NCT03036423

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2022

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

5.9 years

First QC Date

November 10, 2016

Last Update Submit

November 4, 2022

Conditions

Life Stress

Outcome Measures

Primary Outcomes (5)

  • 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

    12 months after the intervention

  • 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

    12 months after the intervention

  • 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

    12 months after the intervention

  • 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

    12 months after the intervention

  • 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

    12 months after the intervention

Study Arms (2)

Online video education

ACTIVE COMPARATOR

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

Computerized mental exercises

ACTIVE COMPARATOR

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

Online video educationBEHAVIORAL
Online video education
Computerized mental exercisesBEHAVIORAL
Computerized mental exercises

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • Heffner KL, Crean HF, Gallegos AM, Quinones-Cordero MM, Weber MT, Sorensen S, Lin RSY, Podgorski CA, Lin FV. Speed of Processing Training for Stress Adaptation in Caregivers of a Family Member With Dementia: A Randomized Controlled Trial. Innov Aging. 2025 Mar 22;9(5):igaf033. doi: 10.1093/geroni/igaf033. eCollection 2025.

    PMID: 40454426DERIVED

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Kathi L Heffner, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Nursing and Psychiatry

Study Record Dates

First Submitted

November 10, 2016

First Posted

January 30, 2017

Study Start

September 8, 2016

Primary Completion

July 18, 2022

Study Completion

July 18, 2022

Last Updated

November 7, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)