Clinical trial NCT03552159: Behavioral Activation for Dementia Caregivers
Official title: Behavioral Activation for Dementia Caregivers: Scheduling Pleasant Events and Enhancing Communications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia Caregivers
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
name: Stanford University
name: United Christian Hospital
First posted: 2018-06-11
Enrollment: 96
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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.

Primary outcomes:
measure: Depressive Symptoms
timeFrame: Change from baseline through study completion, an average of about 5 months
Secondary outcomes:
measure: Sense of Burden
timeFrame: Change from baseline through study completion, an average of about 5 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.