Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia: a Pilot Randomized Controlled Trial
NCT ID: NCT07305415
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
56 participants
INTERVENTIONAL
2025-12-20
2027-03-30
Brief Summary
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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
Detailed Description
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Interventional Study Model:
Parallel: Participants are assigned to one of two groups in parallel for the duration of the study.
Model Description:
Participants are assigned to either COPE group or control group on a random basis. Baseline data are collected either face-to-face or online before the implementation. After six weeks of implementation, post-test data will be collected either face-to-face or online. Three months after post-test, follow-up data will be collected either face-to-face or online.
Number of Arms:
Two total arms, one for the COPE intervention group and one for the standard therapy control group.
Masking:
Participants Outcomes Assessors
Allocation:
Randomized: Participants are assigned to intervention groups by chance
Enrollment:
At least 56 subjects are needed for the two arms to allow the most accurate variance estimation for intervention of small to medium standardised effect size (0.2-0.6) at 80% power and 5% level of significance, with a 10% attrition rate. The social workers in the Psychogeriatric Day Hospital (Queen Mary Hospital) will refer the potential family caregivers of PwD to the RA for eligibility screening. Informed consent will be obtained accordingly.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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 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.
Caregivers Of dementia Processing Emotions (COPE)
This is the first study to develop an easily accessible and feasible intervention programme, namely the Caregivers Of dementia Processing Emotions (COPE), to primarily reduce EE in family caregivers of PwD via processing one's attributional biases, dysregulated emotion, dysfunctional social dynamics using an integrative therapy. By displacing these negative thoughts and emotions, the integrative therapy has great potential to reduce the depressive symptoms in caregivers and thus mitigate their perceived stress from BPSD. In addition, the interactive social dynamics in the dementia caregiving context can be improved.
Control group
Participants in the waitlist control group, in comparison to those in the intervention group who receive treatment immediately, are placed on a waiting list and receive the same set of intervention sessions after the formal trial. This approach ensures participants have equal opportunity to receive treatment while strengthening the study's validity and overall quality by maximally controlling for potential confounding variables and biases.
No interventions assigned to this group
Interventions
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Caregivers Of dementia Processing Emotions (COPE)
This is the first study to develop an easily accessible and feasible intervention programme, namely the Caregivers Of dementia Processing Emotions (COPE), to primarily reduce EE in family caregivers of PwD via processing one's attributional biases, dysregulated emotion, dysfunctional social dynamics using an integrative therapy. By displacing these negative thoughts and emotions, the integrative therapy has great potential to reduce the depressive symptoms in caregivers and thus mitigate their perceived stress from BPSD. In addition, the interactive social dynamics in the dementia caregiving context can be improved.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* (2) Provides care at least 4 hours per day
* (3) Consent to participate
* (4) No acute psychiatric illness
Exclusion Criteria
* (2) Provides care no more than 4 hours per day
* (3) Does not consent to participate
* (4) With acute psychiatric illness.
18 Years
100 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Prof. Yu, Doris Sau Fung
Proferssor
Locations
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University of Hong Kong
Hong Kong, , Hong Kong
Countries
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References
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Other Identifiers
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COPE
Identifier Type: -
Identifier Source: org_study_id