Intervention for Emotions in Caregivers of Dementia

NCT ID: NCT06359704

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-02-01

Brief Summary

This study aims to evaluate the effectiveness of a 6-week Caregivers Of dementia Processing Emotions (COPE) program using the integrative therapy to reduce EE (primary outcome) in family caregiver of PLwD to alleviate the caregivers' depression, improve social dynamic with the PLwD, and mitigate the perceived stress from BPSD (secondary outcomes).

Detailed Description

A dual-modal (face-to-face and online approaches), client-customized Caregivers Of dementia Processing Emotions (COPE) program can be developed to address EE in caregivers, such as (1) reduce caregivers' EE, (2) reduce caregivers' depressive symptoms, (3) reduce the behaviorally interactive social dynamic of maladaptation (i.e., dysfunctional dyadic relationship and quality of care), and (4) improve caregivers' perceived stress from PLwD's BPSD.

Conditions

BPSD; Expressed Emotion; Depressive Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

COPE program

a 6-week Caregivers Of dementia Processing Emotions (COPE) program using the integrative therapy to reduce EE (primary outcome) in family caregiver of PLwD to alleviate the caregivers' depression, improve social dynamic with the PLwD, and mitigate the perceived stress from BPSD (secondary outcomes)

Group Type: EXPERIMENTAL

Caregivers Of dementia Processing Emotions (COPE) program

Intervention Type: BEHAVIORAL

a dual-modal (face-to-face and online approaches), client-customized Caregivers Of dementia Processing Emotions (COPE) program

Waitlist control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Caregivers Of dementia Processing Emotions (COPE) program

a dual-modal (face-to-face and online approaches), client-customized Caregivers Of dementia Processing Emotions (COPE) program

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• with a high level of expressed emotion as indicated by a cut-off score of 35 or above on the Family Attitude Scale (Chinese version; FAS-C);(Kavanagh et al., 1997; Van Humbeeck et al., 2002; Yu et al., 2016)
• provides care at least 4 hours per day;(Moon & Adams, 2013)
• consent to participate, and
• no acute psychiatric illness.

Exclusion Criteria

• with a low level (scored lower than 35 on FAS-C) of expressed emotion
• do not provide consistent or sufficient care (fewer than 4 hours per day) to PLwD
• do not consent to participate;
• with comorbid acute psychiatric illness.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Shuangzhou Chen

Post doctoral fellow/Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shuangzhou Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Central Contacts

Shuangzhou Chen, PhD

Role: CONTACT

szchen@hku.hk

852 3917 6395

Other Identifiers

kevinszc

Identifier Type: -

Identifier Source: org_study_id