Alzheimer's Caregiver Coping: Mental and Physical Health

NCT ID: NCT02317523

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-06-30

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.

Conditions

Alzheimer Disease; Alzheimer Dementia; Alzheimer's Disease; Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Behavioral Activation

Intervention Type: BEHAVIORAL

Six face-to-face sessions (60 minutes each) of Behavioral Activation (BA) therapy

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.

Group Type: ACTIVE_COMPARATOR

Information and Support

Intervention Type: BEHAVIORAL

Six face-to-face sessions (60 minutes each) of Supportive Therapy

Interventions

Behavioral Activation

Six face-to-face sessions (60 minutes each) of Behavioral Activation (BA) therapy

Intervention Type: BEHAVIORAL

Information and Support

Six face-to-face sessions (60 minutes each) of Supportive Therapy

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Brent Mausbach

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brent T Mausbach, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California San Diego

La Jolla, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30669980 (View on PubMed)

Other Identifiers

RF1AG015301

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BMausbach

Identifier Type: -

Identifier Source: org_study_id