Mobile Web-based Behavioral Intervention for Improving Caregiver Well-being
2 other identifiers
interventional
184
1 country
1
Brief Summary
Caregivers suffer great amounts of distress that significantly impacts their mental and physical well-being, yet caregivers' access to quality, evidence-based care is currently very limited. The public health significance of the proposed study is that our internet and mobile-based web intervention will (1) significantly reduce caregiver distress and improve caregivers' overall well-being, and (2) dramatically increase caregivers' access to high quality, evidence-based care at relatively low cost.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2018
CompletedFirst Posted
Study publicly available on registry
April 24, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedResults Posted
Study results publicly available
October 24, 2025
CompletedOctober 24, 2025
September 1, 2025
5.6 years
April 6, 2018
September 22, 2025
September 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Center for Epidemiologic Studies Depression Scale--Revised (CESD-R)
20 item scale measuring Depressive Symptoms. Each item rated on a range of 0-4 and items are summed to create a total score (Range = 0-80). Higher scores denote greater depressive symptoms.
15-months
Secondary Outcomes (3)
Positive and Negative Affect Scale (PANAS)
15-months
Blood Pressure
15-months
Dementia Quality of Life Scale for Older Family Carers (DQoLOC)
15-months
Study Arms (2)
mPEP
EXPERIMENTALBehavioral Activation Therapy - Increase engagement in pleasant activities as a mechanism for reducing distress and improving overall well-being. Participants will use an online web tool to select and schedule activities they deem will be rewarding and fulfilling. They will then track their engagement in these activities on a weekly basis.
Bibliotherapy
ACTIVE COMPARATORBibliotherapy - Develop improved coping and problem-solving skills. Participants will receive bibliotherapy handouts describing various means of managing their distress and solving caregiving-related problems.
Interventions
Provide educational material on coping strategies pertinent to caregivers
Eligibility Criteria
You may qualify if:
- English-speaking
- Spouse or Child Caregiver of a loved-one with Alzheimer's Disease or Related Dementia (ADRD)
- Aged 40 years or older at the time of enrollment
- Providing at least 20 hours of in-home care per week
- Screening positive for mild depressive symptoms (CESD-R≥16).
You may not qualify if:
- Diagnosed with a terminal illness
- Demonstrates cognitive impairment (MMSE\<27)
- Severe hypertension (\>200/120 mm Hg)
- Participating in another active caregiver intervention (other than support groups)
- Receiving psychiatric care for serious mental illnesses such as schizophrenia or bipolar disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California San Diego
La Jolla, California, 92093, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brent Mausbach
- Organization
- University of California San Diego
Study Officials
- PRINCIPAL INVESTIGATOR
Brent T Mausbach, PhD
University of California, San Diego
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
April 6, 2018
First Posted
April 24, 2018
Study Start
November 1, 2018
Primary Completion
May 31, 2024
Study Completion
May 31, 2024
Last Updated
October 24, 2025
Results First Posted
October 24, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Within 12 months of close of the trial
- Access Criteria
- The PI will determine who is authorized to have copies of what types of data and when the data will be available. Publicizing availability of the data after main results from the study have been published, and providing a USB or CD containing the data to individuals who express interest, will ensure that maximum data sharing occurs.
Research data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers. The PI will determine who is authorized to have copies of what types of data and when the data will be available. Publicizing availability of the data after main results from the study have been published, and providing a USB or CD containing the data to individuals who express interest, will ensure that maximum data sharing occurs. We will make the data and associated documentation available to users under a data-sharing agreement that provides for: (1) a commitment to use the data only for research purposes and not to identify any individual participant; (2) a commitment to secure the data using appropriate computer technology; and (3) a commitment to destroy or return the data after analyses are completed.