Mobile Web-based Behavioral Intervention for Improving Caregiver Well-being

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.

Study Overview

• Status: Completed
• Conditions: Stress, Psychological; Depressive Symptoms
• Intervention / Treatment: Behavioral: mPEP; Behavioral: Bibliotherapy

Detailed Description

Over 15 million men and women provide informal caregiving services to family members who have dementia. The literature is replete with evidence that caregiving results in high rates of depression and distress, and potentially high rates of physical morbidity. For example, 40% of caregivers are at risk for depression compared to just 5% of non-caregiving older adults. Further, increased symptoms of depression and distress in caregivers are associated with accelerated risk for developing cardiovascular disease. Thus, efficacious interventions for reducing caregiver distress appear potentially valuable for both mental and physical well-being.

Given the distress experienced by caregivers, it is no surprise that over 80 intervention studies for reducing caregiver distress have been published. The message from these studies is that caregiver interventions, in general, are effective for reducing distress. Yet, the implementation of Evidence Based Treatments (EBTs) continues to be a challenge. Despite identification of EBTs, their use at the community-level has been absent. In 2007, NIH sponsored a workshop on the use of EBTs for caregivers. The conclusion was that "The majority of effective interventions for caregivers were not being implemented through the aging network." Ten years later, this lack of implementation remains. It is critical that scientists develop interventions for caregivers with maximal reach and minimal cost. Currently, most caregiver intervention frameworks require caregivers to meet with a therapist in one of four formats: a) face-to-face meetings with a therapist outside the caregiver's home, b) face-to-face meetings with a therapist in the caregiver's home, c) in-person, group-based meetings, or d) phone-based interventions in which caregivers call a therapist or support group. While possibly efficacious, these therapeutic formats are limited because: a) community agencies serving caregivers do not offer EBTs, b) the interventions are often not accessible to caregivers who reside outside the care network, c) they require caregivers to attend therapy sessions on specific days and times that may not be convenient for them, or d) they may require caregivers to find alternate care for their care recipients while they attend the therapy. To address these limitations, the investigators have adapted an evidence-based, brief Behavioral Activation (BA) program to be delivered to caregivers via mobile phones with internet-based capabilities, thereby increasing caregivers' access to quality care. This mobile intervention is now being tested in this full-scale trial. The investigators will test mechanisms of action, namely that increased behavioral activation promotes well-being in caregivers. To do so, the investigators will recruit and randomize 200 caregivers to receive either a mobile BA intervention (N = 100) known as the mobile pleasant events program (mPEP), or a web-based bibliotherapy condition (N = 100) teaching skills on coping with caregiving. Participants will be assessed for depressive symptoms, positive and negative affect, well-being, and blood pressure at baseline, 3-months, 9-months, and 15-months follow-up time points.

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University of California San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria -

• 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).

Exclusion Criteria -

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mPEP; Behavioral 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.	Behavioral: mPEP; Behavioral Activation Therapy
Active Comparator: Bibliotherapy; Bibliotherapy - Develop improved coping and problem-solving skills. Participants will receive bibliotherapy handouts describing various means of managing their distress and solving caregiving-related problems.	Behavioral: Bibliotherapy; Provide educational material on coping strategies pertinent to caregivers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Systolic and Diastolic Blood Pressure	15-months
Positive and Negative Affect Scale (PANAS)	Positive and Negative Affect Scale (PANAS). There are 10 items asking about Positive Affect, each item is rated on a range of 1-5. All 10 items are summed to create a total score (Range = 10-50) There are 10 items asking about Negative Affect, each item is rated from 1-5, and items are summed to create an overall score (Range = 10-50). Higher scores denote greater positive and negative affect, respectively.	15-months
Dementia Quality of Life Scale for Older Family Carers (DQoLOC)	Dementia Quality of Life Scale for Older Family Carers (DQoLOC). Scale consists of 22 items, each item is rated from 1-5. The total range for the scale is 22-110, with higher score indicating greater quality of life.	15-months

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Brent T Mausbach, PhD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Estimated): October 24, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression; Stress, Psychological; Therapeutics; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Bibliotherapy
• Other Study ID Numbers: 180454; R01AG061941 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Within 12 months of close of the trial
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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