Intervention for Emotions in Caregivers of Dementia

NCT06359704 | Not Yet Recruiting

• 1 other identifier: kevinszc
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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).

Conditions

BPSD; Expressed Emotion; Depressive Symptoms

Keywords

Dementia care; Caregiver burden; Integrative intervention

Outcome Measures

Primary Outcomes (1)

• Expressed emotions

  Family Attitude Scale - Chinese version (FAS-C) will measure caregivers' EE (i.e., criticism and hostility) held towards the PLwD. FAS-C items are rated on a 5-point Likert scale, with higher scores indicating a higher level of EE.(Kavanagh et al., 1997; Van Humbeeck et al., 2002) Its Cronbach's alpha has been reported as 0.95, with evidence of good construct validity

  From baseline to 3rd month followup

Secondary Outcomes (3)

• depressive symptoms

  From baseline to 3rd month followup

• social dynamics

  From baseline to 3rd month followup

• BPSD

  From baseline to 3rd month followup

Study Arms (2)

COPE program

EXPERIMENTAL

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)

Behavioral: Caregivers Of dementia Processing Emotions (COPE) program

Waitlist control

NO INTERVENTION

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

Interventions

Caregivers Of dementia Processing Emotions (COPE) program BEHAVIORAL

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

COPE program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Conditions

Depression; Caregiver Burden

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress, Psychological

Study Officials

• Shuangzhou Chen, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuangzhou Chen, PhD

CONTACT

852 3917 6395; szchen@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post doctoral fellow/Principal Investigator

Model Details: controlled arm with waitlist treatment

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 11, 2024
• Study Start: June 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: February 1, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04