Alzheimer's Caregiver Coping: Mental and Physical Health

Alzheimer Disease Clinical Trial

Official title:

Alzheimer's Caregiver Coping: Mental and Physical Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317523
• Other study ID #: BMausbach
• Secondary ID: RF1AG015301
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Alzheimer Dementia
• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

Behavioral:
• Behavioral Activation
Six face-to-face sessions (60 minutes each) of Behavioral Activation (BA) therapy
• Information and Support
Six face-to-face sessions (60 minutes each) of Supportive Therapy

Locations

Country	Name	City	State
United States	University of California San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelium-dependent Flow Mediated Dilation (FMD)	Flow-Mediated Dilation	Change from baseline to 2-year follow-up
Primary	Center for Epidemiologic Studies - Depression (CES-D) scale	Depressive Symptoms	Change from baseline to 2-year follow-up
Primary	Interleukin-6	Inflammation (IL-6)	Change from baseline to 2-year follow-up
Secondary	Baroreflex Sensitivity (BRS)	Arterial function (baroreceptors)	Change from baseline to 2-year follow-up
Secondary	Arterial Compliance (AC)	Arterial function	Change from baseline to 2-year follow-up
Secondary	Carotid Intima Media Thickness (IMT)	Vascular outcome	Change from baseline to 2-year follow-up
Secondary	D-dimer	Coagulation	Change from baseline to 2-year follow-up
Secondary	C-reactive Protein (CRP)	Inflammation	Change from baseline to 2-year follow-up
Secondary	Tumor Necrosis Factor (TNF)- alpha	Biomarker	Change from baseline to 2-year follow-up
Secondary	Plasminogen Activator Inhibitor (PAI)-1	Coagulation	Change from baseline to 2-year follow-up
Secondary	von Willebrand Factor (vWF)	Coagulation	Change from baseline to 2-year follow-up

External Links

•   Alzheimer's Caregiver Study