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

NCT05131035 | Recruiting DMC

• 3 other identifiers: 21-0832, 23-0500R61MH123574R33MH123574
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychosis; Prodromal Schizophrenia; Prodromal Symptoms

Keywords

Clinical High Risk (CHR); Processing Speed; Social Functioning; Social Impairment; Social Skills; Adolescents; Cognitive Remediation

Outcome Measures

Primary Outcomes (1)

• Processing Speed domain score from the MATRICS Consensus Cognitive Battery (MCCB)

  Change in processing speed domain score and individual measures within the domain.

  Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)

Secondary Outcomes (2)

• Global Functioning: Social (GF:Social) scale (Phase 2/R33 only)

  Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)

• SIPS/SOPS: Positive Symptoms (Phase 2/R33 only)

  Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)

Study Arms (2)

Speeded Cognitive Training

EXPERIMENTAL

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.

Behavioral: SCORES (Specific COgnitive Remediation with Support)

Non-Speeded Cognitive Training

ACTIVE COMPARATOR

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.

Behavioral: SCORES (Specific COgnitive Remediation with Support)

Interventions

SCORES (Specific COgnitive Remediation with Support) 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; Speeded Cognitive Training

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Northwell Health- The Zucker Hillside Hospital

Glen Oaks, New York, 11042, United States

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Schizotypal Personality Disorder; Prodromal Symptoms; Social Adjustment; Social Skills

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Personality Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ricardo E Carrion, Ph.D.

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo E Carrion, Ph.D.

CONTACT

718-470-8788; rcarrion@northwell.edu

Danielle McLaughlin, M.A.

CONTACT

718-470-8375; dmclaugh@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 23, 2021
• Study Start: October 28, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: We plan to make all data collected available as a national resource to the broader scientific community for investigators wishing to pursue their own analyses. Consistent with the NIH policy regarding data sharing, we will share data no later than following acceptance for publication of the main findings from the final dataset, which is expected to occur at the end of year 5. We request that we maintain exclusive access to these data until the end of year 5 to ensure an adequate amount of time for the PIs to conduct analyses and prepare manuscripts for publication. All de-identified data resulting from this NIH-funded award will be submitted to the NIMH Data Archive (NDA) according to this timeline, along with appropriate supporting documentation to enable efficient use of the data by other researchers not involved in the study. Data derived from the proposed study will also be shared through presentation at research conferences and through publication in peer-reviewed journals.
• Access Criteria: Data will be shared with researchers upon request. Other researchers across the world can then request the pseudo-anonymized study data for other research from the NDA. Every researcher (and institutions to which they belong) who requests the pseudo-anonymized study data must promise to keep the data safe. Experts at the NIH will review each request carefully to reduce risks to participant privacy.

Locations

US (1)