Cognitive Training for Older Caregivers

NCT ID: NCT03036423

Last Updated: 2022-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-08
• Study Completion Date: 2022-07-18

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.

Conditions

Life Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Online video education

Intervention Type: BEHAVIORAL

Computerized mental exercises

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

Group Type: ACTIVE_COMPARATOR

Computerized mental exercises

Intervention Type: BEHAVIORAL

Interventions

Online video education

Intervention Type: BEHAVIORAL

Computerized mental exercises

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Kathi Heffner

Associate Professor of Nursing and Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathi L Heffner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40454426 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01AG049764

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY0001991

Identifier Type: -

Identifier Source: org_study_id