An interventional study of Behavioral Activation and Information and Support in Alzheimer Disease, Alzheimer Dementia and Alzheimer's Disease, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2019-09-26.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 151 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Behavioral Activation
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.
Behavioral: Information and Support
Six face-to-face sessions (60 minutes each) of Behavioral Activation (BA) therapy
Six face-to-face sessions (60 minutes each) of Supportive Therapy
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
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
Plan to share: Undecided
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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University of California, San Diego