Clinical trial NCT03036423: Cognitive Training for Older Caregivers
Official title: Cognitive Training to Protect Immune Systems of Older Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Life Stress
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-01-30
Enrollment: 205
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Useful Field of View test performance at 12 months after the intervention
timeFrame: 12 months after the intervention
measure: Resting high frequency heart rate variability (HF-HRV) at 12 months after the intervention
timeFrame: 12 months after the intervention
measure: Emotion regulation at 12 months after the intervention
timeFrame: 12 months after the intervention
measure: Emotional well-being at 12 months after the intervention
timeFrame: 12 months after the intervention
measure: Immune aging
timeFrame: 12 months after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Kathi L Heffner, PhD
role: PRINCIPAL_INVESTIGATOR
References: