Cognitive Training for Older Caregivers

Life Stress Clinical Trial

— CTC  

Official title:

Cognitive Training to Protect Immune Systems of Older Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036423
• Other study ID #: STUDY0001991
• Secondary ID: R01AG049764
• Status: Completed
• Phase: N/A
• Start date: September 8, 2016
• Est. completion date: July 18, 2022

Study information

• Verified date: November 2022
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: July 18, 2022
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Life Stress
• Stress, Psychological

Intervention

Behavioral:
• Online video education

• Computerized mental exercises

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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