An Integrated Program for the Treatment of First Episode of Psychosis (RAISE ETP)

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Psychotic Disorder NOS; Brief Psychotic Disorder
• Intervention / Treatment: Behavioral: Integrated Treatment; Behavioral: Community Care

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 Type: Interventional
• Enrollment (Actual): 404
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Fernando, California, United States, 91344
      • San Fernando Mental Health Center
    • Santa Clarita, California, United States, 91355
      • Santa ClaritaMental Health Center
  • Colorado
    • Denver, Colorado, United States, 80220
      • Mental Health Center of Denver
  • Connecticut
    • Willimantic, Connecticut, United States, 06226
      • United Services Inc.
  • Florida
    • Fort Lauderdale, Florida, United States, 33319
      • Henderson Mental Health Center
    • Panama City, Florida, United States, 32405
      • Life management Center of Northwest Florida
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Central Fulton Community Mental Health Center
    • Austell, Georgia, United States, 30168
      • Cobb County Community Services Board
  • Indiana
    • Fort Wayne, Indiana, United States, 46805
      • Park Center
    • Lawrenceburg, Indiana, United States, 47025
      • Community Mental Health Center, Inc.
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • Eyerly Ball
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Terrebonne Mental Health Center
    • Laplace, Louisiana, United States, 70068
      • River Parish Mental Health Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • Catholic Social Services of Washtenaw County (CSSW)
    • Grand Rapids, Michigan, United States, 49503
      • Touchstone Innovare
    • Lansing, Michigan, United States, 48910
      • Clinton-Eaton-Ingham Community Mental Health Authority
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Human Development Center
    • Minneapolis, Minnesota, United States, 55411
      • North Point Health and Wellness
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39403
      • Pine Belt Mental Health Clinic
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Burrell Behavioral Health
    • Kansas City, Missouri, United States, 64108
      • UMKC School of Pharmacy
    • Saint Louis, Missouri, United States, 63110
      • Community Alternatives
    • Springfield, Missouri, United States, 65802
      • Burrell Behavioral Health
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Community Mental Health Center of Lancaster County
  • New Hampshire
    • Manchester, New Hampshire, United States, 03101
      • The Mental Health Center of Greater Manchester
    • Nashua, New Hampshire, United States, 03060
      • Greater Nashua Mental Health Center @ Community Council
  • New Jersey
    • Denville, New Jersey, United States, 07834
      • Saint Clare's Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Department of Psychiatry UNM Health Sciences Center
  • Oregon
    • Eugene, Oregon, United States, 97401
      • PeaceHealth Oregon/Lane County Behavioral Health Services
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Valley Hospital Mental Health Clinic
  • Rhode Island
    • Charlestown, Rhode Island, United States, 02813
      • South Shore Mental Health Center
    • Providence, Rhode Island, United States, 02904
      • The Providence Center
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Howard Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrated Treatment; Integrated program of treatments and services delivered by a coordinated team of providers.	Behavioral: 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
Active Comparator: Community Care; Standard mental health treatments and services offered at the local agency.	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: National Institute of Mental Health (NIMH); University of California, Los Angeles; Dartmouth-Hitchcock Medical Center; University of North Carolina, Chapel Hill; Research Foundation for Mental Hygiene, Inc.; State University of New York - Downstate Medical Center
• Investigators: Principal Investigator: John Kane, MD, Feinstein Institute for Medical Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: January 27, 2011
• First Submitted That Met QC Criteria: March 21, 2011
• First Posted (Estimate): March 23, 2011

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 24, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Brief Psychotic Disorder; Psychotic Disorder NOS; First Episode
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: HHSN271200900019C (Other Grant/Funding Number: NIMH)