NCT03552159|Completed
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Sponsor study identifier
interventional
96
0 countries
N/A
Study Start
December 1, 2012
Actual (reported)Primary Completion
December 31, 2015
Actual (reported)Study Completion
June 30, 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2012
Actual (reported)December 31, 2015
Actual (reported)June 30, 2016
Actual (reported)May 30, 2018
Actual (reported)June 11, 2018
Actual (reported)Depressive Symptoms
Measured by CES-D
Change from baseline through study completion, an average of about 5 months
Sense of Burden
Change from baseline through study completion, an average of about 5 months
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.
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.
Activity scheduling, monitoring, review and re-scheduling
Education on dementia, caregiving stress, event scheduling and communication skills
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.
96 participants (actual enrollment reported by the registry).
First Submitted
May 30, 2018
First Posted
June 11, 2018
Study Start
December 1, 2012
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2015
Actual (reported)Study Completion
June 30, 2016
Actual (reported)Last Updated
June 4, 2019
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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