Alzheimer’s Caregiver Coping: Mental and Physical Health

Overview

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 Title of Study: “Alzheimer’s Caregiver Coping: Mental and Physical Health”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2019

Detailed 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.

Interventions

  • Behavioral: Behavioral Activation
    • Six face-to-face sessions (60 minutes each) of Behavioral Activation (BA) therapy
  • Behavioral: Information and Support
    • Six face-to-face sessions (60 minutes each) of Supportive Therapy

Arms, Groups and Cohorts

  • Experimental: Behavioral Activation
    • 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.
  • Active Comparator: Information and Support
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Endothelium-dependent Flow Mediated Dilation (FMD)
    • Time Frame: Change from baseline to 2-year follow-up
    • Flow-Mediated Dilation
  • Center for Epidemiologic Studies – Depression (CES-D) scale
    • Time Frame: Change from baseline to 2-year follow-up
    • Depressive Symptoms
  • Interleukin-6
    • Time Frame: Change from baseline to 2-year follow-up
    • Inflammation (IL-6)

Secondary Measures

  • Baroreflex Sensitivity (BRS)
    • Time Frame: Change from baseline to 2-year follow-up
    • Arterial function (baroreceptors)
  • Arterial Compliance (AC)
    • Time Frame: Change from baseline to 2-year follow-up
    • Arterial function
  • Carotid Intima Media Thickness (IMT)
    • Time Frame: Change from baseline to 2-year follow-up
    • Vascular outcome
  • D-dimer
    • Time Frame: Change from baseline to 2-year follow-up
    • Coagulation
  • C-reactive Protein (CRP)
    • Time Frame: Change from baseline to 2-year follow-up
    • Inflammation
  • Tumor Necrosis Factor (TNF)- alpha
    • Time Frame: Change from baseline to 2-year follow-up
    • Biomarker
  • Plasminogen Activator Inhibitor (PAI)-1
    • Time Frame: Change from baseline to 2-year follow-up
    • Coagulation
  • von Willebrand Factor (vWF)
    • Time Frame: Change from baseline to 2-year follow-up
    • Coagulation

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, San Diego
  • Collaborator
    • National Institute on Aging (NIA)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Brent Mausbach, Associate Professor – University of California, San Diego
  • Overall Official(s)
    • Brent T Mausbach, PhD, Principal Investigator, University of California, San Diego

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