Clinical trial Recruiting at 1 site Interventional Ages 18 to 100

COPE: a blended (face-to-face and online) program to lower expressed emotion in family caregivers of people with dementia

Official title: Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia: a Pilot Randomized Controlled Trial

Run by The University of Hong Kong · NCT07305415 · Data updated 2026-11-12

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.

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Quick facts

Study typeInterventional
Ages18 Years to 100 Years
SexAll
Enrollment56 (estimated)
SponsorThe University of Hong Kong
Academic / other
Locations1 site (Hong Kong)
StatusRecruiting
StartedDecember 20, 2025
Main results expectedNovember 30, 2026
Study endsMarch 30, 2027
Registry record updatedNovember 2, 2026
Trial IDNCT07305415 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • University of Hong Kong
    Hong Kong, Hong Kong
    Recruiting

Study contacts

  • Principal investigator: Doris Sau Fung YU, PhD — The University of Hong Kong
  • Study coordinator: Doris Sau Fung YU, PhD
  • Email: dyu1@hku.hk
  • Phone: +852 39176319

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.