A therapist is teaching people with dementia and depression a new way to solve everyday problems—like remembering appointments or managing frustration—rather than just prescribing pills. Depression affects roughly one in five people with dementia, yet standard talking therapies often fail because they demand too much memory or abstract thinking. This trial adapts an existing therapy called Problem Adaptation Therapy (PATH) specifically for people with mild to moderate dementia, training NHS therapists to deliver it in community settings. The core problem is that current treatments—mainly antidepressants and generic support—do not reliably lift mood in this group, leaving many patients and their carers struggling with low quality of life. If the therapy works, it could give the NHS a practical, non-drug option for treating depression in dementia that is tailored to patients’ cognitive abilities. That would mean fewer people cycling through ineffective medications, less carer burden, and a measurable improvement in daily functioning—from managing household tasks to maintaining social connections. The trial also tracks costs, so health commissioners would know whether the therapy saves money by reducing hospital visits or care-home admissions.
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PHASE 1 (months 1-12): Adapt intervention based on PATH for delivery in the NHS through interviews with 15-20 patient-carer dyads and 4 professionals' workshops. Assess acceptability to patients, carers and therapists, and likely uptake and adherence. Proceed to Phase 2 if credibility and expectancy scores are >70%, >70% participants complete 2 sessions, ratings are satisfactory on Client Satisfaction Questionnaire (CSQ [35]) and >5 modifiable problems are identified per person. PHASE 2 (months 13-54): Assess clinical and cost effectiveness of adapted PATH for depression in dementia in a 6-centre single-blind parallel 2-arm RCT with an internal pilot in the first 12 months to assess feasibility of recruitment and acceptability of randomisation. Continue to full RCT if recruit 125 patients (75% of target). SETTING: Community. PARTICIPANTS: 333 people with mild to moderate dementia recruited from Memory Services and CMHTs. INCLUSIONS: Mild to moderate Alzheimer's disease (AD) or mixed AD/vascular dementia (SMMSE 10+) with clinically significant depression (score of 8+ on Cornell Scale for Depression in Dementia [CSDD (4)]); sufficiently fluent in English to engage with PATH; identified carer who spends 1hr+ per day on at least 3 days/week with the participant. Psychotropics allowed if dose has not changed in previous 4 weeks and no plan to change during next 12 weeks of PATH. INTERVENTION: PATH adapted for people with dementia plus TAU. Psychiatric nurses, occupational therapists, assistant psychologists and psychological wellbeing practitioners from Memory Services, CMHTs and IAPTs will be trained to deliver 10 manualised sessions over 12 weeks under regular supervision from clinical psychologists. Random sessions will be assessed for treatment fidelity. COMPARATOR: TAU within which participants will have access to psychotropics, supportive and other therapies at discretion of responsible clinicians. RANDOMISATION: 1:1 stratified randomisation via CTU online system. PRIMARY OUTCOME: Change in CSDD score from baseline to 6 months. SECONDARY OUTCOMES: Patients: CSDD at 3 and 12 months; change in disease-specific health-related quality of life with DEMQOL and DEMQOL-proxy (27), generic quality of life with EQ-5D (28); function with Bristol Activities of Daily Living Scale (29); cognitive function with SMMSE (20); anxiety with Rating Anxiety in Dementia scale (30); cost-effectiveness with Client Service Receipt Inventory (31); satisfaction with CSQ. Carers: Burden with Zarit Burden Inventory (32); mental health with General Health Questionnaire-12 (33). TIMING OF OMs: Assessment at 0, 3, 6 (primary endpoint) and 12 months post-randomisation by blind outcome assessors. SAMPLE SIZE: 333 participants will allow detection of a minimum clinically important difference of 2.0 points on the CSDD (an effect size of 0.4 SD) with a 2-sided alpha of 5% and 90% power, assuming 20% loss to follow-up at 6 months. TIMETABLE: 1-9 months: Ethical/research approval, adapt intervention, train clinicians. 7-12 months: Assess acceptability, RCT set-up. 13-36 months: RCT recruitment with internal pilot in months 13-24. 37-48 months: Follow-up. 49-54 months: Database lock, analyses, dissemination. OUR TEAM: Has experience of successfully delivering multi-site trials, with expertise in dementia (RHo/GL/RD/PB/SB/CF/PW/AT/VO/RG), developing psychotherapy manuals (GL/VO/KL/PW/RG), qualitative research (VL/VO/GL), statistics (NF) and health economics (RHu).
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