Alzheimer's Caregiver Coping: Mental and Physical Health

University of California San Diego

Status: Completed

Conditions: Alzheimer Dementia; Alzheimer's Disease; Alzheimer Disease; Dementia

Treatments: Behavioral: Behavioral Activation; Behavioral: Information and Support

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02317523

RF1AG015301 (U.S. NIH Grant/Contract)

BMausbach

Details and patient eligibility

About

This study evaluates the effectiveness of Behavioral Activation (BA) therapy vs Support and Information for reducing risk for emotional and cardiovascular diseases in Alzheimer's caregivers. Half of participants will receive BA and the other half will receive support and information.

Full description

The burden of caring for a loved-one with Alzheimer's disease is associated with adverse psychological and general health consequences for the caregiver. These consequences including risk for depression, cardiovascular disease, and earlier mortality. Because preliminary work has demonstrated that an educational programs for caregivers reduce the negative affect associated with caregiving, the investigators wish to determine whether improving mood can also modify pathophysiological changes that have been linked to risk for developing cardiovascular disease.

The investigators aims are to determine whether a 6-week Behavioral Activation (BA) intervention, followed by 3 booster sessions over a period of 6 months, compared to an Information-Support (IS) intervention will be associated with significant improvement in indicators of vascular pathology, modification of psychobiological markers that have been associated with cardiovascular parameters, and to determine whether improvements in indicators of vascular parameters will be mediated by treatment related change in measures of distress and markers of cardiovascular disease risk.

Enrollment: 151 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 55 years or older.
• Providing in-home care to a spouse with dementia.

Exclusion criteria

• Taking Coumarin anticoagulants.
• Taking nitrates or niacin.
• Taking non-selective β-blockers.
• Glucocorticoid use in the 2 weeks prior to enrollment.
• Taking Aldomet or labetalol.
• Neither the caregiver nor Alzheimer's patient can be diagnosed with a terminal illness with a life expectancy of less than 1 year
• Cognitive impairment
• Caregivers enrolled in another intervention study or receiving psychotherapy to improve well-being or reduce distress
• Blood pressure >200/120 mm Hg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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151 participants in 2 patient groups

Behavioral Activation

Experimental group

Description:

Behavioral Activation (BA) emphasize self-monitoring as an aid for increasing one's engagement in self-reinforcing activities while simultaneously reducing negative avoidant coping responses. The intervention consists of 6 total face-to-face sessions lasting 60 minutes each.

Treatment:

Behavioral: Behavioral Activation

Information and Support

Active Comparator group

Description:

Information and Support (IS) consists of providing education on Alzheimer's disease, coping with specific stresses prevalent in caregiving, and community-based services available for caregivers. Caregivers choose information most relevant to their current circumstances, and can discuss this with their counselor during the sessions. In addition, the IS condition encompasses elements of supportive therapy including empathy and active listening. The intervention consists of 6 total face-to-face sessions lasting 60 minutes each.

Treatment:

Behavioral: Information and Support