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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Psychosis, Prodromal Schizophrenia, Prodromal Symptoms

Intervention / Treatment
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* Behavioral: SCORES (Specific COgnitive Remediation with Support)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: The study will utilize a Single Group intervention model. All participants will participate in cognitive training with small group support.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm intervention<br>All participants will complete 40 hours of Cognitive Remediation with a mid-point assessment (20 hours/5 weeks) to determine the level of training needed to impact processing speed. | Behavioral: SCORES (Specific COgnitive Remediation with Support)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Functioning, Clinical High Risk (CHR), Processing Speed, Social Impairment, Social Skills, Adolescents, Cognitive Remediation