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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The dual-modal (face-to-face and online approaches), client-customized Caregivers Of dementia Processing Emotions (COPE) programme aims to 1. reduce caregivers' Expressed Emotion (EE), 2. reduce caregivers' depressive symptoms, 3. reduce the behaviourally interactive social dynamic of maladaptation (i.e., dysfunctional dyadic relationship and quality of care), and 4. improve caregivers' perceived stress from PwD's Behavioral and Psychological Symptoms of Dementia (BPSD). Researchers will compare COPE to a control group (standard therapy) to examine how effective the COPE programme is. Participants will take part in: Pretest prior to COPE implementation Post-test after COPE completion Follow up test in 3 months after COPE completion

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• (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

Locations
Other Locations
Hong Kong Special Administrative Region
University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
YU Sau Fung, RN, PhD, FHKAN, FAAN, FGSA
dyu1@hku.hk
852 + 39176319
Time Frame
Start Date: 2025-12-20
Estimated Completion Date: 2027-03-30
Participants
Target number of participants: 56
Treatments
Experimental: COPE Intervention Group
COPE is a 6-week group-based programme comprising one face-to-face workshop (4 caregivers per group) and five online sessions (4 caregivers per group) delivered via Zoom. The COPE programme integrates the strategies from cognitive behavioral therapy (CBT), emotional-focused mindfulness therapy and social skill training to improve the expressed emotion (EE) of the caregivers, with the focus to ameliorate negative causal attrition of BPSD, increase emotional regulation and enhance social interaction skills with PwD. The group size of 4 is used to optimize the social interactions between the peer caregivers. The first session will adopt a face-to-face mode to better develop their rapport with each other, and to facilitate their self-reflection and disclosure on their social interaction with the care recipients in day-to-day caregiving.
Active_comparator: Control group
Structured education will function as the control intervention to mitigate potential confounding effects attributable to additional attention. The control condition will comprise one initial face-to-face session followed by five consecutive weekly online educational sessions focusing on dementia caregiving. These sessions will be administered by a research assistant (RA2) following a standardized PowerPoint presentation developed in accordance with established clinical practice guidelines. The implementation of an active control condition, rather than a passive or waitlist control, provides more robust evidence regarding the specific efficacy of the experimental intervention. Furthermore, this approach enhances both participant recruitment and retention rates by ensuring that all participants receive a credible and potentially beneficial intervention.
Related Therapeutic Areas
Sponsors
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov