BPSDNCT06359704
Intervention for Emotions in Caregivers of Dementia
A study testing Caregivers Of dementia Processing Emotions (COPE) program in people with BPSD and Expressed Emotion, run by The University of Hong Kong.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- BPSD, Expressed Emotion, Depressive Symptoms
- What is being tested?
- Caregivers Of dementia Processing Emotions (COPE) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
Read the 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
- Being tested
- Caregivers Of dementia Processing Emotions (COPE) program
- Keywords
- Dementia care, Caregiver burden, Integrative intervention
- Medical subject headings
- Depression, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregivers Of dementia Processing Emotions (COPE) programBehavioural
a dual-modal (face-to-face and online approaches), client-customized Caregivers Of dementia Processing Emotions (COPE) program
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to 3rd month followup
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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)
Measured: From baseline to 3rd month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPSDStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- controlled arm with waitlist treatment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuangzhou Chen, The University of Hong Kong
- Investigators
- Shuangzhou Chen, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359704
- Sponsor's protocol ID
- kevinszc
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Therapeutic Program to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia: a Pilot Randomized Controlled Trial: a Study Protocol
- ClinicalTrials.gov ID
- NCT06359704
- Acronym / sponsor ID
- kevinszc
- Conditions
- BPSD, Expressed Emotion, Depressive Symptoms
- Keywords
- Dementia care, Caregiver burden, Integrative intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- controlled arm with waitlist treatment
| Arm | Type | Receives |
|---|---|---|
| COPE program | Experimental | Behavioral: Caregivers Of dementia Processing Emotions (COPE) programa 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) |
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caregivers Of dementia Processing Emotions (COPE) programa dual-modal (face-to-face and online approaches), client-customized Caregivers Of dementia Processing Emotions (COPE) program | Behavioural | COPE program |
Primary outcome
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
3 secondary outcomes
depressive symptoms
Time frame: From baseline to 3rd month followup
social dynamics
Time frame: From baseline to 3rd month followup
BPSD
Time frame: From baseline to 3rd month followup
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuangzhou Chen, PhD principal investigator
The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Caregivers Of dementia Processing Emotions (COPE) program in people with BPSD and Expressed Emotion, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuangzhou Chen, PhD (852 3917 6395, szchen@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expressed emotions (time frame: From baseline to 3rd month followup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.