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HARP-Project 1 Cognitive Training

HARP-Project 1 Cognitive Training

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03293823
Enrollment
30
Registered
2017-09-26
Start date
2017-10-04
Completion date
2018-12-14
Last updated
2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Social Isolation

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.

Interventions

BEHAVIORALVSOP training

a computerized cognitive training of attention and processing speed

BEHAVIORALMLA control

a computerized cognitive intervention of multiple mental leisure activities

Sponsors

University of Rochester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Participants will not be informed whether it is an intervention or control group; instead they will be informed they will receive a computerized cognitive intervention.

Intervention model description

6-week cognitive training group vs. an active control group

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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);

Design outcomes

Primary

MeasureTime frameDescription
cognitive capacitybaseline and 7 week post-trainingchange of executive function from baseline to 7 week post-training

Secondary

MeasureTime frameDescription
brain function 1 (BOLD fMRI)baseline and 7 week post-trainingbrain functional change in response to social scenario task from baseline to 7 week post-training
social well-beingbaseline and 7 week post-trainingchange of social well-being measured by HARP Social Connectedness and Well-Being Core Battery from baseline to 7 week
brain function 2 (BOLD fMRI)7 week post-training onlybrain functional adaptability to cyberball task

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026