COPE: a blended (face-to-face and online) program to lower expressed emotion in family caregivers of people with dementia
Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia: a Pilot Randomized Controlled Trial
This six-week COPE program will test whether a blended, personalized intervention helps family caregivers of people with dementia reduce expressed emotion, depressive symptoms, and perceived stress from BPSD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07305415 on ClinicalTrials.gov |
What this trial studies
This randomized, parallel two-arm trial assigns caregivers to either the COPE program or standard therapy, with baseline, post-intervention (after six weeks), and three-month follow-up assessments collected face-to-face or online. COPE is a dual-modal, client-customized intervention combining in-person and online components focused on processing emotions and modifying expressed emotion. Participants and outcome assessors are masked to allocation, and the trial aims to enroll at least 56 caregivers to detect small-to-medium effects with 80% power. Eligibility requires a high Family Attitude Scale score (≥35), at least four hours of caregiving per day, and no acute psychiatric illness.
Who should consider this trial
Good fit: Family caregivers who provide at least four hours of care per day, score 35 or higher on the Family Attitude Scale (Chinese version), consent to participate, and do not have an acute psychiatric illness.
Not a fit: Caregivers with FAS-C scores below 35, those who provide no more than four hours of care per day, or those with acute psychiatric illness are unlikely to benefit or be eligible for this program.
Why it matters
Potential benefit: If successful, COPE could lower caregivers' expressed emotion, depressive symptoms, and perceived stress from BPSD, improving caregiver–patient relationships and quality of care.
How similar studies have performed: Previous emotion-focused and psychoeducational interventions for dementia caregivers have shown reductions in caregiver stress and mood symptoms in some trials, though effectiveness varies by content, intensity, and delivery mode.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) With a high level of EE as indicated by a cut-off score of 35 or above on the Family Attitude Scale (Chinese version; FAS-C) * (2) Provides care at least 4 hours per day * (3) Consent to participate * (4) No acute psychiatric illness Exclusion Criteria: * (1) With a score below 35 on the Family Attitude Scale (Chinese version; FAS-C) * (2) Provides care no more than 4 hours per day * (3) Does not consent to participate * (4) With acute psychiatric illness.
Where this trial is running
Hong Kong
- University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: YU Sau Fung, RN, PhD, FHKAN, FAAN, FGSA
- Email: dyu1@hku.hk
- Phone: 852 + 39176319
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.