Clinical trial NCT03506945: Mobile Web-based Behavioral Intervention for Improving Caregiver Well-being
Official title: Mobile Web-based Behavioral Intervention for Improving Caregiver Well-being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Stress, Psychological
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 184
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Center for Epidemiologic Studies Depression Scale--Revised (CESD-R)
timeFrame: 15-months
Secondary outcomes:
measure: Positive and Negative Affect Scale (PANAS)
timeFrame: 15-months
measure: Blood Pressure
timeFrame: 15-months
measure: SF-12
timeFrame: 15-months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Brent T Mausbach, PhD
role: PRINCIPAL_INVESTIGATOR
References: