Behavioral Activation for Dementia Caregivers

NCT ID: NCT03552159

Last Updated: 2019-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-01

Study Completion Date

2016-06-30

Brief Summary

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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

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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

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Dementia Caregivers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Behavioral activation

Intervention Type BEHAVIORAL

Activity scheduling, monitoring, review and re-scheduling

Psychoeducation

Intervention Type OTHER

Education on dementia, caregiving stress, event scheduling and communication skills

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.

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type OTHER

Education on dementia, caregiving stress, event scheduling and communication skills

Interventions

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Behavioral activation

Activity scheduling, monitoring, review and re-scheduling

Intervention Type BEHAVIORAL

Psychoeducation

Education on dementia, caregiving stress, event scheduling and communication skills

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

United Christian Hospital

OTHER

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 33417236 (View on PubMed)

Au 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.

Reference Type DERIVED
PMID: 31279613 (View on PubMed)

Other Identifiers

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HCPF2012

Identifier Type: -

Identifier Source: org_study_id

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