Behavioral Activation for Dementia Caregivers

Sponsor

The Hong Kong Polytechnic University (Other)

Overall Status

Completed

CT.gov ID

NCT03552159

Collaborator

The University of Hong Kong (Other), Stanford University (Other), United Christian Hospital (Other)

Enrollment

Arms

42.9

Actual Duration (Months)

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

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 :

Dec 1, 2012

Actual Primary Completion Date :

Dec 31, 2015

Actual Study Completion Date :

Jun 30, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Depressive Symptoms [Change from baseline through study completion, an average of about 5 months]
Measured by CES-D

Secondary Outcome Measures

Sense of Burden [Change from baseline through study completion, an average of about 5 months]
Measured by Zarit Burden Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The Hong Kong Polytechnic University
The University of Hong Kong
Stanford University
United Christian Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Hong Kong Polytechnic University

ClinicalTrials.gov Identifier:

NCT03552159

Other Study ID Numbers:

HCPF2012

First Posted:

Jun 11, 2018

Last Update Posted:

Jun 4, 2019

Last Verified:

May 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dementia

Study Results

No Results Posted as of Jun 4, 2019