Alzheimer's Caregiver Coping: Mental and Physical Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Alzheimer's Caregiver Coping: Mental and Physical Health

Conditions
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Alzheimer Disease, Alzheimer Dementia, Alzheimer's Disease, Dementia

Intervention / Treatment
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* Behavioral: Behavioral Activation
* Behavioral: Information and Support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Activation<br>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<br>* Six face-to-face sessions (60 minutes each) of Behavioral Activation (BA) therapy<br>|
| Active Comparator: Information and Support<br>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<br>* Six face-to-face sessions (60 minutes each) of Supportive Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baroreflex Sensitivity (BRS) | Arterial function (baroreceptors) | Change from baseline to 2-year follow-up | 
| Arterial Compliance (AC) | Arterial function | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Caregiver, Cardiovascular Disease, Stress, Depression, Anxiety, Heart Disease, Carer, Care Giver, Caregiving, Psychotherapy, Therapy, Behavioral Activation, Education, Intervention, CBT, Cognitive-Behavior Therapy