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

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: BPSD (Behavioral and Psycological Symptoms of Dementia); Depressive Symptom; Expressed Emotion; Caregiving Stress

Treatments: Behavioral: Caregivers Of dementia Processing Emotions (COPE)

Study type: Interventional

Funder types: Other

Identifiers

NCT07305415

COPE

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

COPE Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Caregivers Of dementia Processing Emotions (COPE)

Control group

No Intervention group

Description:

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.