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

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03506945
• Other study ID #: 180454
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2023
• Source: University of California, San Diego
• Contact: Brent T Mausbach, PhD
• Phone: 8588227529
• Email: bmausbach[@]ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 31, 2024
• Est. primary completion date: July 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Stress, Psychological

Intervention

Behavioral:
• mPEP
Behavioral Activation Therapy
• Bibliotherapy
Provide educational material on coping strategies pertinent to caregivers

Locations

Country	Name	City	State
United States	University of California San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Center for Epidemiologic Studies Depression Scale--Revised (CESD-R)	20 item scale measuring Depressive Symptoms. Total Score will be used (Range = 0-60). Higher scores denote greater depressive symptoms.	15-months
Secondary	Positive and Negative Affect Scale (PANAS)	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.	15-months
Secondary	Blood Pressure	Systolic and Diastolic Blood Pressure	15-months
Secondary	SF-12	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.	15-months