Behavioral Activation for Dementia Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Dementia Caregivers
• Intervention / Treatment: Behavioral: Behavioral activation; Other: Psychoeducation

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms	Measured by CES-D	Change from baseline through study completion, an average of about 5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sense of Burden	Measured by Zarit Burden Scale	Change from baseline through study completion, an average of about 5 months

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: The University of Hong Kong; Stanford University; United Christian Hospital

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): June 30, 2016

Study Registration Dates

• First Submitted: May 30, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (Actual): June 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 4, 2019
• Last Update Submitted That Met QC Criteria: June 2, 2019
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: HCPF2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No