Cognitive Remediation for Coordinated Specialty Care

NCT03930251 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2025-10-07

No results posted yet for this study

Summary

Cognitive remediation (CR) is an evidence-based behavioral skills intervention that targets the cognitive processes underlying functioning in everyday life. It can be used as part of early intervention to reduce cognitive deficits evident at the first episode of psychosis, and has the potential to impact recovery and quality of life. Across Coordinated Specialty Care (CSC) programs, about half of early psychosis participants do not achieve sustained vocational, educational, and/or social recovery; adding CR to CS programs could improve these outcomes. However, models of CR need to be adapted to meet the developmental needs of a younger population and to better fit the CSC model of service delivery. This study of CR implementation will be conducted within the context of OnTrackNY, a network of first-episode psychosis programs that currently offers basic cognitive health evaluation and supportive treatment but not CR.

Intervention content will be designed and refined based on input from multiple stakeholders. The study will assess two delivery approaches to CR, one that delivers CR exclusively "in-clinic/clinician-led" and the other that is "partial-remote/independent" with one in-clinic/clinician-led session per week plus out-of-clinic independent cognitive practice. Nine OnTrackNY programs will be selected and OnTrackNY clinicians will be trained to conduct a cognitive assessment battery and CR. Three programs will be randomly assigned to provide treatment as usual (TAU) and six programs will be randomly assigned to provide both TAU and CR (either "in-clinic/clinician-led" or "partial-remote/independent"). Using de-identified data collected routinely by OnTrackNY for quality improvement/program evaluation, the investigators will examine whether the addition of CR improves functional outcomes for clients with first-episode psychosis, compare the effectiveness of CR delivery methods, and explore whether cognitive improvement is associated with improvement in functioning.

Conditions

Interventions

BEHAVIORAL

Clinic-Based Cognitive Remediation

Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition and bridge newly learned cognitive skills to everyday life. Sessions are led twice weekly by a clinician in small groups.

BEHAVIORAL

Partial-Remote Cognitive Remediation

Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition and bridge newly learned cognitive skills to everyday life. Sessions are led once weekly by a clinician in small groups and clients gain additional practice by accessing clinician-assigned computer-based exercises independently.

Sponsors & Collaborators

  • Columbia University

    collaborator OTHER
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Alice Medalia, PhD · New York State Psychiatric Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2023-10-31
Completion
2026-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03930251 on ClinicalTrials.gov