AgingNCT03293823
HARP-Project 1 Cognitive Training
A study testing VSOP training in people with Aging and Social Isolation, run by University of Rochester at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Social Isolation
- What is being tested?
- VSOP training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Oct 2017to 14 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged ≥ 60 years, community-dwelling, English-speaking, adequate vision and hearing for testing, capacity to give consent based on clinician assessment;
- 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);
- 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)
Who cannot join
- a self-report clinical diagnosis of dementia or mild cognitive impairment;
- MRI contraindications (e.g., pacemaker, metallic implant, claustrophobia);
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Northfield
Fairport, New York, 14450
The Highlands
Pittsford, New York, 14534
River Edge Manor
Rochester, New York, 14620
St. Johns Meadows
Rochester, New York, 14620
About this study
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.
- Conditions
- Aging, Social Isolation
- Being tested
- VSOP training, MLA control
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSOP trainingBehavioural
a computerized cognitive training of attention and processing speed
MLA controlBehavioural
a computerized cognitive intervention of multiple mental leisure activities
| Study group | Role | What they receive |
|---|---|---|
| vision-based speed of processing (VSOP) cognitive training | Experimental | 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. Receives: Behavioral: VSOP training |
| active control | Active comparator | The standardized computerized leisure activities program - MLA, including crossword puzzle, Sudoku, etc. will be used Receives: Behavioral: MLA control |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive capacity
change of executive function from baseline to 7 week post-training
Measured: baseline and 7 week post-training
Secondary outcomes (3)
brain function 1 (BOLD fMRI)
brain functional change in response to social scenario task from baseline to 7 week post-training
Measured: 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
Measured: baseline and 7 week post-training
brain function 2 (BOLD fMRI)
brain functional adaptability to cyberball task
Measured: 7 week post-training only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start4 Oct 2017
- Primary completion14 Dec 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 6-week cognitive training group vs. an active control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vankee Lin, University of Rochester
- Investigators
- Anne Corriveau, Study director, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293823
- Sponsor's protocol ID
- RSRB00067540
- Status last verified
- Jul 2019
- First submitted
- 18 Sep 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HARP-Project 1 Cognitive Training
- ClinicalTrials.gov ID
- NCT03293823
- Acronym / sponsor ID
- RSRB00067540
- Conditions
- Aging, Social Isolation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 6-week cognitive training group vs. an active control group
| Arm | Type | Receives |
|---|---|---|
| vision-based speed of processing (VSOP) cognitive training | Experimental | Behavioral: VSOP traininguse 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. |
| active control | Active comparator | Behavioral: MLA controlThe standardized computerized leisure activities program - MLA, including crossword puzzle, Sudoku, etc. will be used |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged ≥ 60 years, community-dwelling, English-speaking, adequate vision and hearing for testing, capacity to give consent based on clinician assessment;
- 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);
- 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)
Key exclusion criteria (2 listed)
- a self-report clinical diagnosis of dementia or mild cognitive impairment;
- MRI contraindications (e.g., pacemaker, metallic implant, claustrophobia);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VSOP traininga computerized cognitive training of attention and processing speed | Behavioural | vision-based speed of processing (VSOP) cognitive training |
| MLA controla computerized cognitive intervention of multiple mental leisure activities | Behavioural | active control |
Primary outcome
cognitive capacity
Time frame: baseline and 7 week post-training
change of executive function from baseline to 7 week post-training
3 secondary outcomes
brain function 1 (BOLD fMRI)
Time frame: baseline and 7 week post-training
social well-being
Time frame: baseline and 7 week post-training
brain function 2 (BOLD fMRI)
Time frame: 7 week post-training only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Corriveau study director
University of Rochester
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VSOP training in people with Aging and Social Isolation, run by University of Rochester at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive capacity (time frame: baseline and 7 week post-training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.