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Cognitive Training for Older Caregivers (CTC)

Primary Purpose

Life Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online video education
Computerized mental exercises
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Life Stress

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • English-speaking (consent process and assessments will be conducted in English only)
  • Currently living with or in proximity to, and the primary caregiver for a loved one with dementia who lives in the community-for the purposes of this study, "loved one" refers to a family member such as a spouse, ex-spouse, significant other, sibling, in-law, parent, or other type of close established relationship (e.g., close friend) regarded as family; "primary caregivers" provide daily informal (non-paid) in-person care.
  • Currently experiencing moderate to high levels of perceived stress and caregiver burden. Caregivers will be screened for stress levels and caregiving burden using the 10-item Perceived Stress Scale (PSS 10) and the Modified Caregiver Strain Index (MCSI), respectively. Caregivers scoring above the population mean (approx.) on the PSS 10 (> 11), reporting at least moderate caregiver strain (score ≥ 5) on the MCSI will be eligible for participation.

Exclusion Criteria:

  • cognitive impairment or dementia (identified by the Montreal Cognitive Assessment (MoCA)). Cutoff scores on the MoCA will be 23 or lower except for subjects who identify as black or African American, in which case cutoffs will be based on scores from the sample population reported in Rossetti et al (2017); subjects scoring greater than one standard deviation below the published score, by respective age and education, will be excluded.
  • current major depression (current Major Depression diagnosis and/or Geriatric Depression Scale (GDS 15) score ≥ 10)
  • no recent (within 2 months) major surgery
  • History of events that cause neurological injury (e.g., stroke, transient ischemic attack, traumatic brain injury or head injury with loss of consciousness)
  • Serious psychiatric or alcohol/substance use disorders, including current alcohol dependence, current non-alcohol psychoactive substance use dependence, psychotic disorders or features (current and lifetime), bipolar disorder (determined from Mini International Neuropsychiatric Exam (MINI) modules)
  • Autoimmune disorder (e.g., Crohn's disease, lupus, rheumatoid arthritis)
  • Active neoplastic disease or receiving immunosuppressive therapy for cancer (or < 6 months post-chemo or radiation) or other diseases (< 3 months prior to enrollment)
  • No significant immunodeficiency disorder (e.g., alymphocytosis, hepatitis B or C, HIV)
  • Serious cardiovascular disease (e.g., congestive heart failure, pacemaker) or myocardial infarction within past 6 months
  • Physical condition precluding required activities as part of the computerized cognitive training (e.g., inability to use a computer mouse; inadequate visual acuity)

Sites / Locations

  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Online video education

Computerized mental exercises

Arm Description

Participants will have computer access to a library of videos, including various lectures and demonstrations of interest, from which to select and view.

Participants will use a computer to do a variety of activities which are customizable to their own abilities and progress.

Outcomes

Primary Outcome Measures

Useful Field of View test performance at 12 months after the intervention
Useful Field of View computerized test of speed of processing and attention; lower score (in milliseconds) reflects better performance
Resting high frequency heart rate variability (HF-HRV) at 12 months after the intervention
HF-HRV is derived by spectral analysis of the electrocardiograph (ECG) waveform and is a measure of parasympathetic control of the heart; Higher resting HF-HRV (in Hz) reflects greater parasympathetic regulation of the heart
Emotion regulation at 12 months after the intervention
Measured as change in negative affect (from responses to the self-assessment manikin on a 9-point scale) from before to after a mental challenge; less increase in negative affect score suggests better emotion regulation
Emotional well-being at 12 months after the intervention
The primary index of emotional well-being will be depressive symptoms (Center for Epidemiology Studies Depression scale); a lower score on this measure indicates less depressive symptoms
Immune aging
Identified from blood samples; lower levels of inflammation (measured by enzyme-linked immunosorbent assay (ELISA) assay) and T-lymphocyte profiles that reflect larger ratios of naïve T-cells relative to mature T-cells (measured from flow cytometry) will index less aging of the immune system

Secondary Outcome Measures

Full Information

First Posted
November 10, 2016
Last Updated
November 4, 2022
Sponsor
University of Rochester
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03036423
Brief Title
Cognitive Training for Older Caregivers
Acronym
CTC
Official Title
Cognitive Training to Protect Immune Systems of Older Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 8, 2016 (Actual)
Primary Completion Date
July 18, 2022 (Actual)
Study Completion Date
July 18, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to test whether certain brain training activities can promote cognitive, emotional, and physical health in caregivers of a loved one with dementia. Numerous studies show that family dementia caregiving can be stressful, and can increase mental and physical health risks. This study aims to understand how to reduce those risks.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Online video education
Arm Type
Active Comparator
Arm Description
Participants will have computer access to a library of videos, including various lectures and demonstrations of interest, from which to select and view.
Arm Title
Computerized mental exercises
Arm Type
Active Comparator
Arm Description
Participants will use a computer to do a variety of activities which are customizable to their own abilities and progress.
Intervention Type
Behavioral
Intervention Name(s)
Online video education
Intervention Type
Behavioral
Intervention Name(s)
Computerized mental exercises
Primary Outcome Measure Information:
Title
Useful Field of View test performance at 12 months after the intervention
Description
Useful Field of View computerized test of speed of processing and attention; lower score (in milliseconds) reflects better performance
Time Frame
12 months after the intervention
Title
Resting high frequency heart rate variability (HF-HRV) at 12 months after the intervention
Description
HF-HRV is derived by spectral analysis of the electrocardiograph (ECG) waveform and is a measure of parasympathetic control of the heart; Higher resting HF-HRV (in Hz) reflects greater parasympathetic regulation of the heart
Time Frame
12 months after the intervention
Title
Emotion regulation at 12 months after the intervention
Description
Measured as change in negative affect (from responses to the self-assessment manikin on a 9-point scale) from before to after a mental challenge; less increase in negative affect score suggests better emotion regulation
Time Frame
12 months after the intervention
Title
Emotional well-being at 12 months after the intervention
Description
The primary index of emotional well-being will be depressive symptoms (Center for Epidemiology Studies Depression scale); a lower score on this measure indicates less depressive symptoms
Time Frame
12 months after the intervention
Title
Immune aging
Description
Identified from blood samples; lower levels of inflammation (measured by enzyme-linked immunosorbent assay (ELISA) assay) and T-lymphocyte profiles that reflect larger ratios of naïve T-cells relative to mature T-cells (measured from flow cytometry) will index less aging of the immune system
Time Frame
12 months after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English-speaking (consent process and assessments will be conducted in English only) Currently living with or in proximity to, and the primary caregiver for a loved one with dementia who lives in the community-for the purposes of this study, "loved one" refers to a family member such as a spouse, ex-spouse, significant other, sibling, in-law, parent, or other type of close established relationship (e.g., close friend) regarded as family; "primary caregivers" provide daily informal (non-paid) in-person care. Currently experiencing moderate to high levels of perceived stress and caregiver burden. Caregivers will be screened for stress levels and caregiving burden using the 10-item Perceived Stress Scale (PSS 10) and the Modified Caregiver Strain Index (MCSI), respectively. Caregivers scoring above the population mean (approx.) on the PSS 10 (> 11), reporting at least moderate caregiver strain (score ≥ 5) on the MCSI will be eligible for participation. Exclusion Criteria: cognitive impairment or dementia (identified by the Montreal Cognitive Assessment (MoCA)). Cutoff scores on the MoCA will be 23 or lower except for subjects who identify as black or African American, in which case cutoffs will be based on scores from the sample population reported in Rossetti et al (2017); subjects scoring greater than one standard deviation below the published score, by respective age and education, will be excluded. current major depression (current Major Depression diagnosis and/or Geriatric Depression Scale (GDS 15) score ≥ 10) no recent (within 2 months) major surgery History of events that cause neurological injury (e.g., stroke, transient ischemic attack, traumatic brain injury or head injury with loss of consciousness) Serious psychiatric or alcohol/substance use disorders, including current alcohol dependence, current non-alcohol psychoactive substance use dependence, psychotic disorders or features (current and lifetime), bipolar disorder (determined from Mini International Neuropsychiatric Exam (MINI) modules) Autoimmune disorder (e.g., Crohn's disease, lupus, rheumatoid arthritis) Active neoplastic disease or receiving immunosuppressive therapy for cancer (or < 6 months post-chemo or radiation) or other diseases (< 3 months prior to enrollment) No significant immunodeficiency disorder (e.g., alymphocytosis, hepatitis B or C, HIV) Serious cardiovascular disease (e.g., congestive heart failure, pacemaker) or myocardial infarction within past 6 months Physical condition precluding required activities as part of the computerized cognitive training (e.g., inability to use a computer mouse; inadequate visual acuity)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathi L Heffner, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Cognitive Training for Older Caregivers

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