An interventional study of VSOP training and MLA control in Aging and Social Isolation, sponsored by University of Rochester. Completed at 4 sites in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-05.
Sponsored by University of Rochester · Not applicable, Interventional, and Prevention
Among 97 studies in Social Isolation with a site in United States — 26 open to participants now, 29 under way, none of them phase 3. Social Isolation · United States.
Among the 97 studies in Social Isolation with a site in United States, this one is the 75th largest by enrollment of the 92 interventional ones that give a count, is one of 7 that started in 2017, is one of 89 with no phase, and was the 12th registered.
236 studies on the registry are indexed under Social Isolation; 61 are open to participants now.
This study's enrollment of 30 is below the median of 80 across 198 interventional studies indexed under Social Isolation.
Browse Social Isolation studies →26 of the 97 studies in Social Isolation with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 34 Social Isolation studies recruiting now, 22 (65%) set no upper age limit and 6 (18%) stop at 75 or younger; 4 take children under 18; 18 take healthy volunteers.
This study: 60 Years and older · all sexes · healthy volunteers too.
The full table on the hub →97 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 7 started in 2017.
Median enrollment 79 across the 92 interventional studies, 650 across the 5 observational. Of the 65 that completed or were terminated, 22 (34%) have results posted.
1 of 97 have an industry lead sponsor. The 10 most frequent:
University of Rochester is the lead sponsor of 729 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
University of Rochester has 9 studies filed under Social Isolation — fewer than ten, so there is no comparison to draw.
8 of the studies in Social Isolation with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06721559University of MichiganEmpower@Home: Community Implementation for Older Adults With Ambulatory Disabilities | 2026-12 |
| NCT04391816National Institute on Alcohol Abuse and Alcoholism (NIAAA)COVID-19 Pandemic Impact on Alcohol (PIA) - A Natural History Study | 2026-12-31 |
| NCT06817993University of PittsburghTeen Brain Online II: Understanding How Social Media Affects the Teen Brain | 2027-03-30 |
| NCT07863583Johns Hopkins UniversitySocial Connection Collective for Older Adults in Subsidized Housing | 2027-04 |
| NCT07123298Johns Hopkins UniversityCAPABLE Care + Connect | 2027-05 |
Among the 97 studies in Social Isolation with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
use the INSIGHT online program (Posit Science), which includes five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
Behavioral: VSOP training
The standardized computerized leisure activities program - MLA, including crossword puzzle, Sudoku, etc. will be used
Behavioral: MLA control
a computerized cognitive training of attention and processing speed
a computerized cognitive intervention of multiple mental leisure activities
cognitive capacity
change of executive function from baseline to 7 week post-training
Time frame: baseline and 7 week post-training
brain function 1 (BOLD fMRI)
brain functional change in response to social scenario task from baseline to 7 week post-training
Time frame: baseline and 7 week post-training
social well-being
change of social well-being measured by HARP Social Connectedness and Well-Being Core Battery from baseline to 7 week
Time frame: baseline and 7 week post-training
brain function 2 (BOLD fMRI)
brain functional adaptability to cyberball task
Time frame: 7 week post-training only
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Dec 2018, 14 months.
Of 155 non-industry interventional studies with no phase under Social Isolation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 14 months is below that.
Counting every sponsor, half of 156 studies reached it within 18 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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