Reducing CVD Risk in Caregivers: A Brief Behavioral Activation Intervention

University of California San Diego

Status: Completed

Conditions: Depressive Symptoms; Inflammation

Treatments: Behavioral: Pleasant Events Program (PEP); Behavioral: Information Support (IS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01802554

R01AG031090

Details and patient eligibility

About

Cardiovascular disease and depression are some of the most costly illnesses to society, and caring for a loved-one with Alzheimer's disease has been associated with increased risk for both depression and cardiovascular disease. Indeed, depressive symptoms have been linked with elevated plasma concentrations of D-dimer and Interleukin-6 (IL-6), both of which are associated with increased risk for cardiovascular disease (CVD). The present research tests a brief behavioral intervention for reducing both depressive symptoms and CVD biomarkers in Alzheimer caregivers. We hypothesize that caregivers receiving a brief Behavioral Activation (BA) therapy will show greater reductions in depressive symptoms and in CVD biomarkers relative to those randomized to a time-equivalent Information and Support (IS) therapy.

Full description

Due to an aging society, the number of people diagnosed with dementia is expected to increase dramatically over the next two decades, with a concomitant rise in the number of family members providing informal care for their loved ones. The stresses associated with this care have been well-documented in the scientific literature, and are noted to be associated with increased risk for psychological and physical morbidity, particularly cardiovascular disease. Indeed, caregiving is associated with elevations in negative affect (e.g., depressive and anxiety symptoms), which in turn is associated with biological indicators that are thought to predict CVD risk (e.g., markers of coagulation and inflammation). The primary goal of this study is to examine the efficacy of a brief Behavioral Activation (BA) Treatment, called the Pleasant Events Program (PEP), for reducing biological CVD risk indicators in a sample of Alzheimer caregivers. We will enroll 100 dementia caregivers and randomly assign them to receive 4-sessions of PEP or 4-sessions of support + information. Our PEP intervention will be conducted in caregivers' homes and will emphasize the importance of monitoring and increasing activities that help individuals make contact with natural reinforcers in their environments, identifying and reducing negative coping responses, and selection and achievement of behavioral goals for healthier living. Caregivers will be assessed for our biological outcomes at baseline, post-treatment, and 1-year to determine intervention efficacy. Given the brief nature of the PEP intervention, the ease with which it can be applied in real-world settings (e.g., community agencies providing services to caregivers), and lack of difficult skills for interventionists and caregivers to acquire, we believe our PEP intervention will be easily transferred to "real-world" settings. If our PEP intervention is efficacious, it may have a considerable impact on both the physical and mental health of caregivers, and will likely have public health implications.

Enrollment: 100 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 55 or older and providing at-home care for a care recipient (CR) with a physician-diagnosis of Alzheimer's disease (AD) or related dementia.

Exclusion criteria

• Receiving beta-blocking medications at enrollment
• Receiving treatment with Anticoagulant medications
• Severe hypertension (>200/120 mmHg)
• Diagnosed with a terminal illness with a life expectancy <6 months
• Enrolled in another intervention study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Pleasant Events Program (PEP)

Experimental group

Description:

The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.

Treatment:

Behavioral: Pleasant Events Program (PEP)

Information-Support (IS)

Active Comparator group

Description:

Participants in the Information-Support (IS) control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Each IS session allowed caregivers to select issue(s) from the resource manual to discuss. The therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided.

Treatment:

Behavioral: Information Support (IS)