SchizophreniaRAISE ETPNCT01321177
An Integrated Program for the Treatment of First Episode of Psychosis
A study testing Integrated Treatment and Community Care in people with Schizophrenia and Schizoaffective Disorder, run by Northwell Health at 33 sites in United States.
Trial summary
The purpose of this study is to determine how services should be provided to reduce symptoms and improve life functioning for adolescents and adults who have been recently diagnosed with schizophrenia. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
- What is being tested?
- Integrated Treatment and Community Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 33 sitesUnited States
- Study dates
- Jul 2010to Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Confirmed SCID DSM-IV clinical diagnosis by trained remote clinical assessor of:
- schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder NOS
- Any duration of untreated psychosis
- Any ethnicity
- Ability to participate in research assessments in English
- Ability to provide fully informed consent (assent for those under age 18)
Who cannot join
- Inability to understand what research participation entails or correctly answer the questions about research participation that are part of the Study Information Review and provide fully informed consent
- More than 4 months of prior cumulative treatment with antipsychotic medications
- Diagnosis of bipolar disorder, psychotic depression or substance-induced psychotic disorder
- Current psychotic disorder due to a general medical condition
- Current neurological disorders that would affect diagnosis or prognosis. These would include, but are not limited to seizure disorders, dementing or degenerative disorders, lesions or substantial congenital abnormalities. In most cases, disorders such as headache disorders would not require protocol exclusion
- Clinically significant head trauma
- Any other serious medical condition that in the opinion of the investigator would seriously impair functioning making the patient unsuitable for the trial
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
University of New Mexico Department of Psychiatry UNM Health Sciences Center
Albuquerque, New Mexico, 87131
Lehigh Valley Hospital Mental Health Clinic
Allentown, Pennsylvania, 18104
Catholic Social Services of Washtenaw County (CSSW)
Ann Arbor, Michigan, 48108
Central Fulton Community Mental Health Center
Atlanta, Georgia, 30303
Cobb County Community Services Board
Austell, Georgia, 30168
Howard Center
Burlington, Vermont, 05401
South Shore Mental Health Center
Charlestown, Rhode Island, 02813
Burrell Behavioral Health
Columbia, Missouri, 65203
Mental Health Center of Denver
Denver, Colorado, 80220
Saint Clare's Hospital
Denville, New Jersey, 07834
Eyerly Ball
Des Moines, Iowa, 50309
Human Development Center
Duluth, Minnesota, 55805
PeaceHealth Oregon/Lane County Behavioral Health Services
Eugene, Oregon, 97401
Henderson Mental Health Center
Fort Lauderdale, Florida, 33319
Park Center
Fort Wayne, Indiana, 46805
Touchstone Innovare
Grand Rapids, Michigan, 49503
Pine Belt Mental Health Clinic
Hattiesburg, Mississippi, 39403
Terrebonne Mental Health Center
Houma, Louisiana, 70360
UMKC School of Pharmacy
Kansas City, Missouri, 64108
Clinton-Eaton-Ingham Community Mental Health Authority
Lansing, Michigan, 48910
River Parish Mental Health Center
Laplace, Louisiana, 70068
Community Mental Health Center, Inc.
Lawrenceburg, Indiana, 47025
Community Mental Health Center of Lancaster County
Lincoln, Nebraska, 68502
The Mental Health Center of Greater Manchester
Manchester, New Hampshire, 03101
North Point Health and Wellness
Minneapolis, Minnesota, 55411
Greater Nashua Mental Health Center @ Community Council
Nashua, New Hampshire, 03060
Life management Center of Northwest Florida
Panama City, Florida, 32405
The Providence Center
Providence, Rhode Island, 02904
San Fernando Mental Health Center
San Fernando, California, 91344
Santa ClaritaMental Health Center
Santa Clarita, California, 91355
Burrell Behavioral Health
Springfield, Missouri, 65802
Community Alternatives
St Louis, Missouri, 63110
United Services Inc.
Willimantic, Connecticut, 06226
About this study
Official title: Recovery After an Initial Schizophrenia Episode (RAISE): RAISE Early Treatment Program
The purpose of this study is to determine how services should be provided to reduce symptoms and improve life functioning for adolescents and adults who have been recently diagnosed with schizophrenia.
Read the detailed description
Schizophrenia is a major mental illness characterized by psychosis, negative symptoms (e.g., apathy, social withdrawal, anhedonia), and cognitive impairment. Depression and substance abuse commonly co-occur. These individuals have impaired functioning in the areas of work, school, parenting, self-care, independent living, interpersonal relationships, and leisure time. Among adult psychiatric disorders, schizophrenia is the most disabling, and its treatment accounts for a disproportionate share of mental health services.
This study is part of the National Institute of Mental Health's Recovery After an Initial Schizophrenia Episode (RAISE) Project. The RAISE Project seeks to fundamentally change the trajectory and prognosis of schizophrenia through coordinated and aggressive treatment in the earliest stages of illness. This study, the RAISE Early Treatment Program (ETP), is one of the two independent research studies that NIMH has funded to conduct the NIMH RAISE Project. ETP is being supported in whole or in part with Federal funds from the American Recovery and Reinvestment Act of 2009 and the NIMH, National Institutes of Health, Department of Health and Human Services.
The ETP study aims to compare two early treatment interventions for adolescents and adults experiencing a first episode of psychosis. The clinical centers have been randomly allocated to offer one of the two treatment programs. Both treatment interventions are designed to provide a person with treatment soon after he or she experiences the early signs of schizophrenia. Participants will be offered mental health services such as medication and psychosocial therapy. These strategies are all aimed at promoting symptom reduction and improving life functioning. Participation in this study will last between 2 and 3 years. All participants will first undergo an initial videoconference interview to confirm a diagnosis of schizophrenia, schizoaffective disorder, psychosis NOS, brief psychotic disorder, or schizophreniform disorder. Eligible participants will then be offered mental health services.
In addition to the mental health services, participants will participate in a series of research interviews. Participants will be interviewed every 3 months for the first 6 months and then every 6 months for up to 3 years. At the research visit, participants will complete an interview about their symptoms and general quality of life, complete questions about experiences with their illness, their vital signs will be measured, and a blood draw will be collected. At the initial, 12 and 24 month visits, participants will also complete a brief test that assesses skills such as memory, attention and problem solving. Participants will also have monthly telephone interviews about their illness and services that they have received.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Brief Psychotic Disorder, Psychotic Disorder NOS
- Being tested
- Integrated Treatment, Community Care
- Keywords
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Brief Psychotic Disorder, Psychotic Disorder NOS, First Episode
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated TreatmentBehavioural
Integrated program of treatments and services delivered by a coordinated team of providers that includes:
- education about schizophrenia and its treatment for the participants and their family members
- medication for symptoms and preventing relapse that uses a computerized decision support system
- strategies for managing the illness and building personal resilience
- help getting back to school or work using a supported employment/education model
Community CareBehavioural
Standard mental health treatments and services offered at the local agency that may include :
- medication for symptoms and preventing relapse
- psychosocial therapy which may include a range of behavioral treatments and supportive services
- Case management
| Study group | Role | What they receive |
|---|---|---|
| Integrated Treatment | Experimental | Integrated program of treatments and services delivered by a coordinated team of providers. Receives: Behavioral: Integrated Treatment |
| Community Care | Active comparator | Standard mental health treatments and services offered at the local agency. Receives: Behavioral: Community Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time
This scale measures psychosocial functioning and behavior in people with schizophrenia. The scale contains 21 items rated 0 (no or minimal functioning) to 6 (normal functioning). The results are reported as the total score with a range from 0 to 126. Higher scores indicate a better outcome.
Measured: Baseline, Month 6, month 12, month 18 and month 24
Secondary outcomes (3)
Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score
This measures the presence and severity of symptoms of schizophrenia. The scales contains 30 items rated 1 (absent) to 7 (extreme). The results are reported in total score with a range of 30 to 210. Higher scores indicate a worse outcome.
Measured: Measured at baseline, month 6, month 12, month 18, and month 24
Calgary Depression Scale
This scale is designed to assess depression in people with schizophrenia. The scale contains 9 items rated 0 (absent) to 3 (severe). The total score is reported and a higher value indicates a worse outcome. Total scores can range from 0 to 27. The data is reported as the estimated mean of the total score.
Measured: Measured at baseline, month 6, month 12, month 18, and month 24
Service Use Rating Form (SURF)
Measures of treatment services used
Measured: Measured at baseline and then monthly for months 1 through 24; reported as the monthly mean
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startJul 2010
- Primary completionJul 2014
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- State University of New York - Downstate Medical Center, University of North Carolina, Chapel Hill, University of California, Los Angeles, Dartmouth-Hitchcock Medical Center, Research Foundation for Mental Hygiene, Inc., National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, John Kane, Northwell Health
- Investigators
- John Kane, MD, Principal investigator, Feinstein Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321177
- Sponsor's protocol ID
- HHSN271200900019C
- Other IDs
- HHSN271200900019C
- Acronym
- RAISE ETP
- Status last verified
- Oct 2021
- First submitted
- 27 Jan 2011
- Last updated
- 26 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
McCarthy JM, Dow JF, Shepherd JM, Mueser KT. Longitudinal effects of lifetime trauma exposure and childhood sexual trauma by gender in individuals with first episode psychosis. Br J Clin Psychol. 2026 Sep 21. doi: 10.1111/bjc.70099. Online ahead of print.
PubMed 42768802Scanlon F, Mueser KT, Cather C. Correlates and Predictors of Criminal Legal Involvement in People With First-Episode Psychosis. J Clin Psychiatry. 2026 Mar 30;87(2):25m15991. doi: 10.4088/JCP.25m15991.
PubMed 41920015Mueser KT, Sussman RF, DeTore NR, Eberlin ES, McGurk SR. The impact of early intervention for first episode psychosis on cognitive functioning. Schizophr Res. 2023 Oct;260:132-139. doi: 10.1016/j.schres.2023.07.021. Epub 2023 Aug 30.
PubMed 37657279Hong SI, Bennett D, Rosenheck RA. Gender differences in outcomes of early intervention services for first episode psychosis. Early Interv Psychiatry. 2023 Jul;17(7):715-723. doi: 10.1111/eip.13367. Epub 2023 Jan 9.
PubMed 36623822Bornheimer LA, Cobia DJ, Li Verdugo J, Holzworth J, Smith MJ. Clinical insight and cognitive functioning as mediators in the relationships between symptoms of psychosis, depression, and suicide ideation in first-episode psychosis. J Psychiatr Res. 2022 Mar;147:85-93. doi: 10.1016/j.jpsychires.2022.01.006. Epub 2022 Jan 5.
PubMed 35026597Bornheimer LA, Wojtalik JA, Li J, Cobia D, Smith MJ. Suicidal ideation in first-episode psychosis: Considerations for depression, positive symptoms, clinical insight, and cognition. Schizophr Res. 2021 Feb;228:298-304. doi: 10.1016/j.schres.2020.12.025. Epub 2021 Jan 23.
PubMed 33493778Bornheimer LA, Tarrier N, Brinen AP, Li J, Dwyer M, Himle JA. Longitudinal predictors of stigma in first-episode psychosis: Mediating effects of depression. Early Interv Psychiatry. 2021 Apr;15(2):263-270. doi: 10.1111/eip.12935. Epub 2020 Feb 12.
PubMed 32052566Robinson DG, Schooler NR, Rosenheck RA, Lin H, Sint KJ, Marcy P, Kane JM. Predictors of Hospitalization of Individuals With First-Episode Psychosis: Data From a 2-Year Follow-Up of the RAISE-ETP. Psychiatr Serv. 2019 Jul 1;70(7):569-577. doi: 10.1176/appi.ps.201800511. Epub 2019 May 14.
PubMed 31084291Nuttall AK, Thakkar KN, Luo X, Mueser KT, Glynn SM, Achtyes ED, Kane JM. Longitudinal associations of family burden and patient quality of life in the context of first-episode schizophrenia in the RAISE-ETP study. Psychiatry Res. 2019 Jun;276:60-68. doi: 10.1016/j.psychres.2019.04.016. Epub 2019 Apr 16.
PubMed 31026764Mueser KT, Meyer-Kalos PS, Glynn SM, Lynde DW, Robinson DG, Gingerich S, Penn DL, Cather C, Gottlieb JD, Marcy P, Wiseman JL, Potretzke S, Brunette MF, Schooler NR, Addington J, Rosenheck RA, Estroff SE, Kane JM. Implementation and fidelity assessment of the NAVIGATE treatment program for first episode psychosis in a multi-site study. Schizophr Res. 2019 Feb;204:271-281. doi: 10.1016/j.schres.2018.08.015. Epub 2018 Aug 20.
PubMed 30139553Bornheimer LA. Suicidal Ideation in First-Episode Psychosis (FEP): Examination of Symptoms of Depression and Psychosis Among Individuals in an Early Phase of Treatment. Suicide Life Threat Behav. 2019 Apr;49(2):423-431. doi: 10.1111/sltb.12440. Epub 2018 Feb 14.
PubMed 29444349Robinson DG, Schooler NR, Correll CU, John M, Kurian BT, Marcy P, Miller AL, Pipes R, Trivedi MH, Kane JM. Psychopharmacological Treatment in the RAISE-ETP Study: Outcomes of a Manual and Computer Decision Support System Based Intervention. Am J Psychiatry. 2018 Feb 1;175(2):169-179. doi: 10.1176/appi.ajp.2017.16080919. Epub 2017 Sep 15.
PubMed 28945118Rosenheck RA, Estroff SE, Sint K, Lin H, Mueser KT, Robinson DG, Schooler NR, Marcy P, Kane JM; RAISE-ETP Investigators. Incomes and Outcomes: Social Security Disability Benefits in First-Episode Psychosis. Am J Psychiatry. 2017 Sep 1;174(9):886-894. doi: 10.1176/appi.ajp.2017.16111273. Epub 2017 Apr 21.
PubMed 28427286Kane JM, Robinson DG, Schooler NR, Mueser KT, Penn DL, Rosenheck RA, Addington J, Brunette MF, Correll CU, Estroff SE, Marcy P, Robinson J, Meyer-Kalos PS, Gottlieb JD, Glynn SM, Lynde DW, Pipes R, Kurian BT, Miller AL, Azrin ST, Goldstein AB, Severe JB, Lin H, Sint KJ, John M, Heinssen RK. Comprehensive Versus Usual Community Care for First-Episode Psychosis: 2-Year Outcomes From the NIMH RAISE Early Treatment Program. Am J Psychiatry. 2016 Apr 1;173(4):362-72. doi: 10.1176/appi.ajp.2015.15050632. Epub 2015 Oct 20.
PubMed 26481174Kane JM, Schooler NR, Marcy P, Correll CU, Brunette MF, Mueser KT, Rosenheck RA, Addington J, Estroff SE, Robinson J, Penn DL, Robinson DG. The RAISE early treatment program for first-episode psychosis: background, rationale, and study design. J Clin Psychiatry. 2015 Mar;76(3):240-6. doi: 10.4088/JCP.14m09289.
PubMed 25830446
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery After an Initial Schizophrenia Episode (RAISE): RAISE Early Treatment Program
- ClinicalTrials.gov ID
- NCT01321177
- Acronym / sponsor ID
- RAISE ETP / HHSN271200900019C
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Brief Psychotic Disorder, Psychotic Disorder NOS
- Keywords
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Brief Psychotic Disorder, Psychotic Disorder NOS, First Episode
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- State University of New York - Downstate Medical Center, University of North Carolina, Chapel Hill, University of California, Los Angeles, Dartmouth-Hitchcock Medical Center, Research Foundation for Mental Hygiene, Inc., National Institute of Mental Health (NIMH)
- Study start
- Jul 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Posted 26 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine how services should be provided to reduce symptoms and improve life functioning for adolescents and adults who have been recently diagnosed with schizophrenia.
Detailed description
Schizophrenia is a major mental illness characterized by psychosis, negative symptoms (e.g., apathy, social withdrawal, anhedonia), and cognitive impairment. Depression and substance abuse commonly co-occur. These individuals have impaired functioning in the areas of work, school, parenting, self-care, independent living, interpersonal relationships, and leisure time. Among adult psychiatric disorders, schizophrenia is the most disabling, and its treatment accounts for a disproportionate share of mental health services.
This study is part of the National Institute of Mental Health's Recovery After an Initial Schizophrenia Episode (RAISE) Project. The RAISE Project seeks to fundamentally change the trajectory and prognosis of schizophrenia through coordinated and aggressive treatment in the earliest stages of illness. This study, the RAISE Early Treatment Program (ETP), is one of the two independent research studies that NIMH has funded to conduct the NIMH RAISE Project. ETP is being supported in whole or in part with Federal funds from the American Recovery and Reinvestment Act of 2009 and the NIMH, National Institutes of Health, Department of Health and Human Services.
The ETP study aims to compare two early treatment interventions for adolescents and adults experiencing a first episode of psychosis. The clinical centers have been randomly allocated to offer one of the two treatment programs. Both treatment interventions are designed to provide a person with treatment soon after he or she experiences the early signs of schizophrenia. Participants will be offered mental health services such as medication and psychosocial therapy. These strategies are all aimed at promoting symptom reduction and improving life functioning. Participation in this study will last between 2 and 3 years. All participants will first undergo an initial videoconference interview to confirm a diagnosis of schizophrenia, schizoaffective disorder, psychosis NOS, brief psychotic disorder, or schizophreniform disorder. Eligible participants will then be offered mental health services.
In addition to the mental health services, participants will participate in a series of research interviews. Participants will be interviewed every 3 months for the first 6 months and then every 6 months for up to 3 years. At the research visit, participants will complete an interview about their symptoms and general quality of life, complete questions about experiences with their illness, their vital signs will be measured, and a blood draw will be collected. At the initial, 12 and 24 month visits, participants will also complete a brief test that assesses skills such as memory, attention and problem solving. Participants will also have monthly telephone interviews about their illness and services that they have received.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Treatment | Experimental | Behavioral: Integrated TreatmentIntegrated program of treatments and services delivered by a coordinated team of providers. |
| Community Care | Active comparator | Behavioral: Community CareStandard mental health treatments and services offered at the local agency. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Confirmed SCID DSM-IV clinical diagnosis by trained remote clinical assessor of:
- Any duration of untreated psychosis
- Any ethnicity
- Ability to participate in research assessments in English
- Ability to provide fully informed consent (assent for those under age 18)
Key exclusion criteria (7 listed)
- Inability to understand what research participation entails or correctly answer the questions about research participation that are part of the Study Information Review and provide fully informed consent
- More than 4 months of prior cumulative treatment with antipsychotic medications
- Diagnosis of bipolar disorder, psychotic depression or substance-induced psychotic disorder
- Current psychotic disorder due to a general medical condition
- Current neurological disorders that would affect diagnosis or prognosis. These would include, but are not limited to seizure disorders, dementing or degenerative disorders, lesions or substantial congenital abnormalities. In most cases, disorders such as headache disorders would not require protocol exclusion
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 |
|---|---|---|
| Integrated TreatmentIntegrated program of treatments and services delivered by a coordinated team of providers that includes: * education about schizophrenia and its treatment for the participants and their family members * medication for symptoms and preventing relapse that uses a computerized decision support system * strategies for managing the illness and building personal resilience * help getting back to school or work using a supported employment/education model | Behavioural | Integrated Treatment |
| Community CareStandard mental health treatments and services offered at the local agency that may include : * medication for symptoms and preventing relapse * psychosocial therapy which may include a range of behavioral treatments and supportive services * Case management | Behavioural | Community Care |
Primary outcome
Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time
Time frame: Baseline, Month 6, month 12, month 18 and month 24
This scale measures psychosocial functioning and behavior in people with schizophrenia. The scale contains 21 items rated 0 (no or minimal functioning) to 6 (normal functioning). The results are reported as the total score with a range from 0 to 126. Higher scores indicate a better outcome.
3 secondary outcomes
Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score
Time frame: Measured at baseline, month 6, month 12, month 18, and month 24
Calgary Depression Scale
Time frame: Measured at baseline, month 6, month 12, month 18, and month 24
Service Use Rating Form (SURF)
Time frame: Measured at baseline and then monthly for months 1 through 24; reported as the monthly mean
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42768802McCarthy JM, Dow JF, Shepherd JM, Mueser KT. Longitudinal effects of lifetime trauma exposure and childhood sexual trauma by gender in individuals with first episode psychosis. Br J Clin Psychol. 2026 Sep 21. doi: 10.1111/bjc.70099. Online ahead of print.
- Derived from this study: PubMed 41920015Scanlon F, Mueser KT, Cather C. Correlates and Predictors of Criminal Legal Involvement in People With First-Episode Psychosis. J Clin Psychiatry. 2026 Mar 30;87(2):25m15991. doi: 10.4088/JCP.25m15991.
- Derived from this study: PubMed 37657279Mueser KT, Sussman RF, DeTore NR, Eberlin ES, McGurk SR. The impact of early intervention for first episode psychosis on cognitive functioning. Schizophr Res. 2023 Oct;260:132-139. doi: 10.1016/j.schres.2023.07.021. Epub 2023 Aug 30.
- Derived from this study: PubMed 36623822Hong SI, Bennett D, Rosenheck RA. Gender differences in outcomes of early intervention services for first episode psychosis. Early Interv Psychiatry. 2023 Jul;17(7):715-723. doi: 10.1111/eip.13367. Epub 2023 Jan 9.
- Derived from this study: PubMed 35026597Bornheimer LA, Cobia DJ, Li Verdugo J, Holzworth J, Smith MJ. Clinical insight and cognitive functioning as mediators in the relationships between symptoms of psychosis, depression, and suicide ideation in first-episode psychosis. J Psychiatr Res. 2022 Mar;147:85-93. doi: 10.1016/j.jpsychires.2022.01.006. Epub 2022 Jan 5.
- Derived from this study: PubMed 33493778Bornheimer LA, Wojtalik JA, Li J, Cobia D, Smith MJ. Suicidal ideation in first-episode psychosis: Considerations for depression, positive symptoms, clinical insight, and cognition. Schizophr Res. 2021 Feb;228:298-304. doi: 10.1016/j.schres.2020.12.025. Epub 2021 Jan 23.
- Derived from this study: PubMed 32052566Bornheimer LA, Tarrier N, Brinen AP, Li J, Dwyer M, Himle JA. Longitudinal predictors of stigma in first-episode psychosis: Mediating effects of depression. Early Interv Psychiatry. 2021 Apr;15(2):263-270. doi: 10.1111/eip.12935. Epub 2020 Feb 12.
- Derived from this study: PubMed 31084291Robinson DG, Schooler NR, Rosenheck RA, Lin H, Sint KJ, Marcy P, Kane JM. Predictors of Hospitalization of Individuals With First-Episode Psychosis: Data From a 2-Year Follow-Up of the RAISE-ETP. Psychiatr Serv. 2019 Jul 1;70(7):569-577. doi: 10.1176/appi.ps.201800511. Epub 2019 May 14.
- Derived from this study: PubMed 31026764Nuttall AK, Thakkar KN, Luo X, Mueser KT, Glynn SM, Achtyes ED, Kane JM. Longitudinal associations of family burden and patient quality of life in the context of first-episode schizophrenia in the RAISE-ETP study. Psychiatry Res. 2019 Jun;276:60-68. doi: 10.1016/j.psychres.2019.04.016. Epub 2019 Apr 16.
- Derived from this study: PubMed 30139553Mueser KT, Meyer-Kalos PS, Glynn SM, Lynde DW, Robinson DG, Gingerich S, Penn DL, Cather C, Gottlieb JD, Marcy P, Wiseman JL, Potretzke S, Brunette MF, Schooler NR, Addington J, Rosenheck RA, Estroff SE, Kane JM. Implementation and fidelity assessment of the NAVIGATE treatment program for first episode psychosis in a multi-site study. Schizophr Res. 2019 Feb;204:271-281. doi: 10.1016/j.schres.2018.08.015. Epub 2018 Aug 20.
- Derived from this study: PubMed 29444349Bornheimer LA. Suicidal Ideation in First-Episode Psychosis (FEP): Examination of Symptoms of Depression and Psychosis Among Individuals in an Early Phase of Treatment. Suicide Life Threat Behav. 2019 Apr;49(2):423-431. doi: 10.1111/sltb.12440. Epub 2018 Feb 14.
- Derived from this study: PubMed 28945118Robinson DG, Schooler NR, Correll CU, John M, Kurian BT, Marcy P, Miller AL, Pipes R, Trivedi MH, Kane JM. Psychopharmacological Treatment in the RAISE-ETP Study: Outcomes of a Manual and Computer Decision Support System Based Intervention. Am J Psychiatry. 2018 Feb 1;175(2):169-179. doi: 10.1176/appi.ajp.2017.16080919. Epub 2017 Sep 15.
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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.
John Kane, MD principal investigator
Feinstein Institute for Medical Research
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Treatment and Community Care in people with Schizophrenia and Schizoaffective Disorder, run by Northwell Health at 33 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 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?
Yes. Results are posted in the registry (first posted 26 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (time frame: Baseline, Month 6, month 12, month 18 and month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01321177, which also lists 16 linked publications.
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 26 Oct 2021.