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

Psychosis Clinical Trial

— SCORES  

Official title:

Targeting Processing Speed Deficits to Improve Social Functioning and Lower Psychosis Risk in Adolescents at Clinical High Risk for Psychosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05131035
• Other study ID #: 21-0832, 23-0500
• Secondary ID: R61MH123574R33MH
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2021
• Est. completion date: May 31, 2026

Study information

• Verified date: March 2024
• Source: Northwell Health
• Contact: Ricardo E Carrion, Ph.D.
• Phone: 718-470-8788
• Email: rcarrion[@]northwell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 current active R61 phase, presented here, all participants will 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. Employing the optimal dose of SCORES (20 or 40 hours) found in the R61, we will apply for the R33 (Phase 2) to allow for a replication and assessment of specificity of the targeted intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Prodromal Schizophrenia
• Prodromal Symptoms
• Psychosis
• Psychotic Disorders
• Schizophrenia

Intervention

Behavioral:
• 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 results will inform a potential second study (R33) employing the optimal dose of SCORES (20 or 40 hours) found in the R61. The second future study will allow for a replication and assessment of specificity of the targeted intervention.

Locations

Country	Name	City	State
United States	Northwell Health- The Zucker Hillside Hospital	Glen Oaks	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Global Functioning: Social (GF:Social) scale (Phase 2/R33 only)	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.	Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)
Secondary	SIPS/SOPS: Positive Symptoms (Phase 2/R33 only)	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).	Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)