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Cognitive Training for Older Caregivers (CTC)

University of Rochester logo

University of Rochester

Status

Completed

Conditions

Life Stress

Treatments

Behavioral: Computerized mental exercises
Behavioral: Online video education

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03036423
STUDY0001991
R01AG049764 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

205 patients

Sex

All

Ages

55 to 85 years old

Volunteers

Accepts 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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

205 participants in 2 patient groups

Online video education
Active Comparator group
Description:
Participants will have computer access to a library of videos, including various lectures and demonstrations of interest, from which to select and view.
Treatment:
Behavioral: Online video education
Computerized mental exercises
Active Comparator group
Description:
Participants will use a computer to do a variety of activities which are customizable to their own abilities and progress.
Treatment:
Behavioral: Computerized mental exercises

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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