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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07305415
Acronym
COPE
Enrollment
56
Registered
2025-12-26
Start date
2025-12-20
Completion date
2027-03-30
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BPSD (Behavioral and Psycological Symptoms of Dementia), Caregiving Stress, Depressive Symptom, Expressed Emotion

Keywords

BPSD, behavioral and psychological symptoms of dementia, Expressed Emotion, Dementia caregivers, Dementia caregiving, preceived stress, caregiver depression, caregiving stress, caregiving relationship, dyadic care relationship

Brief 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

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.

Interventions

BEHAVIORALCaregivers 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.

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Family Attitude Scale- Chinese VersionFrom 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.

Secondary

MeasureTime frameDescription
Center of Epidemiological Studies of Depression Revised - Chinese VersionFrom enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.Assess caregivers' depression
Dyadic Relationship Scale - Chinese VersionFrom 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
Interaction Quality Scale - Chinese VersionFrom enrollment to the end of intervention at 7 weeks and end of study at 20 weeks.Measure the quality of care.
Neuropsychiatric Inventory - Chinese VersionFrom 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.

Countries

Hong Kong

Contacts

CONTACTDoris Sau Fung YU, PhD
dyu1@hku.hk+852 39176319
PRINCIPAL_INVESTIGATORDoris Sau Fung YU, PhD

The University of Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026