Alzheimer's Caregiver Coping: Mental and Physical Health

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease; Alzheimer's Disease; Alzheimer Dementia
• Intervention / Treatment: Behavioral: Behavioral Activation; Behavioral: Information and Support

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 Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University of California San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Behavioral Activation; Six face-to-face sessions (60 minutes each) of Behavioral Activation (BA) therapy
Active Comparator: 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.	Behavioral: Information and Support; Six face-to-face sessions (60 minutes each) of Supportive Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelium-dependent Flow Mediated Dilation (FMD)	Flow-Mediated Dilation	Change from baseline to 2-year follow-up
Center for Epidemiologic Studies - Depression (CES-D) scale	Depressive Symptoms	Change from baseline to 2-year follow-up
Interleukin-6	Inflammation (IL-6)	Change from baseline to 2-year follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Brent T Mausbach, PhD, University of California, San Diego

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: December 11, 2014
• First Submitted That Met QC Criteria: December 15, 2014
• First Posted (Estimate): December 16, 2014

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Depression; Behavioral Activation; Anxiety; Stress; Cardiovascular Disease; Dementia; Caregiver; Intervention; Therapy; CBT; Education; Heart Disease; Psychotherapy; Caregiving; Care Giver; Cognitive-Behavior Therapy; Carer
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: BMausbach; RF1AG015301 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED