Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03506945
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Brent Mausbach, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Stress, Psychological Behavioral: mPEP Behavioral: Bibliotherapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mobile Web-based Behavioral Intervention for Improving Caregiver Well-being
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : July 28, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: mPEP
Behavioral Activation Therapy - Increase engagement in pleasant activities
Behavioral: mPEP
Behavioral Activation Therapy

Active Comparator: Bibliotherapy
Bibliotherapy - Develop improved coping and problem-solving skills
Behavioral: Bibliotherapy
Provide educational material on coping strategies pertinent to caregivers




Primary Outcome Measures :
  1. Center for Epidemiologic Studies Depression Scale--Revised (CESD-R) [ Time Frame: 15-months ]
    20 item scale measuring Depressive Symptoms. Total Score will be used (Range = 0-60). Higher scores denote greater depressive symptoms.


Secondary Outcome Measures :
  1. Positive and Negative Affect Scale (PANAS) [ Time Frame: 15-months ]
    10-item Positive Affect Subscale Score (Subscale Score Range = 10-50) and 10-item Negative Affect Subscale Score (Subscale Score Range = 10-50). Higher scores denote greater positive and negative affect, respectively.

  2. Blood Pressure [ Time Frame: 15-months ]
    Systolic and Diastolic Blood Pressure

  3. SF-12 [ Time Frame: 15-months ]
    Physical Composite Subscale Score (PCS) and Mental Composite Subscale Score..Scores on the PCS and MCS range from 0 to 100, where a zero score indicates the lowest level of health measured by the subscales and 100 indicates the highest level of health.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506945


Contacts
Layout table for location contacts
Contact: Brent T Mausbach, PhD 8588227529 bmausbach@ucsd.edu
Contact: Igor Grant, MD 8585436222 igrant@ucsd.edu

Locations
Layout table for location information
United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Brent Mausbach, PhD         
Principal Investigator: Brent Mausbach, PhD         
Sponsors and Collaborators
University of California, San Diego

Layout table for additonal information
Responsible Party: Brent Mausbach, Professor of Psychiatry, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03506945    
Other Study ID Numbers: 180454
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Stress, Psychological
Behavioral Symptoms