Intervention for Emotions in Caregivers of Dementia

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Depressive Symptoms; BPSD; Expressed Emotion
• Intervention / Treatment: Behavioral: Caregivers Of dementia Processing Emotions (COPE) program

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.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shuangzhou Chen, PhD; Phone Number: 852 3917 6395; Email: szchen@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Behavioral: 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
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
depressive symptoms	The 20-item The Centre for Epidemiologic Studies Depression (CES-D) will assess caregivers' depression, with higher scores representing greater depressive levels on a 4-point scale.(Radloff, 1977) Its internal consistency Cronbach's alpha is 0.88 in the Chinese population, while its internal reliability is 0.91 and with evidence of construct validity.(Sebern & Whitlatch, 2007; Y. Zhang et al., 2015)	From baseline to 3rd month followup
social dynamics	Social dynamics will be measured in the aspects of dyadic relationships and quality of care. First, the 11-item Dyadic Relationship Scale (DRS) will evaluate caregivers' perspective of dyadic and family relationships in their daily caregiving activities, with a higher score indicating positive dyadic interactions; and Cronbach's alpha of 0.89 with desirable construct validity and concurrent validity.(Sebern & Whitlatch, 2007) Second, the 4-item Interaction Quality Scale (IQS) will measure the quality of care on a 6-point Likert scale, with a higher score indicating better quality of care.(Cundiff et al., 2016) IQS has desirable test-retest reliability (Cronbach's alpha = 0.96) and construct validity.(Joseph et al., 2014)	From baseline to 3rd month followup
BPSD	The 12-item Neuropsychiatric Inventory (NPI) will assess the severity of BPSD manifested in PLwD reported by their caregivers.(Cummings, 1997) NPI comprises three levels, with higher scores indicating severer BPSD symptoms. Its test-retest reliability was 0.79 for the overall scale, and between 0.89 and 0.93 for subdomains.(Chen et al., 2018; Cummings, 1997)	From baseline to 3rd month followup

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Shuangzhou Chen, PhD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: April 8, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Caregiver burden; Dementia care; Integrative intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Depression; Dementia
• Other Study ID Numbers: kevinszc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No