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| ID | Type | Description | Link |
|---|---|---|---|
| HHSN271200900019C | Other Grant/Funding Number | NIMH |
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| Name | Class |
|---|---|
| State University of New York - Downstate Medical Center | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
| University of California, Los Angeles | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrated Treatment | Experimental | Integrated program of treatments and services delivered by a coordinated team of providers. |
|
| Community Care | Active Comparator | Standard mental health treatments and services offered at the local agency. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated Treatment | Behavioral | Integrated program of treatments and services delivered by a coordinated team of providers that includes:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Month 6, month 12, month 18 and month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 at baseline, month 6, month 12, month 18, and month 24 |
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Inclusion Criteria:
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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Kane, MD | Feinstein Institute for Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Fernando Mental Health Center | San Fernando | California | 91344 | United States | ||
| Santa ClaritaMental Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41920015 | Derived | Scanlon 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. | |
| 37657279 | Derived | Mueser 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Integrated Treatment | Integrated program of treatments and services delivered by a coordinated team of providers. Integrated Treatment: Integrated program of treatments and services delivered by a coordinated team of providers that includes:
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dartmouth-Hitchcock Medical Center |
| OTHER |
| Research Foundation for Mental Hygiene, Inc. | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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|
| Community Care | Behavioral | Standard mental health treatments and services offered at the local agency that may include :
|
|
| 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 at baseline, month 6, month 12, month 18, and month 24 |
| Service Use Rating Form (SURF) | Measures of treatment services used | Measured at baseline and then monthly for months 1 through 24; reported as the monthly mean |
| Santa Clarita |
| California |
| 91355 |
| United States |
| Mental Health Center of Denver | Denver | Colorado | 80220 | United States |
| United Services Inc. | Willimantic | Connecticut | 06226 | United States |
| Henderson Mental Health Center | Fort Lauderdale | Florida | 33319 | United States |
| Life management Center of Northwest Florida | Panama City | Florida | 32405 | United States |
| Central Fulton Community Mental Health Center | Atlanta | Georgia | 30303 | United States |
| Cobb County Community Services Board | Austell | Georgia | 30168 | United States |
| Park Center | Fort Wayne | Indiana | 46805 | United States |
| Community Mental Health Center, Inc. | Lawrenceburg | Indiana | 47025 | United States |
| Eyerly Ball | Des Moines | Iowa | 50309 | United States |
| Terrebonne Mental Health Center | Houma | Louisiana | 70360 | United States |
| River Parish Mental Health Center | Laplace | Louisiana | 70068 | United States |
| Catholic Social Services of Washtenaw County (CSSW) | Ann Arbor | Michigan | 48108 | United States |
| Touchstone Innovare | Grand Rapids | Michigan | 49503 | United States |
| Clinton-Eaton-Ingham Community Mental Health Authority | Lansing | Michigan | 48910 | United States |
| Human Development Center | Duluth | Minnesota | 55805 | United States |
| North Point Health and Wellness | Minneapolis | Minnesota | 55411 | United States |
| Pine Belt Mental Health Clinic | Hattiesburg | Mississippi | 39403 | United States |
| Burrell Behavioral Health | Columbia | Missouri | 65203 | United States |
| UMKC School of Pharmacy | Kansas City | Missouri | 64108 | United States |
| Burrell Behavioral Health | Springfield | Missouri | 65802 | United States |
| Community Alternatives | St Louis | Missouri | 63110 | United States |
| Community Mental Health Center of Lancaster County | Lincoln | Nebraska | 68502 | United States |
| The Mental Health Center of Greater Manchester | Manchester | New Hampshire | 03101 | United States |
| Greater Nashua Mental Health Center @ Community Council | Nashua | New Hampshire | 03060 | United States |
| Saint Clare's Hospital | Denville | New Jersey | 07834 | United States |
| University of New Mexico Department of Psychiatry UNM Health Sciences Center | Albuquerque | New Mexico | 87131 | United States |
| PeaceHealth Oregon/Lane County Behavioral Health Services | Eugene | Oregon | 97401 | United States |
| Lehigh Valley Hospital Mental Health Clinic | Allentown | Pennsylvania | 18104 | United States |
| South Shore Mental Health Center | Charlestown | Rhode Island | 02813 | United States |
| The Providence Center | Providence | Rhode Island | 02904 | United States |
| Howard Center | Burlington | Vermont | 05401 | United States |
| 36623822 | Derived | Hong 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. |
| 35026597 | Derived | Bornheimer 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. |
| 33493778 | Derived | Bornheimer 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. |
| 32052566 | Derived | Bornheimer 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. |
| 31084291 | Derived | Robinson 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. |
| 31026764 | Derived | Nuttall 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. |
| 30139553 | Derived | Mueser 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. |
| 29444349 | Derived | Bornheimer 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. |
| 28945118 | Derived | Robinson 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. |
| 28427286 | Derived | Rosenheck 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. |
| 26481174 | Derived | Kane 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. |
| 25830446 | Derived | Kane 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. |
| 25727536 | Derived | Robinson DG, Schooler NR, John M, Correll CU, Marcy P, Addington J, Brunette MF, Estroff SE, Mueser KT, Penn D, Robinson J, Rosenheck RA, Severe J, Goldstein A, Azrin S, Heinssen R, Kane JM. Prescription practices in the treatment of first-episode schizophrenia spectrum disorders: data from the national RAISE-ETP study. Am J Psychiatry. 2015 Mar 1;172(3):237-48. doi: 10.1176/appi.ajp.2014.13101355. Epub 2014 Dec 4. |
| FG001 | Community Care | Standard mental health treatments and services offered at the local agency. Community Care: Standard mental health treatments and services offered at the local agency that may include :
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Integrated Treatment | Integrated program of treatments and services delivered by a coordinated team of providers. Integrated Treatment: Integrated program of treatments and services delivered by a coordinated team of providers that includes:
|
| BG001 | Community Care | Standard mental health treatments and services offered at the local agency. Community Care: Standard mental health treatments and services offered at the local agency that may include :
|
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to treat population | Posted | Mean | Standard Error | score on a scale | Baseline, Month 6, month 12, month 18 and month 24 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Intent to treat | Posted | Mean | Standard Error | score on a scale | Measured at baseline, month 6, month 12, month 18, and month 24 |
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| Secondary | 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. | Posted | Mean | Standard Error | score on a scale | Measured at baseline, month 6, month 12, month 18, and month 24 |
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| Secondary | Service Use Rating Form (SURF) | Measures of treatment services used | Intent to Treat | Posted | Mean | Standard Deviation | Services received | Measured at baseline and then monthly for months 1 through 24; reported as the monthly mean |
|
Adverse events were not collected during this study. Serious Adverse Events (SAEs) were collected throughout the study period which is defined from the time that the informed consent document is signed until 30 days after the last study visit/session, up to 25 months. SAEs occurring more than 30 days after a participant is discontinued from the study will be reported only if the investigator believes that the event may have been caused by a protocol-related procedure.
Serious Adverse Events (SAEs) are defined as events that result in Death, inpatient hospitalization, a life-threatening experience, medically significant event not requiring hospitalization, persistent or significant disability/capacity, congenital anomaly/birth defect. Suicide attempts will be reported as SAEs, regardless of whether or not they result in hospitalization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Integrated Treatment | Integrated program of treatments and services delivered by a coordinated team of providers. Integrated Treatment: Integrated program of treatments and services delivered by a coordinated team of providers that includes:
| 1 | 223 | 71 | 223 | 0 | 0 |
| EG001 | Community Care | Standard mental health treatments and services offered at the local agency. Community Care: Standard mental health treatments and services offered at the local agency that may include :
| 0 | 181 | 66 | 181 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric Hospitalization/illness | Psychiatric disorders | Systematic Assessment |
| ||
| Medical hospitalization/illness | General disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Marcy | Northwell Health | 347-439-8035 | pmarcy@northwell.edu |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| 12 month |
|
| 18 months |
|
| 24 months |
|
|
|
| Units | Counts |
|---|---|
| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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