ClinicalTrials.gg
CompletedNCT03293823Updated Jul 5, 2019

HARP-Project 1 Cognitive Training

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

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

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.

Enrollment
75th of 92
30 · median 79
Started
2017
with 6 others
No phase
89 of 97
24 open now
Registered
12th of 97
by date
Lead sponsor
9 of 97
University of Rochester

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.

Social Isolation

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 →

Open to participants now

26 of the 97 studies in Social Isolation with a site in United States are open now.

All 26 open studies →

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 →

Who these studies take

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 →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 97 studies in Social Isolation with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Aging
  • Social Isolation

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04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

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

Exclusion Criteria:

  1. a self-report clinical diagnosis of dementia or mild cognitive impairment;
  2. MRI (e.g., pacemaker, metallic implant, claustrophobia);
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    vision-based speed of processing (VSOP) cognitive training

    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

  • Active comparator
    active control

    The standardized computerized leisure activities program - MLA, including crossword puzzle, Sudoku, etc. will be used

    Behavioral: MLA control

Interventions

  • BehavioralVSOP training

    a computerized cognitive training of attention and processing speed

  • BehavioralMLA control

    a computerized cognitive intervention of multiple mental leisure activities

06

What researchers measure

Primary outcomes

  1. cognitive capacity

    change of executive function from baseline to 7 week post-training

    Time frame: baseline and 7 week post-training

Secondary outcomes

  1. 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

  2. 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

  3. brain function 2 (BOLD fMRI)

    brain functional adaptability to cyberball task

    Time frame: 7 week post-training only

07

Study locations

4 sites
  • The Northfield
    Fairport, New York 14450, United States
  • The Highlands
    Pittsford, New York 14534, United States
  • River Edge Manor
    Rochester, New York 14620, United States
  • St. Johns Meadows
    Rochester, New York 14620, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Sep 18, 2017
First posted
Sep 26, 2017
StartActual
Oct 4, 2017
Primary completionActual
Dec 14, 2018
CompletionActual
Dec 14, 2018
Last update
Jul 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03293823
Responsible party
Vankee Lin (Assistant Professor, University of Rochester) — Principal investigator
First posted
Sep 26, 2017
Start date
Oct 4, 2017
Primary completion
Dec 14, 2018
Completion
Dec 14, 2018
Last update
Jul 5, 2019

Study contacts

Anne Corriveau
study director · University of Rochester

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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