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Cognitive Remediation for Coordinated Specialty Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03930251
Recruitment Status : Enrolling by invitation
First Posted : April 29, 2019
Last Update Posted : April 7, 2020
Sponsor:
Collaborators:
Columbia University
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Alice Medalia, New York State Psychiatric Institute

Brief 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" and the other that is "partial-remote" with one in-clinic 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" or "partial-remote"). 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.


Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Behavioral: Clinic-Based Cognitive Remediation Behavioral: Partial-Remote Cognitive Remediation Not Applicable

Detailed Description:

At the time of first-episode, most people with schizophrenia have cognitive impairments that significantly contribute to poor functioning. Early intervention with cognitive remediation (CR), an evidence-based skills intervention that targets cognitive processes, is designed to enhance cognition and functional recovery in people identified as having cognitive health needs. Evidence suggests that provision of CR to those in the early stage of schizophrenia, and in the context of rehabilitation services, results in greater cognitive and functional gains.

OnTrackNY (OTNY) is a New York-based Coordinated Specialty Care (CSC) program that provides early psychosis treatment to young people, between 16 and 30 years of age, who have experienced the onset of non-affective psychosis within two years of beginning treatment. CSC programs provide a significant benefit over usual care, but on average 50% of patients remain disabled after two years. OTNY, like many other CSC programs, provides cognitive health evaluation and supportive treatment but does not routinely offer CR. However, evidence suggests that when cognitive disability is promptly addressed, people show increased self-esteem, engagement in the community and sense of well-being. Therefore, the addition of CR to OTNY may allow treatment to proceed at a faster rate, promote more rapid engagement and mitigate challenges experienced by clients in school or work.

This study aims to:

  1. Adapt a 12-week long CR intervention to 2 delivery methods using the input of experts, OnTrackNY mental health clinicians, and clients to improve the acceptability of the intervention content.
  2. Examine whether CR can enhance the cognitive and functional outcomes for people with first episode psychosis (FEP) receiving treatment in a CSC program and identified as having cognitive health needs.
  3. Compare the effectiveness of "in clinic" and "partial-remote" CR delivery approaches.

This study will occur in phases. In Phase 1, CR content and delivery will be adapted using the input of experts, and training manuals will be created for two intervention approaches. Phase 2 will involve training of mental health clinicians at two OnTrackNY programs to add a formal battery of cognitive assessments and adapted CR. One program will be assigned to deliver CR exclusively "in-clinic" and the other "partial-remote" (one in-clinic session per week with out-of-clinic independent cognitive practice). Following quality improvement/program evaluation procedures, the investigators will refine CR based on feedback from providers and clients. Phase 3 will involve nine OnTrackNY programs where clinicians will be trained by researchers to conduct the formal cognitive assessment battery and CR, if applicable. Three programs will be randomly assigned to provide treatment as usual (TAU) and six will be assigned to TAU and CR (either "in-clinic" or "partial-remote").

Referral for cognitive health services will follow routine clinical practice through which clients and their clinicians document cognitive health needs and decide what intervention suits their needs. Clients will be given the option of enrolling in the program's CR intervention. Client characteristics, CR enrollment and outcomes will be made available for quality improvement monitoring and program evaluation in de-identified form. The investigators will examine outcomes for clients identified as having cognitive health needs. To address whether adding CR improves functional outcomes in CSC programs, the investigators will compare measures of community functioning and psychiatric symptom severity across groups. Functional outcome measures will be examined for the time most proximal to CR enrollment and every three months thereafter until study end (range 3-12 months of follow-up depending upon rolling enrollment). Cognition will be measured before and after completion of CR (an average of 3 months) to compare the effectiveness of the two CR delivery approaches and examine whether cognitive improvement is associated with improvement in functioning.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does the Addition of Cognitive Remediation to Coordinated Specialty Care Services Improve Functional Outcome
Actual Study Start Date : June 3, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Treatment as Usual
This is the standard coordinated specialty care treatment (without cognitive remediation) that is provided to OnTrackNY clients. This treatment involves psychiatric treatment, employment and educational support, substance abuse treatment, family education and support, CBT-informed individual psychotherapy, and cognitive health support services as needed.
Experimental: Clinic-Based Cognitive Remediation
Clinic-based cognitive remediation consists of twice weekly group-based and clinician-led sessions.
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.

Experimental: Partial-Remote Cognitive Remediation
Partial-Remote cognitive remediation consists of one weekly group-based, clinician-led session plus independent cognitive practice.
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.




Primary Outcome Measures :
  1. Change in occupational functioning [ Time Frame: At study enrollment and every 3 months through study end, range of time frame 3-12 months ]
    Change in occupational functioning will be measured with the MIRECC Global Assessment of Functioning (GAF) Occupational Functioning scale. A clinician rates occupational functioning according to the client's primary role (worker, student, or not in labor force/homemaker) on a scale of 1-100 where a higher rating indicates better functioning.

  2. Change in social functioning [ Time Frame: At study enrollment and every 3 months through study end, range of time frame 3-12 months ]
    Change in social functioning will be measured with the MIRECC Global Assessment of Functioning (GAF) Social Functioning scale. A clinician rates the client's average social functioning during the past month on a scale of 1-100 where higher scores indicate better functioning.

  3. Change in psychiatric symptoms [ Time Frame: At study enrollment and every 3 months through study end, range of time frame 3-12 months ]
    Change in symptoms will be measured with the MIRECC Global Assessment of Functioning (GAF) Symptoms scale. A clinician rates psychiatric symptom severity on a scale of 1-100 where a higher rating indicates fewer or less severe psychiatric symptoms.


Secondary Outcome Measures :
  1. Change in Average Neurocognition [ Time Frame: Before and after completion of cognitive remediation, an average of 3 months ]
    Neurocognition will be measured with subtests from the Brief Assessment of Cognition in Schizophrenia (BACS) assessing verbal memory, working memory, speed of processing, and executive function and the Continuous Performance Test - Identical Pairs (CPT-IP) for attention/vigilance. All scores will be converted to standardized T scores and averaged together to formulate one measure, Average Neurocognition. The secondary outcome measure will be change in Average Neurocognition from pre to post treatment such that a higher value represents a better outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrolled in a participating OTNY cognitive remediation program

Exclusion Criteria:

  • Not eligible to be enrolled in a participating OTNY cognitive remediation program

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930251


Locations
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United States, New York
The Institute for Family Health
Bronx, New York, United States, 10032
Montefiore Medical Center
Bronx, New York, United States, 10467
Kings County Hospital Center
Brooklyn, New York, United States, 11203
Services for the Underserved
Brooklyn, New York, United States, 11238
Bellevue Hospital Center
New York, New York, United States, 10016
Washington Heights Community Service
New York, New York, United States, 10032
Elmhurst Hospital Center
Queens, New York, United States, 11373
Rochester Psychiatric Center
Rochester, New York, United States, 14610
Staten Island University Hospital
Staten Island, New York, United States, 10309
Sponsors and Collaborators
New York State Psychiatric Institute
Columbia University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Alice Medalia, PhD New York State Psychiatric Institute
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Responsible Party: Alice Medalia, Professor of Medical Psychology (in Psychiatry) at CUMC, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03930251    
Other Study ID Numbers: 7700
1R34MH118318-01 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All materials necessary to replicate the adapted cognitive remediation (CR) intervention will be prepared for public sharing. This includes the menu of web-based cognitive exercises employed by CR clinicians and treatment manual for bridging group verbal discussions. De-identified program evaluation data will be made available for research to investigators working under a Federal Wide Assurance who meet security measures and data use agreement criteria associated with public repositories including the National Database for Clinical Trials related to Mental Illness (NDCT). De-identified data will include demographic data, and raw data derived from occupational, social, symptom, and cognitive measures.
Time Frame: A list of all data expected to be collected in the project will be submitted to the NDCT within 6 months of award. Subsequently, descriptive and raw data will be submitted on a semi-annual basis. Unpublished de-identified data will be submitted prior to study completion and will be shared within one year after project completion, or when the data are published, whichever is earlier.
Access Criteria: Data in NIH repositories may be accessed through the NIH Data Access Committee which reviews data access and submission requests.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alice Medalia, New York State Psychiatric Institute:
Cognitive Remediation
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders