SchizophreniaNCT03930251
Cognitive Remediation for Coordinated Specialty Care
A study testing Clinic-Based Cognitive Remediation and Partial-Remote Cognitive Remediation in people with Schizophrenia and Schizoaffective Disorder, run by New York State Psychiatric Institute at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Clinic-Based Cognitive Remediation and Partial-Remote Cognitive Remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Jun 2019to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Enrolled in a participating OTNY cognitive remediation program
Who cannot join
- Not eligible to be enrolled in a participating OTNY cognitive remediation program
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Kings County Hospital Center
Brooklyn, New York, 11203
Services for the Underserved
Brooklyn, New York, 11238
Bellevue Hospital Center
New York, New York, 10016
Washington Heights Community Service
New York, New York, 10032
Elmhurst Hospital Center
Queens, New York, 11373
Rochester Psychiatric Center
Rochester, New York, 14610
Staten Island University Hospital
Staten Island, New York, 10309
The Institute for Family Health
The Bronx, New York, 10032
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Does the Addition of Cognitive Remediation to Coordinated Specialty Care Services Improve Functional Outcome
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.
Read the 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:
- 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.
- 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.
- Compare the effectiveness of "in clinic/clinician-led" and "partial-remote/independent" 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" with the aid of a clinician and the other "partial-remote/independent" (one in-clinic session per week with 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/clinician-led" or "partial-remote/independent").
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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Clinic-Based Cognitive Remediation, Partial-Remote Cognitive Remediation
- Keywords
- Cognitive Remediation
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic-Based Cognitive RemediationBehavioural
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.
Partial-Remote Cognitive RemediationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | No intervention | 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. |
| Clinic-Based Cognitive Remediation | Experimental | Clinic-based cognitive remediation consists of twice weekly group-based and clinician-led sessions. Receives: Behavioral: Clinic-Based Cognitive Remediation |
| Partial-Remote Cognitive Remediation | Experimental | Partial-Remote cognitive remediation consists of one weekly group-based, clinician-led session plus independent cognitive practice. Receives: Behavioral: Partial-Remote Cognitive Remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in occupational functioning
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.
Measured: At study enrollment and every 3 months through study end, range of time frame 3-12 months
Change in social functioning
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.
Measured: At study enrollment and every 3 months through study end, range of time frame 3-12 months
Change in psychiatric symptoms
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.
Measured: At study enrollment and every 3 months through study end, range of time frame 3-12 months
Secondary outcomes (1)
Change in Average Neurocognition
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.
Measured: Before and after completion of cognitive remediation, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start1 Jun 2019
- Primary completion31 Oct 2023
- Study completion31 Aug 2026 (estimated)
Why it stopped: U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Medalia, New York State Psychiatric Institute
- Investigators
- Alice Medalia, PhD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930251
- Sponsor's protocol ID
- 7700
- Other IDs
- 1R34MH118318-01
- Status last verified
- Oct 2025
- First submitted
- 5 Apr 2019
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Addition of Cognitive Remediation to Coordinated Specialty Care Services Improve Functional Outcome
- ClinicalTrials.gov ID
- NCT03930251
- Acronym / sponsor ID
- 7700
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Cognitive Remediation
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023.
- Enrolment
- 117 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Columbia University, National Institute of Mental Health (NIMH)
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- Compare the effectiveness of "in clinic/clinician-led" and "partial-remote/independent" 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" with the aid of a clinician and the other "partial-remote/independent" (one in-clinic session per week with 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/clinician-led" or "partial-remote/independent").
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | –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. |
| Clinic-Based Cognitive Remediation | Experimental | Behavioral: Clinic-Based Cognitive RemediationClinic-based cognitive remediation consists of twice weekly group-based and clinician-led sessions. |
| Partial-Remote Cognitive Remediation | Experimental | Behavioral: Partial-Remote Cognitive RemediationPartial-Remote cognitive remediation consists of one weekly group-based, clinician-led session plus independent cognitive practice. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Enrolled in a participating OTNY cognitive remediation program
Key exclusion criteria (1 listed)
- Not eligible to be enrolled in a participating OTNY cognitive remediation program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinic-Based Cognitive RemediationComputer-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. | Behavioural | Clinic-Based Cognitive Remediation |
| Partial-Remote Cognitive RemediationComputer-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. | Behavioural | Partial-Remote Cognitive Remediation |
Primary outcome
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.
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.
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.
1 secondary outcome
Change in Average Neurocognition
Time frame: Before and after completion of cognitive remediation, an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Medalia, PhD principal investigator
New York State Psychiatric Institute
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinic-Based Cognitive Remediation and Partial-Remote Cognitive Remediation in people with Schizophrenia and Schizoaffective Disorder, run by New York State Psychiatric Institute at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in occupational functioning (time frame: At study enrollment and every 3 months through study end, range of time frame 3-12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.