Clinical trial NCT03293823: HARP-Project 1 Cognitive Training
Official title: HARP-Project 1 Cognitive Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Social Isolation
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 6-week cognitive training group vs. an active control group
Primary purpose: PREVENTION

Brief summary: Emerging evidence from social neuroscience suggests that prefrontal cortex (PFC), insular and anterior cingulate cortex (ACC) regulate social and emotional responses to acute threats to social connectedness among young adults. Deficient neural reserve or overused neural compensation resulting from neurodegeneration is commonly observed in these frontal regions in old age. This aging-related "neural depletion" may have implications for how older adults respond to social threats, potentially increasing maladaptive emotional and social behavioral responses, such as social anxiety and social avoidance, which contribute to social disconnectedness. The central hypothesis is that cognitive deficits and associated aging-related 'neural depletion' in the frontal regions will contribute to maladaptive social-emotional responses to a social stressor -- social exclusion. Ultimately, maladaptive responses to acute social stress, such as social anxiety and avoidance, can compromise social connectedness by increasing social strain and isolation. The investigators have recently developed a neuroplasticity-based cognitive training program, called vision-based speed of processing (VSOP) training, targeting multiple aspects of cognitive capacity (e.g., attention, working memory and inhibition) and incorporating the speed component to improve the efficiency of these cognitive processes. VSOP training also targets several neural networks seeded in ACC and insular (default mode network) or PFC (the frontal-striatal network and central executive network). These networks also overlap with neural substrates of emotion regulation. Notably, VSOP training appears to improve emotion regulation, as depressive symptoms were reduced in older adults following VSOP training. Finally, the autonomic nervous system (ANS), critical to stress adaptation, is regulated by these frontal regions. The objective of the proposed pilot study is to provide proof-of-concept for the hypothesis that improvements in older adults' cognitive capacity, frontal regions' neural efficiency, and ANS function via the VSOP training will be associated with more adaptive social-emotional response to social exclusion, which, in turn, should confer longer-term protection for older adults' sense of social connectedness. Randomized Controlled Trial Design: 30 older adults will be randomly assigned to engage in 6-week VSOP training, or to an active control group. Differential changes from baseline to post-training in cognitive capacity, neural efficiency, and ANS function, and sense of social connectedness, will be compared between VSOP control groups. A social exclusion paradigm ('cyberball' task) will be conducted post-training to evaluate VSOP training effects on social-emotional responses to social exclusion, including anxiety and motivation for social affiliation.


Eligibility criteria: Inclusion Criteria:

1. aged ≥ 60 years, community-dwelling, English-speaking, adequate vision and hearing for testing, capacity to give consent based on clinician assessment;
2. Telephone Interview for Cognitive Status (TICS) ≥ 31, Geriatric Depression Scale \< 7 (i.e., free of major depression that can interfere with neural efficiency for social-emotional regulation), EXAMINER composite score (a comprehensive executive function battery test package that is sensitive to frontal regions' neural efficiency change) \< .70 (i.e., reflecting decreased neural efficiency of frontal regions compared to cognitively health older adults in general);
3. moderate social relation difficulties: identified by World Health Organization Disability Assessment Scale (WHO-DAS), "Getting Along with Other People" domain, at least "moderate" difficulties endorsed; from HARP Database Project screening)

Exclusion Criteria:

1. a self-report clinical diagnosis of dementia or mild cognitive impairment;
2. MRI contraindications (e.g., pacemaker, metallic implant, claustrophobia);

Primary outcomes:
measure: cognitive capacity
timeFrame: baseline and 7 week post-training
Secondary outcomes:
measure: brain function 1 (BOLD fMRI)
timeFrame: baseline and 7 week post-training
measure: social well-being
timeFrame: baseline and 7 week post-training
measure: brain function 2 (BOLD fMRI)
timeFrame: 7 week post-training only
Other outcomes:
Locations:
city: Fairport
country: United States
facility: The Northfield
state: New York
city: Pittsford
country: United States
facility: The Highlands
state: New York
city: Rochester
country: United States
facility: River Edge Manor
state: New York
city: Rochester
country: United States
facility: St. Johns Meadows
state: New York
Study officials:
affiliation: University of Rochester
name: Anne Corriveau
role: STUDY_DIRECTOR
References: