SCORES for Schizophrenia Risk

(SCORES Trial)

Overseen by Barbara A Cornblatt, Ph.D.

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwell Health

Disqualifiers: Schizophrenia, CNS disorder, IQ<70, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the SCORES treatment for schizophrenia risk?

Research shows that cognitive remediation (a therapy to improve thinking skills) can lead to small-to-moderate improvements in thinking and daily functioning for people with schizophrenia. Programs that include group discussions and strategy coaching are especially effective, suggesting that similar approaches in the SCORES treatment might also be beneficial. ^{1 2 3 4 5}

Is the SCORES treatment generally safe for humans?

The studies on cognitive remediation (CR), which is similar to SCORES, show that it is generally safe for people with schizophrenia, as the drop-out rates were comparable to usual treatments, indicating no major safety concerns. ^{1 6 7 8 9}

How is the SCORES treatment for schizophrenia different from other treatments?

The SCORES treatment is unique because it focuses on cognitive remediation, which aims to improve cognitive skills and social adjustment in people with schizophrenia by using specific cognitive exercises and strategies to enhance brain function and social skills. ^{1 2 7 10 11}

Research Team

Barbara A Cornblatt, Ph.D.

Principal Investigator

Northwell Health

Eligibility Criteria

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.

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

Significant head injury

I have major issues with my sight or hearing.

Significant substance abuse

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 40 hours of Cognitive Remediation over 10 weeks, with a mid-point assessment at 5 weeks to evaluate the impact on processing speed and social function.

10 weeks

Remote sessions

Follow-up

Participants are monitored for changes in processing speed and social functioning after the treatment phase.

4 weeks

Treatment Details

Interventions

• SCORES (Cognitive Remediation)

Trial Overview 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.

Participant Groups

Group I: Speeded Cognitive Training Experimental Treatment 1 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 Training Active Control 1 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.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Michael Dowling

Northwell Health

Chief Executive Officer since 2002

Bachelor's and Master's degrees from University College Cork, Ireland

Dr. David Battinelli

Northwell Health

Chief Medical Officer since 2022

MD from Georgetown University School of Medicine

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Findings from Research

Cognitive remediation (CR) for schizophrenia has been shown to produce small-to-moderate improvements in cognitive skills and functioning, based on a meta-analysis of 73 randomized controlled trials involving 4594 participants.

CR programs that incorporate 'bridging' discussions to apply cognitive skills in real life and strategy-coaching for episodic memory yield larger improvements, suggesting that these elements enhance the effectiveness of CR interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Meta-analysis of Cognitive Remediation for Schizophrenia: Efficacy and the Role of Participant and Treatment Factors. Lejeune, JA., Northrop, A., Kurtz, MM.[2022]

In a study of 88 early course schizophrenia outpatients, it was found that premorbid sociality significantly influenced how well patients responded to Cognitive Enhancement Therapy (CET) compared to Enriched Supportive Therapy (EST) over 18 months.

Patients with higher premorbid sociality showed greater improvements in social adjustment with CET, while those with lower premorbid sociality benefited more from EST, suggesting that understanding a patient's social history can help tailor effective treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Premorbid Sociality Moderates Social Adjustment Change during Cognitive Enhancement Therapy for Adults with Early Schizophrenia. Wojtalik, JA., Flores, AT., Keshavan, MS., et al.[2023]

Cognitive remediation (CR) shows promise in improving cognitive deficits in schizophrenia, especially when combined with other therapies, as supported by six meta-analyses.

CR interventions can lead to structural and functional changes in important brain areas, and factors like attention, motivation, and clinician expertise are crucial for a positive treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive remediation for schizophrenia: current status, biological correlates and predictors of response. Kurtz, MM.[2018]

A study involving 40 individuals with schizophrenia demonstrated that cognitive remediation using the NEAR approach led to significant improvements in cognitive functions such as verbal and visual memory, attention, and executive functioning, with effects lasting up to 4 months after treatment.

Improvements in cognitive abilities were also associated with better social and occupational outcomes, indicating that cognitive remediation can have a broader impact on the quality of life for individuals with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of cognitive remediation in schizophrenia. Hodge, MA., Siciliano, D., Withey, P., et al.[2021]

A new computer-based cognitive remediation intervention for schizophrenia has been developed, focusing on engaging multiple cognitive skills and providing personalized support from therapists, which is currently being tested in a randomized trial with patients completing 24 sessions.

Initial results are promising, showing that patients are receptive to the tasks and are willing to participate regularly, although it is too early to determine the overall effectiveness in improving cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of a computer-assisted cognitive remediation program for patients with schizophrenia. Bellack, AS., Dickinson, D., Morris, SE., et al.[2018]

Cognitive remediation (CR) significantly reduces negative symptoms in people with schizophrenia, with a moderate effect size of -0.30 immediately post-therapy and -0.36 at follow-up, based on a meta-analysis of 45 studies involving 2511 participants.

CR was found to be more effective than treatment as usual (TAU) and TAU plus active control, indicating that CR can be a valuable intervention for addressing negative symptoms, which are often overlooked in schizophrenia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive remediation for negative symptoms of schizophrenia: A network meta-analysis. Cella, M., Preti, A., Edwards, C., et al.[2022]

Cognitive remediation strategies for schizophrenia have shown improvements in working memory, emotion perception, and executive function, indicating that targeted cognitive exercises can effectively engage underfunctioning brain systems.

Cognitive adaptation interventions have been linked to better symptoms, psychosocial status, and reduced relapse rates, suggesting that modifying the environment can help patients manage their cognitive deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurocognitive rehabilitation for schizophrenia. Kurtz, MM.[2019]

Cognitive remediation treatment over 12 weeks significantly improved processing speed, executive functions, and real-world work skills in individuals with early-course schizophrenia (within 5 years of first episode) compared to those with long-term illness (more than 15 years).

The study suggests that earlier intervention in schizophrenia leads to more meaningful improvements in cognitive function and everyday functioning, highlighting the importance of cognitive remediation as a tool for early treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive remediation in schizophrenia: efficacy and effectiveness in patients with early versus long-term course of illness. Bowie, CR., Grossman, M., Gupta, M., et al.[2022]

Cognitive remediation (CR) in early schizophrenia showed significant improvements in functioning and symptoms, with effect sizes of 0.18 and 0.19 respectively, based on a systematic review of 11 trials involving 615 participants.

While CR did not significantly improve overall global cognition, it did show a positive effect on verbal learning and memory, suggesting that targeted cognitive interventions may be beneficial, especially when combined with psychiatric rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of cognitive remediation in early schizophrenia. Revell, ER., Neill, JC., Harte, M., et al.[2022]

In a study of 32 patients with schizophrenia undergoing a computer-based cognitive training program, baseline cognitive impairment did not significantly predict individual success in cognitive remediation, suggesting that other factors may play a more critical role.

The study found that better baseline cognitive abilities were linked to a higher percentage of tasks with ceiling effects, indicating that not adjusting task difficulty to match patients' cognitive levels could hinder the effectiveness of cognitive remediation more than the level of cognitive impairment itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of performance improvements within a cognitive remediation program for schizophrenia. Scheu, F., Aghotor, J., Pfueller, U., et al.[2018]

Cognitive deficits are a core feature of schizophrenia and significantly impact daily functioning, yet current treatments do not effectively address these issues.

Cognitive remediation programs, such as cognitive enhancement therapy, show promise in improving cognitive and social functions in schizophrenia by focusing on principles like intensity, duration, and individualized training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive remediation in schizophrenia. Kaneko, Y., Keshavan, M.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Meta-analysis of Cognitive Remediation for Schizophrenia: Efficacy and the Role of Participant and Treatment Factors. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Premorbid Sociality Moderates Social Adjustment Change during Cognitive Enhancement Therapy for Adults with Early Schizophrenia. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Cognitive remediation for schizophrenia: current status, biological correlates and predictors of response. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of cognitive remediation in schizophrenia. [2021]

5. Israel pubmed.ncbi.nlm.nih.gov

The development of a computer-assisted cognitive remediation program for patients with schizophrenia. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Cognitive remediation for negative symptoms of schizophrenia: A network meta-analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Neurocognitive rehabilitation for schizophrenia. [2019]

8. Australia pubmed.ncbi.nlm.nih.gov

Cognitive remediation in schizophrenia: efficacy and effectiveness in patients with early versus long-term course of illness. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of cognitive remediation in early schizophrenia. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

Predictors of performance improvements within a cognitive remediation program for schizophrenia. [2018]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Cognitive remediation in schizophrenia. [2022]