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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
First received
Last updated
Start date October 28, 2021
Est. completion date May 31, 2026

Study information

Verified date May 2024
Source Northwell Health
Contact Ricardo E Carrion, Ph.D.
Phone 718-470-8788
Email rcarrion@northwell.edu
Is FDA regulated No
Health authority
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 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..


Recruitment information / eligibility

Status Recruiting
Enrollment 54
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.

Study Design


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 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.

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)
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