Alzheimer's Caregiver Coping: Mental and Physical Health

NCT02317523 | Completed

• 2 other identifiers: BMausbachRF1AG015301
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Baroreflex Sensitivity (BRS)

  Change from baseline to 2-year follow-up

• Arterial Compliance (AC)

  Change from baseline to 2-year follow-up

• Carotid Intima Media Thickness (IMT)

  Change from baseline to 2-year follow-up

• D-dimer

  Change from baseline to 2-year follow-up

• C-reactive Protein (CRP)

  Change from baseline to 2-year follow-up

Study Arms (2)

Behavioral Activation

EXPERIMENTAL

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

Information and Support

ACTIVE COMPARATOR

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

Interventions

Behavioral Activation BEHAVIORAL

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

Behavioral Activation

Information and Support BEHAVIORAL

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

Information and Support

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 55 years or older.
• Providing in-home care to a spouse with dementia.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

Location

Related Publications (1)

• 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.

  PMID: 30669980 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cardiovascular Diseases; Depression; Anxiety Disorders; Heart Diseases

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Brent T Mausbach, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 16, 2014
• Study Start: September 1, 2014
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

US (1)