Behavioral Activation for Dementia Caregivers

NCT03552159 | Completed

• 1 other identifier: HCPF2012
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dementia Caregivers

Outcome Measures

Primary Outcomes (1)

• Depressive Symptoms

  Measured by CES-D

  Change from baseline through study completion, an average of about 5 months

Secondary Outcomes (1)

• Sense of Burden

  Change from baseline through study completion, an average of about 5 months

Study Arms (2)

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.

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.

Other: Psychoeducation

Interventions

Behavioral activation BEHAVIORAL

Activity scheduling, monitoring, review and re-scheduling

Behavioral Activation

Psychoeducation OTHER

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

Behavioral Activation; Psychoeducation

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• The University of Hong Kong: collaborator
• Stanford University: collaborator
• United Christian Hospital: collaborator

Related Publications (2)

• 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.

  PMID: 33417236 DERIVED

• 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.

  PMID: 31279613 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 11, 2018
• Study Start: December 1, 2012
• Primary Completion: December 31, 2015
• Study Completion: June 30, 2016
• Last Updated: June 4, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share