Alzheimer's Caregiver Coping: Mental and Physical Health

Not Applicable

Completed

• Conditions: Dementia; Alzheimer Disease; Alzheimer Dementia; Alzheimer's Disease
• Interventions: Behavioral: Behavioral Activation; Behavioral: Information and Support

• Registration Number: NCT02317523
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-15
• Study First Posted: 2014-12-16
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Activation	Behavioral Activation	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.
Information and Support	Information and Support	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.

Primary Outcome Measures

Name	Time	Method
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)
Endothelium-dependent Flow Mediated Dilation (FMD)	Change from baseline to 2-year follow-up	Flow-Mediated Dilation

Secondary Outcome Measures

Name	Time	Method
Carotid Intima Media Thickness (IMT)	Change from baseline to 2-year follow-up	Vascular outcome
D-dimer	Change from baseline to 2-year follow-up	Coagulation
C-reactive Protein (CRP)	Change from baseline to 2-year follow-up	Inflammation
Tumor Necrosis Factor (TNF)- alpha	Change from baseline to 2-year follow-up	Biomarker
Baroreflex Sensitivity (BRS)	Change from baseline to 2-year follow-up	Arterial function (baroreceptors)
Arterial Compliance (AC)	Change from baseline to 2-year follow-up	Arterial function
von Willebrand Factor (vWF)	Change from baseline to 2-year follow-up	Coagulation
Plasminogen Activator Inhibitor (PAI)-1	Change from baseline to 2-year follow-up	Coagulation

Trial Locations

Locations (1)

University of California San Diego; 🇺🇸 La Jolla, California, United States