HARP-Project 1 Cognitive Training

NCT03293823 | Completed

• 1 other identifier: RSRB00067540
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

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.

Conditions

Aging; Social Isolation

Outcome Measures

Primary Outcomes (1)

• cognitive capacity

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

  baseline and 7 week post-training

Secondary Outcomes (3)

• brain function 1 (BOLD fMRI)

  baseline and 7 week post-training

• social well-being

  baseline and 7 week post-training

• brain function 2 (BOLD fMRI)

  7 week post-training only

Study Arms (2)

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.

Behavioral: VSOP training

active control

ACTIVE COMPARATOR

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

Behavioral: MLA control

Interventions

VSOP training BEHAVIORAL

a computerized cognitive training of attention and processing speed

vision-based speed of processing (VSOP) cognitive training

MLA control BEHAVIORAL

a computerized cognitive intervention of multiple mental leisure activities

active control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (4)

The Northfield

Fairport, New York, 14450, United States

Location

The Highlands

Pittsford, New York, 14534, United States

Location

River Edge Manor

Rochester, New York, 14620, United States

Location

St. Johns Meadows

Rochester, New York, 14620, United States

Location

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Anne Corriveau

  University of Rochester

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 6-week cognitive training group vs. an active control group

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 26, 2017
• Study Start: October 4, 2017
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)