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

Not Applicable

Recruiting

• Conditions: Prodromal Schizophrenia; Prodromal Symptoms; Psychosis
• Interventions: Behavioral: SCORES (Specific COgnitive Remediation with Support)

• Registration Number: NCT05131035
• Lead Sponsor: Northwell Health

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.

Detailed Description

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..

Study Timeline

• Study Start: 2021-10-28
• Study First Submitted: 2021-11-11
• Study First Submitted QC: 2021-11-11
• Study First Posted: 2021-11-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Speeded Cognitive Training	SCORES (Specific COgnitive Remediation with Support)	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.
Non-Speeded Cognitive Training	SCORES (Specific COgnitive Remediation with Support)	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.

Primary Outcome Measures

Name	Time	Method
Processing Speed domain score from the MATRICS Consensus Cognitive Battery (MCCB)	Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)	Change in processing speed domain score and individual measures within the domain.

Secondary Outcome Measures

Name	Time	Method
Global Functioning: Social (GF:Social) scale (Phase 2/R33 only)	Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)	Change in GF:Social score from baseline to follow up timepoints. The GF:Social scale scores range from 1 to 10 with higher scores representing better social functioning.
SIPS/SOPS: Positive Symptoms (Phase 2/R33 only)	Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)	Change in Total Positive Symptom score from baseline to follow up timepoints. Each of the 5 positive symptoms on the SOPS range from 0-6 (6 indicating a psychotic symptom).

Trial Locations

Locations (1)

Northwell Health- The Zucker Hillside Hospital; 🇺🇸 Glen Oaks, New York, United States