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| ID | Type | Description | Link |
|---|---|---|---|
| RF1AG015301 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Activation | Experimental | 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. |
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| Information and Support | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation | Behavioral | Six face-to-face sessions (60 minutes each) of Behavioral Activation (BA) therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Endothelium-dependent Flow Mediated Dilation (FMD) | Flow-Mediated Dilation | Change from baseline to 2-year follow-up |
| Center for Epidemiologic Studies - Depression (CES-D) scale | Depressive Symptoms | Change from baseline to 2-year follow-up |
| Interleukin-6 | Inflammation (IL-6) | Change from baseline to 2-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Baroreflex Sensitivity (BRS) | Arterial function (baroreceptors) | Change from baseline to 2-year follow-up |
| Arterial Compliance (AC) | Arterial function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brent T Mausbach, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30669980 | Derived | von Kanel R, Mausbach BT, Dimsdale JE, Ziegler MG, Mills PJ, Allison MA, Patterson TL, Ancoli-Israel S, Grant I. Refining caregiver vulnerability for clinical practice: determinants of self-rated health in spousal dementia caregivers. BMC Geriatr. 2019 Jan 22;19(1):18. doi: 10.1186/s12877-019-1033-2. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D002318 | Cardiovascular Diseases |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Information and Support | Behavioral | Six face-to-face sessions (60 minutes each) of Supportive Therapy |
|
| Change from baseline to 2-year follow-up |
| Carotid Intima Media Thickness (IMT) | Vascular outcome | Change from baseline to 2-year follow-up |
| D-dimer | Coagulation | Change from baseline to 2-year follow-up |
| C-reactive Protein (CRP) | Inflammation | Change from baseline to 2-year follow-up |
| Tumor Necrosis Factor (TNF)- alpha | Biomarker | Change from baseline to 2-year follow-up |
| Plasminogen Activator Inhibitor (PAI)-1 | Coagulation | Change from baseline to 2-year follow-up |
| von Willebrand Factor (vWF) | Coagulation | Change from baseline to 2-year follow-up |
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |