Intervention for Emotions in Caregivers of Dementia

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06359704
• Other study ID #: kevinszc
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: April 2024
• Source: The University of Hong Kong
• Contact: Shuangzhou Chen, PhD
• Phone: 852 3917 6395
• Email: szchen[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: February 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• BPSD
• Dementia
• Depression
• Depressive Symptoms
• Expressed Emotion

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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