Alzheimer Dementia, Alzheimer Disease, Alzheimer's Disease, Dementia
Conditions
Keywords
Dementia, Caregiver, Cardiovascular Disease, Stress, Depression, Anxiety, Heart Disease, Carer, Care Giver, Caregiving, Psychotherapy, Therapy, Behavioral Activation, Education, Intervention, CBT, Cognitive-Behavior Therapy
Brief summary
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
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.
Interventions
BEHAVIORALBehavioral Activation
Six face-to-face sessions (60 minutes each) of Behavioral Activation (BA) therapy
BEHAVIORALInformation and Support
Six face-to-face sessions (60 minutes each) of Supportive Therapy
Sponsors
National Institute on Aging (NIA)
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelium-dependent Flow Mediated Dilation (FMD) | Change from baseline to 2-year follow-up | Flow-Mediated Dilation |
| Center for Epidemiologic Studies - Depression (CES-D) scale | Change from baseline to 2-year follow-up | Depressive Symptoms |
| Interleukin-6 | Change from baseline to 2-year follow-up | Inflammation (IL-6) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| D-dimer | Change from baseline to 2-year follow-up | Coagulation |
| C-reactive Protein (CRP) | Change from baseline to 2-year follow-up | Inflammation |
| Baroreflex Sensitivity (BRS) | Change from baseline to 2-year follow-up | Arterial function (baroreceptors) |
| Plasminogen Activator Inhibitor (PAI)-1 | Change from baseline to 2-year follow-up | Coagulation |
| von Willebrand Factor (vWF) | Change from baseline to 2-year follow-up | Coagulation |
| Tumor Necrosis Factor (TNF)- alpha | Change from baseline to 2-year follow-up | Biomarker |
| Arterial Compliance (AC) | Change from baseline to 2-year follow-up | Arterial function |
| Carotid Intima Media Thickness (IMT) | Change from baseline to 2-year follow-up | Vascular outcome |
Countries
United States
Outcome results
None listed