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Alzheimer's Caregiver Coping: Mental and Physical Health

Primary Purpose

Alzheimer Disease, Alzheimer Dementia, Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation
Information and Support
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Dementia, Caregiver, Cardiovascular Disease, Stress, Depression, Anxiety, Heart Disease, Carer, Care Giver, Caregiving, Psychotherapy, Therapy, Behavioral Activation, Education, Intervention, CBT, Cognitive-Behavior Therapy

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavioral Activation

Information and Support

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Endothelium-dependent Flow Mediated Dilation (FMD)
Flow-Mediated Dilation
Center for Epidemiologic Studies - Depression (CES-D) scale
Depressive Symptoms
Interleukin-6
Inflammation (IL-6)

Secondary Outcome Measures

Baroreflex Sensitivity (BRS)
Arterial function (baroreceptors)
Arterial Compliance (AC)
Arterial function
Carotid Intima Media Thickness (IMT)
Vascular outcome
D-dimer
Coagulation
C-reactive Protein (CRP)
Inflammation
Tumor Necrosis Factor (TNF)- alpha
Biomarker
Plasminogen Activator Inhibitor (PAI)-1
Coagulation
von Willebrand Factor (vWF)
Coagulation

Full Information

First Posted
December 11, 2014
Last Updated
September 24, 2019
Sponsor
University of California, San Diego
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT02317523
Brief Title
Alzheimer's Caregiver Coping: Mental and Physical Health
Official Title
Alzheimer's Caregiver Coping: Mental and Physical Health
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Activation
Arm Type
Experimental
Arm Description
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.
Arm Title
Information and Support
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation
Intervention Description
Six face-to-face sessions (60 minutes each) of Behavioral Activation (BA) therapy
Intervention Type
Behavioral
Intervention Name(s)
Information and Support
Intervention Description
Six face-to-face sessions (60 minutes each) of Supportive Therapy
Primary Outcome Measure Information:
Title
Endothelium-dependent Flow Mediated Dilation (FMD)
Description
Flow-Mediated Dilation
Time Frame
Change from baseline to 2-year follow-up
Title
Center for Epidemiologic Studies - Depression (CES-D) scale
Description
Depressive Symptoms
Time Frame
Change from baseline to 2-year follow-up
Title
Interleukin-6
Description
Inflammation (IL-6)
Time Frame
Change from baseline to 2-year follow-up
Secondary Outcome Measure Information:
Title
Baroreflex Sensitivity (BRS)
Description
Arterial function (baroreceptors)
Time Frame
Change from baseline to 2-year follow-up
Title
Arterial Compliance (AC)
Description
Arterial function
Time Frame
Change from baseline to 2-year follow-up
Title
Carotid Intima Media Thickness (IMT)
Description
Vascular outcome
Time Frame
Change from baseline to 2-year follow-up
Title
D-dimer
Description
Coagulation
Time Frame
Change from baseline to 2-year follow-up
Title
C-reactive Protein (CRP)
Description
Inflammation
Time Frame
Change from baseline to 2-year follow-up
Title
Tumor Necrosis Factor (TNF)- alpha
Description
Biomarker
Time Frame
Change from baseline to 2-year follow-up
Title
Plasminogen Activator Inhibitor (PAI)-1
Description
Coagulation
Time Frame
Change from baseline to 2-year follow-up
Title
von Willebrand Factor (vWF)
Description
Coagulation
Time Frame
Change from baseline to 2-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent T Mausbach, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30669980
Citation
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.
Results Reference
derived

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Alzheimer's Caregiver Coping: Mental and Physical Health

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