N/A
N=100
Reducing CVD Risk in Caregivers: A Brief Behavioral Activation Intervention
Depressive Symptoms · Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT01802554 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Brief Center for Epidemiologic Studies Depression Scale (CESD) — -3.46; -1.26 units on a scale — p=.039
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pleasant Events Program (PEP) (Behavioral); Information Support (IS) (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Center for Epidemiologic Studies Depression Scale (CESD) |
-3.46; -1.26 | .039 sig |
| PRIMARY D-dimer |
-92.22; -61.0 | .701 |
| PRIMARY Interleukin-6 (IL-6) |
-0.58; 1.33 | .04 sig |
| SECONDARY Positive and Negative Affect Schedule |
-3.43; -0.61 | .021 sig |
| SECONDARY Positive and Negative Affect Schedule |
-3.43; -0.61 | .021 sig |
Summary
Cardiovascular disease and depression are some of the most costly illnesses to society, and caring for a loved-one with Alzheimer's disease has been associated with increased risk for both depression and cardiovascular disease. Indeed, depressive symptoms have been linked with elevated plasma concentrations of D-dimer and Interleukin-6 (IL-6), both of which are associated with increased risk for cardiovascular disease (CVD). The present research tests a brief behavioral intervention for reducing both depressive symptoms and CVD biomarkers in Alzheimer caregivers. We hypothesize that caregivers receiving a brief Behavioral Activation (BA) therapy will show greater reductions in depressive symptoms and in CVD biomarkers relative to those randomized to a time-equivalent Information and Support (IS) therapy.
Eligibility Criteria
Inclusion Criteria
- Aged 55 or older and providing at-home care for a care recipient (CR) with a physician-diagnosis of Alzheimer's disease (AD) or related dementia.
Exclusion Criteria
- Receiving beta-blocking medications at enrollment
- Receiving treatment with Anticoagulant medications
- Severe hypertension (>200/120 mmHg)
- Diagnosed with a terminal illness with a life expectancy <6 months
- Enrolled in another intervention study
Data sourced from ClinicalTrials.gov (NCT01802554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.