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

Primary Purpose

Psychosis, Prodromal Schizophrenia, Prodromal Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SCORES (Specific COgnitive Remediation with Support)
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Psychosis focused on measuring Clinical High Risk (CHR), Processing Speed, Social Functioning, Social Impairment, Social Skills, Adolescents, Cognitive Remediation

Eligibility Criteria

14 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northwell Health- The Zucker Hillside HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Processing Speed domain score from the MATRICS Consensus Cognitive Battery (MCCB)
Change in processing speed domain score and individual measures within the domain.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
November 11, 2021
Last Updated
June 16, 2023
Sponsor
Northwell Health
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05131035
Brief Title
Targeting Processing Speed Deficits to Improve Social Functioning and Lower Psychosis Risk
Acronym
SCORES
Official Title
Targeting Processing Speed Deficits to Improve Social Functioning and Lower Psychosis Risk in Adolescents at Clinical High Risk for Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2021 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Prodromal Schizophrenia, Prodromal Symptoms
Keywords
Clinical High Risk (CHR), Processing Speed, Social Functioning, Social Impairment, Social Skills, Adolescents, Cognitive Remediation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
No masking
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SCORES (Specific COgnitive Remediation with Support)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Processing Speed domain score from the MATRICS Consensus Cognitive Battery (MCCB)
Description
Change in processing speed domain score and individual measures within the domain.
Time Frame
Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)
Secondary Outcome Measure Information:
Title
Global Functioning: Social (GF:Social) scale (Phase 2/R33 only)
Description
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.
Time Frame
Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)
Title
SIPS/SOPS: Positive Symptoms (Phase 2/R33 only)
Description
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).
Time Frame
Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ricardo E Carrion, Ph.D.
Phone
718-470-8788
Email
rcarrion@northwell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle McLaughlin, M.A.
Phone
718-470-8375
Email
dmclaugh@northwell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara A Cornblatt, Ph.D.
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwell Health- The Zucker Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea M Auther, Ph.D.
Phone
718-470-8147
Email
aauther@northwell.edu
First Name & Middle Initial & Last Name & Degree
Danielle McLaughlin, M.A.
Phone
718-470-8375
Email
dmclaugh@northwell.edu
First Name & Middle Initial & Last Name & Degree
Barbara A Cornblatt, Ph.D.
First Name & Middle Initial & Last Name & Degree
Ricardo E Carrion, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be uploaded to the NIH Data Archive (NDA).
IPD Sharing Time Frame
We plan to make all data collected available as a national resource to the broader scientific community for investigators wishing to pursue their own analyses. Consistent with the NIH policy regarding data sharing, we will share data no later than following acceptance for publication of the main findings from the final dataset, which is expected to occur at the end of year 5. We request that we maintain exclusive access to these data until the end of year 5 to ensure an adequate amount of time for the PIs to conduct analyses and prepare manuscripts for publication. All de-identified data resulting from this NIH-funded award will be submitted to the NIMH Data Archive (NDA) according to this timeline, along with appropriate supporting documentation to enable efficient use of the data by other researchers not involved in the study. Data derived from the proposed study will also be shared through presentation at research conferences and through publication in peer-reviewed journals.
IPD Sharing Access Criteria
Data will be shared with researchers upon request. Other researchers across the world can then request the pseudo-anonymized study data for other research from the NDA. Every researcher (and institutions to which they belong) who requests the pseudo-anonymized study data must promise to keep the data safe. Experts at the NIH will review each request carefully to reduce risks to participant privacy.

Learn more about this trial

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

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