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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
151
Six face-to-face sessions (60 minutes each) of Behavioral Activation (BA) therapy
Six face-to-face sessions (60 minutes each) of Supportive Therapy
University of California San Diego
La Jolla, California, United States
Endothelium-dependent Flow Mediated Dilation (FMD)
Flow-Mediated Dilation
Time frame: Change from baseline to 2-year follow-up
Center for Epidemiologic Studies - Depression (CES-D) scale
Depressive Symptoms
Time frame: Change from baseline to 2-year follow-up
Interleukin-6
Inflammation (IL-6)
Time frame: Change from baseline to 2-year follow-up
Baroreflex Sensitivity (BRS)
Arterial function (baroreceptors)
Time frame: Change from baseline to 2-year follow-up
Arterial Compliance (AC)
Arterial function
Time frame: Change from baseline to 2-year follow-up
Carotid Intima Media Thickness (IMT)
Vascular outcome
Time frame: Change from baseline to 2-year follow-up
D-dimer
Coagulation
Time frame: Change from baseline to 2-year follow-up
C-reactive Protein (CRP)
Inflammation
Time frame: Change from baseline to 2-year follow-up
Tumor Necrosis Factor (TNF)- alpha
Biomarker
Time frame: Change from baseline to 2-year follow-up
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Plasminogen Activator Inhibitor (PAI)-1
Coagulation
Time frame: Change from baseline to 2-year follow-up
von Willebrand Factor (vWF)
Coagulation
Time frame: Change from baseline to 2-year follow-up