Dementia CaregiversNCT03552159
Behavioral Activation for Dementia Caregivers
A study testing Behavioral activation and Psychoeducation in people with Dementia Caregivers, run by The Hong Kong Polytechnic University.
Trial summary
This project was designed to test a model targeted intervention for dementia caregivers telephone program consisting of both psychoeducation and behavioral activation components to reduce the burden of caregivers. The program is delivered by telephone to increase accessibility and sustainability for caregivers. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia Caregivers
- What is being tested?
- Behavioral activation and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2012to 30 Jun 2016
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- They were caregivers aged 25 or above and must have be caring for a care recipient diagnosed with Alzheimer's disease for at least 3 months. They should be the primary caregiver and a spouse, kin (e.g. daughter/son or daughter/son-in-law) or sibling of the care recipient.
Who cannot join
- To ensure intervention fidelity, participants who showed signs of severe intellectual deficits, demonstrate suicidal ideation, exhibit evidence of psychotic disorders, or cannot read or speak fluent Chinese / Cantonese were excluded.
About this study
Official title: Behavioral Activation for Dementia Caregivers: Scheduling Pleasant Events and Enhancing Communications
This project was designed to test a model targeted intervention for dementia caregivers telephone program consisting of both psychoeducation and behavioral activation components to reduce the burden of caregivers. The program is delivered by telephone to increase accessibility and sustainability for caregivers.
Read the detailed description
The study compared two telephone interventions using a four-month longitudinal randomized controlled trial. For the first four weeks, all participants received the same psychoeducation program via telephone. Then for the following four months, eight biweekly telephone follow-up calls were carried out. For these eight follow-up calls, participants were randomized into either one of the two following groups with different conditions. For the Psychoeducation with BA (PsyED-BA) group, participants would receive eight biweekly sessions of BA practice focused on pleasant event scheduling and improving communications. For the Psychoeducation only (PsyED Only) group, there would be eight biweekly sessions of general discussion of psychoeducation and related information
- Conditions
- Dementia Caregivers
- Being tested
- Behavioral activation, Psychoeducation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral activationBehavioural
Activity scheduling, monitoring, review and re-scheduling
PsychoeducationOther
Education on dementia, caregiving stress, event scheduling and communication skills
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation | Experimental | For the first 4 weeks,participants received psychoeducation about the symptoms and associated behavioral changes of dementia and the possible effects on the caregivers, t the physical, social and psychological consequences of stress, event scheduling and communication skills. After psychoeducation, eight bi-weekly behavioral activation sessions were administered, focusing pleasant event scheduling and effective communications. Receives: Behavioral: Behavioral activation; Other: Psychoeducation |
| Psychoeducation | Active comparator | For the first 4 weeks, participants were taught about the symptoms and associated behavioral changes of dementia and the possible effects on the caregivers, the physical, social and psychological consequences of stress, event scheduling and communication skills. After psychoeducation, eight biweekly phone sessions of general support but not behavioral activation. Receives: Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms
Measured by CES-D
Measured: Change from baseline through study completion, an average of about 5 months
Secondary outcomes (1)
Sense of Burden
Measured by Zarit Burden Scale
Measured: Change from baseline through study completion, an average of about 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start1 Dec 2012
- Primary completion31 Dec 2015
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dementia CaregiversStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong, Stanford University, United Christian Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552159
- Sponsor's protocol ID
- HCPF2012
- Status last verified
- May 2018
- First submitted
- 30 May 2018
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.
PubMed 33417236Au A, Yip HM, Lai S, Ngai S, Cheng ST, Losada A, Thompson L, Gallagher-Thompson D. Telephone-based behavioral activation intervention for dementia family caregivers: Outcomes and mediation effect of a randomized controlled trial. Patient Educ Couns. 2019 Nov;102(11):2049-2059. doi: 10.1016/j.pec.2019.06.009. Epub 2019 Jun 26.
PubMed 31279613
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation for Dementia Caregivers: Scheduling Pleasant Events and Enhancing Communications
- ClinicalTrials.gov ID
- NCT03552159
- Acronym / sponsor ID
- HCPF2012
- Conditions
- Dementia Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The University of Hong Kong, Stanford University, United Christian Hospital
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 11 Jun 2018 (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 project was designed to test a model targeted intervention for dementia caregivers telephone program consisting of both psychoeducation and behavioral activation components to reduce the burden of caregivers. The program is delivered by telephone to increase accessibility and sustainability for caregivers.
Detailed description
The study compared two telephone interventions using a four-month longitudinal randomized controlled trial. For the first four weeks, all participants received the same psychoeducation program via telephone. Then for the following four months, eight biweekly telephone follow-up calls were carried out. For these eight follow-up calls, participants were randomized into either one of the two following groups with different conditions. For the Psychoeducation with BA (PsyED-BA) group, participants would receive eight biweekly sessions of BA practice focused on pleasant event scheduling and improving communications. For the Psychoeducation only (PsyED Only) group, there would be eight biweekly sessions of general discussion of psychoeducation and related information
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation | Experimental | Behavioral: Behavioral activation, Other: PsychoeducationFor the first 4 weeks,participants received psychoeducation about the symptoms and associated behavioral changes of dementia and the possible effects on the caregivers, t the physical, social and psychological consequences of stress, event scheduling and communication skills. After psychoeducation, eight bi-weekly behavioral activation sessions were administered, focusing pleasant event scheduling and effective communications. |
| Psychoeducation | Active comparator | Other: PsychoeducationFor the first 4 weeks, participants were taught about the symptoms and associated behavioral changes of dementia and the possible effects on the caregivers, the physical, social and psychological consequences of stress, event scheduling and communication skills. After psychoeducation, eight biweekly phone sessions of general support but not behavioral activation. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- They were caregivers aged 25 or above and must have be caring for a care recipient diagnosed with Alzheimer's disease for at least 3 months. They should be the primary caregiver and a spouse, kin (e.g. daughter/son or daughter/son-in-law) or sibling of the care recipient.
Key exclusion criteria (1 listed)
- To ensure intervention fidelity, participants who showed signs of severe intellectual deficits, demonstrate suicidal ideation, exhibit evidence of psychotic disorders, or cannot read or speak fluent Chinese / Cantonese were excluded.
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 |
|---|---|---|
| Behavioral activationActivity scheduling, monitoring, review and re-scheduling | Behavioural | Behavioral Activation |
| PsychoeducationEducation on dementia, caregiving stress, event scheduling and communication skills | Other | Behavioral Activation, Psychoeducation |
Primary outcome
Depressive Symptoms
Time frame: Change from baseline through study completion, an average of about 5 months
Measured by CES-D
1 secondary outcome
Sense of Burden
Time frame: Change from baseline through study completion, an average of about 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Derived from this study: PubMed 33417236Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.
- Derived from this study: PubMed 31279613Au A, Yip HM, Lai S, Ngai S, Cheng ST, Losada A, Thompson L, Gallagher-Thompson D. Telephone-based behavioral activation intervention for dementia family caregivers: Outcomes and mediation effect of a randomized controlled trial. Patient Educ Couns. 2019 Nov;102(11):2049-2059. doi: 10.1016/j.pec.2019.06.009. Epub 2019 Jun 26.
- Individual participant dataSharing planned: No
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Caregivers
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral activation and Psychoeducation in people with Dementia Caregivers, run by The Hong Kong Polytechnic University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Jun 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptoms (time frame: Change from baseline through study completion, an average of about 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03552159, which also lists 2 linked publications.
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 4 Jun 2019.