An interventional study of Caregivers Of dementia Processing Emotions (COPE) in BPSD (Behavioral and Psycological Symptoms of Dementia), Expressed Emotion and Depressive Symptom, sponsored by The University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
The dual-modal (face-to-face and online approaches), client-customized Caregivers Of dementia Processing Emotions (COPE) programme aims to
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
Primary Purpose Prevention: Assessing the effectiveness of a novel intervention for preventing the development of negative outcomes in caregivers as a result of managing behavioral psychological symptoms of dementia.
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.
1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.
This study's planned enrollment of 56 is below the median of 120 across 1,197 interventional studies indexed under Behavior.
Browse Behavior studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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. The group size of 4 is used to optimize the social interactions between the peer and to facilitate their self-reflection and disclosure on their social interaction with the care recipients in day-to-day caregiving.
Behavioral: Caregivers Of dementia Processing Emotions (COPE)
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.
Behavioral: 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 expressed emotion (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.
Also known as: COPE, Mindfulness and Cognitive Behavioral Therapy
Family Attitude Scale- Chinese Version
Measure caregivers' expressed emotions (EE) (i.e., criticism and hostility) held towards the PwD.
Time frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Center of Epidemiological Studies of Depression Revised - Chinese Version
Assess caregivers' depression
Time frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Dyadic Relationship Scale - Chinese Version
Evaluate caregivers' perspective of dyadic and family relationships in their daily caregiving activities
Time frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Interaction Quality Scale - Chinese Version
Measure the quality of care.
Time frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Neuropsychiatric Inventory - Chinese Version
Assess the severity of BPSD manifested in PwD reported by their caregivers.
Time frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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