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Alzheimer's Caregiver Coping: Mental and Physical Health

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ClinicalTrials.gov Identifier: NCT02317523
Recruitment Status : Recruiting
First Posted : December 16, 2014
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Brent Mausbach, 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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Alzheimer Dementia Alzheimer's Disease Dementia Behavioral: Behavioral Activation Behavioral: Information and Support Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alzheimer's Caregiver Coping: Mental and Physical Health
Study Start Date : September 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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




Primary Outcome Measures :
  1. Endothelium-dependent Flow Mediated Dilation (FMD) [ Time Frame: Change from baseline to 2-year follow-up ]
    Flow-Mediated Dilation

  2. Center for Epidemiologic Studies - Depression (CES-D) scale [ Time Frame: Change from baseline to 2-year follow-up ]
    Depressive Symptoms

  3. Interleukin-6 [ Time Frame: Change from baseline to 2-year follow-up ]
    Inflammation (IL-6)


Secondary Outcome Measures :
  1. Baroreflex Sensitivity (BRS) [ Time Frame: Change from baseline to 2-year follow-up ]
    Arterial function (baroreceptors)

  2. Arterial Compliance (AC) [ Time Frame: Change from baseline to 2-year follow-up ]
    Arterial function

  3. Carotid Intima Media Thickness (IMT) [ Time Frame: Change from baseline to 2-year follow-up ]
    Vascular outcome

  4. D-dimer [ Time Frame: Change from baseline to 2-year follow-up ]
    Coagulation

  5. C-reactive Protein (CRP) [ Time Frame: Change from baseline to 2-year follow-up ]
    Inflammation

  6. Tumor Necrosis Factor (TNF)- alpha [ Time Frame: Change from baseline to 2-year follow-up ]
    Biomarker

  7. Plasminogen Activator Inhibitor (PAI)-1 [ Time Frame: Change from baseline to 2-year follow-up ]
    Coagulation

  8. von Willebrand Factor (vWF) [ Time Frame: Change from baseline to 2-year follow-up ]
    Coagulation



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317523


Contacts
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Contact: Brent T Mausbach, PhD 858-822-7529
Contact: Jean-Loup Bitterlin 858-534-9479

Locations
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United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Brent Mausbach, PhD         
Principal Investigator: Brent Mausbach, PhD         
Sponsors and Collaborators
University of California, San Diego
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Brent T Mausbach, PhD University of California, San Diego

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brent Mausbach, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02317523     History of Changes
Other Study ID Numbers: BMausbach
RF1AG015301 ( U.S. NIH Grant/Contract )
First Posted: December 16, 2014    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Brent Mausbach, University of California, San Diego:
Dementia
Caregiver
Cardiovascular Disease
Stress
Depression
Anxiety
Heart Disease
Carer
Care Giver
Caregiving
Psychotherapy
Therapy
Behavioral Activation
Education
Intervention
CBT
Cognitive-Behavior Therapy

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders