Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia (COPE)

March 25, 2026 updated by: Prof. Yu, Doris Sau Fung, The University of Hong Kong

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: YU Sau Fung, RN, PhD, FHKAN, FAAN, FGSA
  • Phone Number: 852 + 39176319
  • Email: dyu1@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • University of Hong Kong
        • Contact:
          • YU Sau Fung
          • Phone Number: 852 + 39176319
          • Email: dyu1@hku.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • COPE
  • Mindfulness and Cognitive Behavioral Therapy
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.
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.
Other Names:
  • COPE
  • Mindfulness and Cognitive Behavioral Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family Attitude Scale- Chinese Version
Time Frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Measure caregivers' expressed emotions (EE) (i.e., criticism and hostility) held towards the PwD.
From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Center of Epidemiological Studies of Depression Revised - Chinese Version
Time Frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Assess caregivers' depression
From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Dyadic Relationship Scale - Chinese Version
Time Frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Evaluate caregivers' perspective of dyadic and family relationships in their daily caregiving activities
From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Interaction Quality Scale - Chinese Version
Time Frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Measure the quality of care.
From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Neuropsychiatric Inventory - Chinese Version
Time Frame: From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.
Assess the severity of BPSD manifested in PwD reported by their caregivers.
From enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

December 12, 2025

First Submitted That Met QC Criteria

December 12, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COPE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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