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Completed

NCT Number: NCT02317523

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Diego

La Jolla, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Activation

Behavioral

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

Information and Support

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 16, 2014
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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