An Integrated Program for the Treatment of First Episode of Psychosis
NCT ID: NCT01321177
Last Updated: 2021-10-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
404 participants
INTERVENTIONAL
2010-07-31
2017-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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:
* 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 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 :
* medication for symptoms and preventing relapse
* psychosocial therapy which may include a range of behavioral treatments and supportive services
* Case management
Interventions
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Integrated Treatment
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 Care
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
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
15 Years
40 Years
ALL
No
Sponsors
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State University of New York - Downstate Medical Center
OTHER
University of North Carolina, Chapel Hill
OTHER
University of California, Los Angeles
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
Research Foundation for Mental Hygiene, Inc.
OTHER
National Institute of Mental Health (NIMH)
NIH
Northwell Health
OTHER
Responsible Party
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John Kane
Chairman, Psychiatry
Principal Investigators
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John Kane, MD
Role: PRINCIPAL_INVESTIGATOR
Feinstein Institute for Medical Research
Locations
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San Fernando Mental Health Center
San Fernando, California, United States
Santa ClaritaMental Health Center
Santa Clarita, California, United States
Mental Health Center of Denver
Denver, Colorado, United States
United Services Inc.
Willimantic, Connecticut, United States
Henderson Mental Health Center
Fort Lauderdale, Florida, United States
Life management Center of Northwest Florida
Panama City, Florida, United States
Central Fulton Community Mental Health Center
Atlanta, Georgia, United States
Cobb County Community Services Board
Austell, Georgia, United States
Park Center
Fort Wayne, Indiana, United States
Community Mental Health Center, Inc.
Lawrenceburg, Indiana, United States
Eyerly Ball
Des Moines, Iowa, United States
Terrebonne Mental Health Center
Houma, Louisiana, United States
River Parish Mental Health Center
Laplace, Louisiana, United States
Catholic Social Services of Washtenaw County (CSSW)
Ann Arbor, Michigan, United States
Touchstone Innovare
Grand Rapids, Michigan, United States
Clinton-Eaton-Ingham Community Mental Health Authority
Lansing, Michigan, United States
Human Development Center
Duluth, Minnesota, United States
North Point Health and Wellness
Minneapolis, Minnesota, United States
Pine Belt Mental Health Clinic
Hattiesburg, Mississippi, United States
Burrell Behavioral Health
Columbia, Missouri, United States
UMKC School of Pharmacy
Kansas City, Missouri, United States
Burrell Behavioral Health
Springfield, Missouri, United States
Community Alternatives
St Louis, Missouri, United States
Community Mental Health Center of Lancaster County
Lincoln, Nebraska, United States
The Mental Health Center of Greater Manchester
Manchester, New Hampshire, United States
Greater Nashua Mental Health Center @ Community Council
Nashua, New Hampshire, United States
Saint Clare's Hospital
Denville, New Jersey, United States
University of New Mexico Department of Psychiatry UNM Health Sciences Center
Albuquerque, New Mexico, United States
PeaceHealth Oregon/Lane County Behavioral Health Services
Eugene, Oregon, United States
Lehigh Valley Hospital Mental Health Clinic
Allentown, Pennsylvania, United States
South Shore Mental Health Center
Charlestown, Rhode Island, United States
The Providence Center
Providence, Rhode Island, United States
Howard Center
Burlington, Vermont, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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HHSN271200900019C
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HHSN271200900019C
Identifier Type: -
Identifier Source: org_study_id