Clinical trial NCT02317523: Alzheimer's Caregiver Coping: Mental and Physical Health
Official title: Alzheimer's Caregiver Coping: Mental and Physical Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Alzheimer Dementia
Alzheimer's Disease
Dementia
Keywords: Dementia
Caregiver
Cardiovascular Disease
Stress
Depression
Anxiety
Heart Disease
Carer
Care Giver
Caregiving
Psychotherapy
Therapy
Behavioral Activation
Education
Intervention
CBT
Cognitive-Behavior Therapy
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-12-16
Enrollment: 151
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Endothelium-dependent Flow Mediated Dilation (FMD)
timeFrame: Change from baseline to 2-year follow-up
measure: Center for Epidemiologic Studies - Depression (CES-D) scale
timeFrame: Change from baseline to 2-year follow-up
measure: Interleukin-6
timeFrame: Change from baseline to 2-year follow-up
Secondary outcomes:
measure: Baroreflex Sensitivity (BRS)
timeFrame: Change from baseline to 2-year follow-up
measure: Arterial Compliance (AC)
timeFrame: Change from baseline to 2-year follow-up
measure: Carotid Intima Media Thickness (IMT)
timeFrame: Change from baseline to 2-year follow-up
measure: D-dimer
timeFrame: Change from baseline to 2-year follow-up
measure: C-reactive Protein (CRP)
timeFrame: Change from baseline to 2-year follow-up
measure: Tumor Necrosis Factor (TNF)- alpha
timeFrame: Change from baseline to 2-year follow-up
measure: Plasminogen Activator Inhibitor (PAI)-1
timeFrame: Change from baseline to 2-year follow-up
measure: von Willebrand Factor (vWF)
timeFrame: Change from baseline to 2-year follow-up
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Brent T Mausbach, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.