Clinical trial NCT05131035: Targeting Processing Speed Deficits to Improve Social Functioning and Lower Psychosis Risk
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
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Prodromal Schizophrenia
Prodromal Symptoms
Keywords: Clinical High Risk (CHR)
Processing Speed
Social Functioning
Social Impairment
Social Skills
Adolescents
Cognitive Remediation
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-11-23
Enrollment: 54
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The R33 study design will utilize a randomized intervention model. All participants will participate in cognitive training with small group support.One group will complete speeded cognitive training tasks and the other group will complete non-speeded cognitive training tasks.
Primary purpose: OTHER

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 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..

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.

Primary outcomes:
measure: Processing Speed domain score from the MATRICS Consensus Cognitive Battery (MCCB)
timeFrame: Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)
Secondary outcomes:
measure: Global Functioning: Social (GF:Social) scale (Phase 2/R33 only)
timeFrame: Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)
measure: SIPS/SOPS: Positive Symptoms (Phase 2/R33 only)
timeFrame: Baseline, Mid-Treatment (5 weeks), Post Treatment (10 weeks)
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: Northwell Health- The Zucker Hillside Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: Barbara A Cornblatt, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: