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Completed

NCT Number: NCT03036423

Cognitive Training for Older Caregivers

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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Key information

Conditions

Life Stress Behavior Behavioral Symptoms Stress, Psychological

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Online video education

Behavioral

Computerized mental exercises

Behavioral

Primary outcomes

  1. Useful Field of View test performance at 12 months after the intervention

    Time frame: 12 months after the intervention

    Useful Field of View computerized test of speed of processing and attention; lower score (in milliseconds) reflects better performance

  2. Resting high frequency heart rate variability (HF-HRV) at 12 months after the intervention

    Time frame: 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

  3. Emotion regulation at 12 months after the intervention

    Time frame: 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

  4. Emotional well-being at 12 months after the intervention

    Time frame: 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

  5. Immune aging

    Time frame: 12 months after the intervention

    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

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Cognitive Training to Protect Immune Systems of Older Caregivers

Acronym: CTC

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jan 30, 2017
Registry last updated
Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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