Dementia Mental and Behavioural Disorders
Conditions
Interventions
Current interventions as of 26/03/2026:
This will be a single-blind randomised controlled trial of group CFT versus treatment as usual (TAU). 304 participants will be randomised to either the interven
Sponsors
North East London NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 26/03/2026: 1. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for dementia of any type 2. Mild to moderate dementia as determined by the following: 2.1. A confirmed dementia diagnosis based on DSM-IV criteria for any type of dementia, AND 2.2. A Clinical Dementia Rating (CDR) score of 0.5, 1, or 2 (Morris, 1997). 3. Experience symptoms of depression and/or anxiety as determined by either: 3.1. A HADS score = 8 on the anxiety and/or depression subscale (Zigmond & Snaith, 1983), OR 3.2. A HADS score of 5–7, accompanied by evidence of low mood as reported by a caregiver or clinician, OR 3.3. Significant psychological distress, as assessed by a clinician or researcher, regardless of the HADS score. 4. Have capacity to consent to take part in research 5. Can communicate in English 6. Have access to WiFi, enabling them to partake in virtual CFT groups, OR the ability to attend a face-to-face group 7. Are not participating in another interventional research programme concurrently 8. Have sufficient hearing to engage in group discussions (with or without hearing aids). 9. Aged 18 years and over 10. People can be included whether or not they have a caregiver. Previous inclusion criteria as of 05/09/2024: 1. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for dementia of any type 2. Mild to moderate dementia as determined by the Clinical Dementia Rating (CDR) 3. Experience symptoms of depression and/or anxiety (8 =) as measured by the Hospital Anxiety and Depression Scale (HADS) OR a minimum score of 5 and experience of depression and/or anxiety as reported by either the caregiver or clinician 4. Have capacity to consent to take part in research 5. Can communicate in English 6. Have access to WiFi, enabling them to partake in virtual CFT groups, OR the ability to attend a face-to-face group 7. Are not participating in another interventional research programme concurrently 8. Aged 18 years and over 9. People can be included whether or not they have a caregiver. Original inclusion criteria: 1. Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for dementia of any type 2. Mild to moderate dementia as determined by the Clinical Dementia Rating (CDR) 3. Experience symptoms of depression and/or anxiety (8 > = ) as measured by the Hospital Anxiety and Depression Scale (HADS); 4. Have capacity to consent to take part in research; 5. Can communicate in English, 6. Have access to WiFi, enabling them to partake in virtual CFT groups, OR the ability to attend a face-to-face group; 7. Are not participating in another interventional research programme concurrently. 8. Aged 18 years and over 9. People can be included whether or not they have a caregiver.
Exclusion criteria
Exclusion criteria: 1. Communication is significantly impaired by cognitive decline 2. Unable to speak English 3. The participant is currently participating in another interventional research programme. 4. The participant has severe cognitive impairment as measured by the Clinical Dementia Rating scale.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcomes as of 26/03/2026: Symptoms of depression measured by the Cornell Scale for Depression in Dementia (Cornell) at 16 weeks (post-intervention) Previous primary outcomes: Feasibility outcomes: 1. Feasibility of recruitment and retention, assessed by: 1.1. Successful recruitment of the target sample (50 people) in 14-months 1.2. Retention rate of at least 75% of participants to 16 week follow up. We will also evaluate how feasible it is to recruit anxious people to a group intervention how anxiety impacts upon uptake. 2. Acceptability of the intervention, assessed by: 2.1. Overall attendance and retention rates amongst the CFT participants (over 60%) 2.2. Any negative or adverse events related to the intervention 2.3. Level of engagement in the sessions, measured using participation forms developed alongside the CFT manual, (d) preference of virtual or face-to-face. 3. Fidelity, assessed by: 3.1. Therapist completion of the fidelity checklist following each session and 3.2. Audio recording all sessions and an independent researcher rating fidelity with a random 10% of the recordings. A total, mean fidelity score and percentage will be calculated for each CFT session. These scores will be compared across site and provider. We will also compare self-report with observer ratings, providing some idea about the utility of self-report in a future trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcomes as of 26/03/2026: 1. Symptoms of depression measured by the Cornell Scale for Depression in Dementia (Cornell) at 6 months 2. Symptoms of anxiety measured by the Rating Anxiety in Dementia Scale (RAID) at 16 weeks (post-intervention) and 6 months 3. Quality of life and proxy quality of life measured by the Dementia Quality of Life Scale (DEMQOL) at 16 weeks (post-intervention) and 6 months 4. Health-related quality of life measured by the EQ-5D-5L at 16 weeks (post-intervention) and 6 months 5. Cognitive function measured by the Montreal Cognitive Assessment (MoCA) at 16 weeks (post-intervention) and 6 months 6. Self compassion measured by the Short Self-Compassion Scale (SCS-SF) at 16 weeks (post-intervention) and 6 months 7. Relationship with caregiver measured by the Quality of Caregiver and Patient Relationship scale (QCPRS) at 16 weeks (post-intervention) and 6 months 8. Resource use measured by the Client Service Receipt Inventory (CSRI) at 16 weeks (post-intervention) and 6 months 9. Relationship with caregiver, from both the perspective of the person with dementia and the caregiver, measured by the 10. Quality of Caregiver and Patient Relationship scale (QPCR) at 16 weeks (post-intervention) and 6 months 11. Caregiver burden measured by the Zarit Burden Interview (ZBI) at 16 weeks (post-intervention) and 6 months Previous secondary outcomes: 1. Symptoms of depression are measured by the Cornell Scale for Depression in Dementia, at baseline (pre-intervention), 16 weeks (post-intervention) and 6 months. 2. Symptoms of anxiety is measured using the Rating Anxiety in Dementia Scale (RAID) scale, at baseline (pre-intervention), 16 weeks (post-intervention) and 6 months 3. Quality of life is measured using the EQ-5D-5L scale, at baseline (pre-intervention), 16 weeks (post-intervention) and 6 months 4. Quality of life is measured using the DEMQOL scale, DEMQOL-proxy is collected from the carer (if available), at baseline (pre-intervent | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed