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Behavioral Activation for Dementia Caregivers

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ClinicalTrials.gov Identifier: NCT03552159
Recruitment Status : Completed
First Posted : June 11, 2018
Last Update Posted : June 4, 2019
Sponsor:
Collaborators:
The University of Hong Kong
Stanford University
United Christian Hospital
Information provided by (Responsible Party):
The Hong Kong Polytechnic University

Brief 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.

Condition or disease Intervention/treatment Phase
Dementia Caregivers Behavioral: Behavioral activation Other: Psychoeducation Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Activation for Dementia Caregivers: Scheduling Pleasant Events and Enhancing Communications
Actual Study Start Date : December 1, 2012
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: Behavioral Activation
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.
Behavioral: Behavioral activation
Activity scheduling, monitoring, review and re-scheduling

Other: Psychoeducation
Education on dementia, caregiving stress, event scheduling and communication skills

Active Comparator: Psychoeducation
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.
Other: Psychoeducation
Education on dementia, caregiving stress, event scheduling and communication skills




Primary Outcome Measures :
  1. Depressive Symptoms [ Time Frame: Change from baseline through study completion, an average of about 5 months ]
    Measured by CES-D


Secondary Outcome Measures :
  1. Sense of Burden [ Time Frame: Change from baseline through study completion, an average of about 5 months ]
    Measured by Zarit Burden Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.


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Responsible Party: The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03552159     History of Changes
Other Study ID Numbers: HCPF2012
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders