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Recruiting NCT05131035

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

No phase Interventional Psychosis Prodromal Schizophrenia Prodromal Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SCORES (Specific COgnitive Remediation with Support).
Who it may be relevant to
Registry conditions: Psychosis, Prodromal Schizophrenia, Prodromal Symptoms. Basic parameters: 14 years — 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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..

Interventions

  • 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 c

Primary outcome measures

  • Processing Speed domain score from the MATRICS Consensus Cognitive Battery (MCCB) [Time frame: Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)]
Secondary outcome measures (2)
  • Global Functioning: Social (GF:Social) scale (Phase 2/R33 only) [Time frame: Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)]
  • SIPS/SOPS: Positive Symptoms (Phase 2/R33 only) [Time frame: Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

United States · 1 center
  • Northwell Health- The Zucker Hillside Hospital — Glen Oaks

Identifiers

NCT: NCT05131035 · 21-0832, 23-0500 · R61MH123574 · R33MH123574

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗