What is the mechanism of action of this treatment?

Common treatments for prodromal symptoms, such as those studied in the SCORES trial, involve cognitive training exercises and group support. Cognitive training exercises target specific cognitive deficits like processing speed, which is essential for improving social functioning and daily task management. Group support aims to enhance motivation and engagement, providing a supportive environment that encourages treatment adherence and social interaction. These mechanisms are vital for prodromal symptoms patients as they address both cognitive and social challenges, potentially preventing the progression to full-blown psychosis.

What side effects are associated with this type of intervention?

Cognitive training exercises for prodromal symptoms are generally well-tolerated, with mild side effects such as fatigue, frustration, or headaches. Group support interventions may cause emotional discomfort but are typically safe and beneficial for motivation and engagement. Overall, these treatments have minimal side effects compared to pharmacological options.

What prior FDA approvals exist?

The FDA has not specifically approved treatments for prodromal symptoms that directly mirror the Specific Cognitive Remediation with Surround (SCORES) intervention, which combines cognitive training exercises to improve processing speed and group support to boost motivation and engagement. However, cognitive remediation therapies, which aim to improve cognitive functions such as memory, attention, and processing speed, have been explored in various clinical settings. These therapies often include structured cognitive exercises and may be complemented by psychosocial interventions to enhance overall functioning and engagement. While specific FDA approvals for such combined approaches are limited, the principles underlying cognitive remediation and motivational support are widely recognized in the treatment of cognitive deficits and social functioning impairments.

What other types of research exist?

Promising alternatives to SCORES for treating prodromal symptoms include the Neuropsychological Educational Approach to Cognitive Remediation (NEAR), which combines computer-based cognitive training with group sessions, and transcranial direct current stimulation (tDCS), which has shown potential in enhancing cognitive functions and neurocognition. Both approaches aim to improve cognitive deficits and social functioning, similar to SCORES.

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Cognitive Remediation

SCORES for Schizophrenia Risk (SCORES Trial)

N/A

Recruiting

Led By Barbara A Cornblatt, Ph.D.

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Must not have

Significant visual or auditory impairment

Estimated IQ<70

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, mid-treatment (5 weeks), post treatment (10 weeks)

Awards & highlights

Summary

This trial tests the SCORES program, which uses brain training and group support to help adolescents at risk for psychosis. The program aims to improve thinking speed and social skills through engaging exercises and support.

Who is the study for?

This trial is for adolescents showing early signs of psychosis, specifically those who have certain symptoms but haven't been diagnosed with a schizophrenia-spectrum disorder. Participants should be English speakers without significant neurological issues, intellectual disability (IQ<70), major head injury, or severe sensory impairments.

What is being tested?

The SCORES program aims to improve processing speed and social functioning over 10 weeks through cognitive exercises and group support. It's designed for young people at risk of developing schizophrenia or other psychotic disorders and is delivered remotely.

What are the potential side effects?

Since SCORES involves cognitive training and support groups rather than medication, typical drug side effects are not expected. However, participants may experience fatigue or stress from the exercises or emotional discomfort during group discussions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have major issues with my sight or hearing.

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My IQ is estimated to be below 70.

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I have been diagnosed with a schizophrenia-spectrum disorder.

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I have a history of significant brain or nerve disorders.

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I do not speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, mid-treatment (5 weeks), post treatment (10 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, mid-treatment (5 weeks), post treatment (10 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, mid-treatment (5 weeks), post treatment (10 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Processing Speed domain score from the MATRICS Consensus Cognitive Battery (MCCB)

Secondary study objectives

Global Functioning: Social (GF:Social) scale (Phase 2/R33 only)

SIPS/SOPS: Positive Symptoms (Phase 2/R33 only)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Speeded Cognitive TrainingExperimental Treatment1 Intervention

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.

Group II: Non-Speeded Cognitive TrainingActive Control1 Intervention

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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prodromal symptoms, such as those studied in the SCORES trial, involve cognitive training exercises and group support. Cognitive training exercises target specific cognitive deficits like processing speed, which is essential for improving social functioning and daily task management. Group support aims to enhance motivation and engagement, providing a supportive environment that encourages treatment adherence and social interaction. These mechanisms are vital for prodromal symptoms patients as they address both cognitive and social challenges, potentially preventing the progression to full-blown psychosis.

Cognitive Remediation as an Adjunct Treatment for Substance Use Disorders: A Systematic Review.The effects of cognitive remediation on cognitive abilities and real-world functioning among people with bipolar disorder: A systematic review: Special Section on "Translational and Neuroscience Studies in Affective Disorders". Section Editor, Maria Nobile MD, PhD. This Section of JAD focuses on the relevance of translational and neuroscience studies in providing a better understanding of the neural basis of affective disorders. The main aim is to briefly summaries relevant research findings in clinical neuroscience with particular regards to specific innovative topics in mood and anxiety disorders.Computerised training improves cognitive performance in chronic pain: a participant-blinded randomised active-controlled trial with remote supervision.