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CompletedNCT03036423CTCUpdated Nov 7, 2022

Cognitive Training for Older Caregivers

An interventional study of Online video education and Computerized mental exercises in Life Stress, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 55 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-07.

Sponsored by University of Rochester · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
205
Allocation
Randomized
Ages
55 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • Life Stress

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In context

Stress, Psychological

783 studies on the registry are indexed under Stress, Psychological; 128 are open to participants now.

This study's enrollment of 205 is above the median of 85 across 632 interventional studies indexed under Stress, Psychological.

Browse Stress, Psychological studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
205 participants (actual)

Study arms

  • Active comparator
    Online video education

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

    Behavioral: Online video education

  • Active comparator
    Computerized mental exercises

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

    Behavioral: Computerized mental exercises

Interventions

  • BehavioralOnline video education
  • BehavioralComputerized mental exercises
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What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months after the intervention

  2. 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

    Time frame: 12 months after the intervention

  3. 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

    Time frame: 12 months after the intervention

  4. 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

    Time frame: 12 months after the intervention

  5. 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

    Time frame: 12 months after the intervention

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Study locations

1 site
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
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References and documents

Study documents

  • Informed consent form · Nov 9, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03036423
Lead sponsor
University of Rochester
Collaborators
National Institute on Aging (NIA)
Responsible party
Kathi Heffner (Associate Professor of Nursing and Psychiatry, University of Rochester) — Principal investigator
First posted
Jan 30, 2017
Start date
Sep 8, 2016
Primary completion
Jul 18, 2022
Completion
Jul 18, 2022
Last update
Nov 7, 2022

Study contacts

Kathi L Heffner, PhD
principal investigator · University of Rochester

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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