Intervention for Emotions in Caregivers of Dementia

April 10, 2024 updated by: Shuangzhou Chen, The University of Hong Kong

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Shuangzhou Chen, PhD
  • Phone Number: 852 3917 6395
  • Email: szchen@hku.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Expressed emotions
Time Frame: From baseline to 3rd month followup
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
depressive symptoms
Time Frame: From baseline to 3rd month followup
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
Time Frame: From baseline to 3rd month followup
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
Time Frame: From baseline to 3rd month followup
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shuangzhou Chen, PhD, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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