing the need for institutional care. Yet no drug or psychological therapy has proven effective for this group. This trial builds on a smaller feasibility study of 73 people, which showed that Compassion-Focused Therapy (CFT)—a therapy that helps people manage difficult emotions and adjust to their diagnosis—is practical to deliver in the NHS. If successful, CFT could fill a critical treatment gap. The trial will recruit 304 people with mild-to-moderate dementia and depression or anxiety, comparing group CFT plus usual care against usual care alone. Researchers will measure mood, quality of life, cognition, and caregiver burden, and assess whether the therapy saves the NHS money by reducing medication use and hospital visits. The therapy could help people with dementia maintain independence longer and reduce the strain on caregivers, without requiring expensive new infrastructure or technology.
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Key research question: How effective and cost-effective is group CFT for people with dementia and depression and/or anxiety within the NHS? Background: Depression and anxiety are common in dementia and have devastating impacts including accelerated cognitive decline, increased need for institutional care and death. There are currently no pharmacological treatments or psychological therapies with established efficacy, resulting in a critical gap in the treatment of people with dementia. Compassion Focused Therapy (CFT) is a talking therapy that focuses on reducing self-criticism and shame, common in early stages of dementia. It acknowledges the emotional impact of difficult experiences and facilitates adjustment and acceptance. Our current RfPB funded feasibility trial (n=73) has demonstrated that CFT for people with dementia is feasible in terms of recruitment, retention, attrition and fidelity; with positive qualitative findings emerging including observed improvements in mood from both participants and their caregivers. This proposed study aims to extend the current work into a fully powered, two arm RCT which will: Evaluate the efficacy of CFT in improving depression (primary outcome), anxiety, quality of life, cognition, self-compassion, and the caregiver-patient relationship; in people with dementia (and anxiety and/or depression), compared to treatment as usual (TAU). Evaluate caregiver burden, caregiver perception of the caregiver-patient relationship and proxy-reported quality of life (if caregiver is available), compared to TAU. Assess the cost-effectiveness of group CFT compared to TAU. Explore differences in outcomes between face-to-face and online groups; preferences for delivery format and potential predictors of success in the intervention as part of a secondary, exploratory analysis. Methods: This study will follow on immediately from the current feasibility trial, ending in September 2025. 231 people with mild-to-moderate dementia and anxiety and/or depression will be recruited to a two-armed RCT (CFT plus TAU vs TAU). Our feasibility trial will be treated as an internal pilot and data added, resulting in a total sample of 304. Primary caregivers, if available, will be invited to a brief workshop focusing on principles of CFT and supporting the person at home. Blind assessments will be conducted at baseline, 16 weeks and 6 months follow up, to collect data on the outcomes listed above. We will also collect data on health and social care use at each timepoint, to calculate the cost-effectiveness of CFT. Timeline: Due to all trial processes established and active from the current feasibility trial, we will commence a second round of recruitment from the seven existing NHS sites within two months of starting the trial, and establish a further five sites within the first eight months. The trial will last for three years. 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 caregiver 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.
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