University of California San Diego
La Jolla, California, 92093, United States
NCT Number: NCT02317523
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.
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Notify Me55 year and older
All sexes
Interventional
Not applicable
La Jolla, California, 92093, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Six face-to-face sessions (60 minutes each) of Behavioral Activation (BA) therapy
Six face-to-face sessions (60 minutes each) of Supportive Therapy
Time frame: Change from baseline to 2-year follow-up
Flow-Mediated Dilation
Time frame: Change from baseline to 2-year follow-up
Depressive Symptoms
Time frame: Change from baseline to 2-year follow-up
Inflammation (IL-6)
Time frame: Change from baseline to 2-year follow-up
Arterial function (baroreceptors)
Time frame: Change from baseline to 2-year follow-up
Arterial function
Time frame: Change from baseline to 2-year follow-up
Vascular outcome
Time frame: Change from baseline to 2-year follow-up
Coagulation
Time frame: Change from baseline to 2-year follow-up
Inflammation
Time frame: Change from baseline to 2-year follow-up
Biomarker
Time frame: Change from baseline to 2-year follow-up
Coagulation
Time frame: Change from baseline to 2-year follow-up
Coagulation
University of California, San Diego
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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