Targeting Processing Speed Deficits to Improve Social Functioning and Lower Psychosis Risk

NCT ID: NCT05131035

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-28

Study Completion Date

2026-05-31

Brief Summary

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This 10 week intervention, Specific Cognitive Remediation with Surround (or SCORES), is designed to target processing speed, a cognitive domain related directly to social functioning, which in turn, represents a vulnerability factor for psychosis. This remotely-delivered intervention combining targeted cognitive training exercises and group support was developed to directly impact processing speed, and at the same time, boost motivation and engagement in adolescents at risk for schizophrenia and other psychotic disorders.

Detailed Description

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This study evaluates the effectiveness of a cognitive remediation (CR) program plus group coaching and support designed to improve processing speed and, in turn, social functioning and attenuated positive symptoms in individual considered Clinical High Risk for psychosis. The SCORES (Specific COgnitive REmediation with Support) intervention is a novel Cognitive Remediation program combined with group coaching, performance-based rewards, game-like tasks, and educational elements to increase engagement and retention. The study is funded by a R61/R33 award. In the R61 phase, all participants were asked to complete 40 hours of Cognitive Remediation or brain training (4 hours per week/10 weeks) with a mid-point assessment (at 5 weeks) to determine the training dose needed to impact processing speed as measured by the Matrics Cognitive Consensus Battery. The current R33 (Phase 2) will look to replicate the results of the R61 and assess the specificity of the targeted intervention with the addition of a non-speeded cognitive training group..

Conditions

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Psychosis Prodromal Schizophrenia Prodromal Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The R33 study design will utilize a randomized intervention model. All participants will participate in cognitive training with small group support.One group will complete speeded cognitive training tasks and the other group will complete non-speeded cognitive training tasks.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Speeded Cognitive Training

Participants in this condition will complete 40 hours of Cognitive Remediation with a mid-point assessment (20 hours/5 weeks) to determine the impact of speeded cognitive training tasks on cognition and social function.

Group Type EXPERIMENTAL

SCORES (Specific COgnitive Remediation with Support)

Intervention Type BEHAVIORAL

This study evaluates the effectiveness of a 10-week cognitive remediation program plus group coaching and therapy to improve processing speed and, in turn, social functioning and attenuated positive symptoms in CHR subjects. The SCORES (Specific COgnitive Remediation with Support) intervention is a novel CR program combined with group coaching, performance-based rewards, game-like tasks, and therapy elements to increase engagement and retention.

In the 2 year, R61 phase, all participants will complete 40 hours of CR (4 hrs per week) with a mid-point assessment (20 hours of CR at 5 weeks) to determine the impact of CR on processing speed as measured by the MCCB.

The second phase of the study (R33) will compare the 40 hours of speeded brain training to 40 hours of non-speeded brain training. This three year study will allow for a replication and assessment of specificity of the targeted intervention.

Non-Speeded Cognitive Training

Participants in this condition will complete 40 hours of Cognitive Remediation with a mid-point assessment (20 hours/5 weeks) to determine the impact of non-speeded cognitive training tasks on cognition and social function.

Group Type ACTIVE_COMPARATOR

SCORES (Specific COgnitive Remediation with Support)

Intervention Type BEHAVIORAL

This study evaluates the effectiveness of a 10-week cognitive remediation program plus group coaching and therapy to improve processing speed and, in turn, social functioning and attenuated positive symptoms in CHR subjects. The SCORES (Specific COgnitive Remediation with Support) intervention is a novel CR program combined with group coaching, performance-based rewards, game-like tasks, and therapy elements to increase engagement and retention.

In the 2 year, R61 phase, all participants will complete 40 hours of CR (4 hrs per week) with a mid-point assessment (20 hours of CR at 5 weeks) to determine the impact of CR on processing speed as measured by the MCCB.

The second phase of the study (R33) will compare the 40 hours of speeded brain training to 40 hours of non-speeded brain training. This three year study will allow for a replication and assessment of specificity of the targeted intervention.

Interventions

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SCORES (Specific COgnitive Remediation with Support)

This study evaluates the effectiveness of a 10-week cognitive remediation program plus group coaching and therapy to improve processing speed and, in turn, social functioning and attenuated positive symptoms in CHR subjects. The SCORES (Specific COgnitive Remediation with Support) intervention is a novel CR program combined with group coaching, performance-based rewards, game-like tasks, and therapy elements to increase engagement and retention.

In the 2 year, R61 phase, all participants will complete 40 hours of CR (4 hrs per week) with a mid-point assessment (20 hours of CR at 5 weeks) to determine the impact of CR on processing speed as measured by the MCCB.

The second phase of the study (R33) will compare the 40 hours of speeded brain training to 40 hours of non-speeded brain training. This three year study will allow for a replication and assessment of specificity of the targeted intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Meet Clinical High Risk (CHR) criteria on the Structured Interview for Psychosis Risk Syndromes, defined by the presence of at least one attenuated positive symptom at a moderate to severe level
* A score representing 0.5 SD below the mean on Animal Naming, Trails A or BACS: Symbol Coding from the MATRICS Consensus Cognitive Battery (MCCB).

Exclusion Criteria

* Any DSM 5 Schizophrenia-Spectrum diagnosis
* Non-English speaking
* Past or current history of a clinically significant central nervous system disorder (e.g., seizure disorder)
* Estimated IQ\<70
* Significant head injury
* Significant substance abuse
* Significant visual or auditory impairment.
Minimum Eligible Age

14 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ricardo E Carrion, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

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Northwell Health- The Zucker Hillside Hospital

Glen Oaks, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ricardo E Carrion, Ph.D.

Role: CONTACT

718-470-8788

Danielle McLaughlin, M.A.

Role: CONTACT

718-470-8375

Facility Contacts

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Andrea M Auther, Ph.D.

Role: primary

718-470-8147

Danielle McLaughlin, M.A.

Role: backup

718-470-8375

Other Identifiers

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R61MH123574

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R33MH123574

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-0832, 23-0500

Identifier Type: -

Identifier Source: org_study_id

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