An Integrated Program for the Treatment of First Episode of Psychosis

NCT01321177 | Completed Results DMC

• 1 other identifier: HHSN271200900019C
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 33

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score

  Measured at baseline, month 6, month 12, month 18, and month 24

• Calgary Depression Scale

  Measured at baseline, month 6, month 12, month 18, and month 24

• Service Use Rating Form (SURF)

  Measured at baseline and then monthly for months 1 through 24; reported as the monthly mean

Study Arms (2)

Integrated Treatment

EXPERIMENTAL

Integrated program of treatments and services delivered by a coordinated team of providers.

Behavioral: Integrated Treatment

Community Care

ACTIVE COMPARATOR

Standard mental health treatments and services offered at the local agency.

Behavioral: Community Care

Interventions

Integrated Treatment BEHAVIORAL

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

Integrated Treatment

Community Care BEHAVIORAL

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

Community Care

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Northwell Health: lead
• State University of New York - Downstate Medical Center: collaborator
• University of North Carolina, Chapel Hill: collaborator
• University of California, Los Angeles: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• Research Foundation for Mental Hygiene, Inc.: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (33)

San Fernando Mental Health Center

San Fernando, California, 91344, United States

Location

Santa ClaritaMental Health Center

Santa Clarita, California, 91355, United States

Location

Mental Health Center of Denver

Denver, Colorado, 80220, United States

Location

United Services Inc.

Willimantic, Connecticut, 06226, United States

Location

Henderson Mental Health Center

Fort Lauderdale, Florida, 33319, United States

Location

Life management Center of Northwest Florida

Panama City, Florida, 32405, United States

Location

Central Fulton Community Mental Health Center

Atlanta, Georgia, 30303, United States

Location

Cobb County Community Services Board

Austell, Georgia, 30168, United States

Location

Park Center

Fort Wayne, Indiana, 46805, United States

Location

Community Mental Health Center, Inc.

Lawrenceburg, Indiana, 47025, United States

Location

Eyerly Ball

Des Moines, Iowa, 50309, United States

Location

Terrebonne Mental Health Center

Houma, Louisiana, 70360, United States

Location

River Parish Mental Health Center

Laplace, Louisiana, 70068, United States

Location

Catholic Social Services of Washtenaw County (CSSW)

Ann Arbor, Michigan, 48108, United States

Location

Touchstone Innovare

Grand Rapids, Michigan, 49503, United States

Location

Clinton-Eaton-Ingham Community Mental Health Authority

Lansing, Michigan, 48910, United States

Location

Human Development Center

Duluth, Minnesota, 55805, United States

Location

North Point Health and Wellness

Minneapolis, Minnesota, 55411, United States

Location

Pine Belt Mental Health Clinic

Hattiesburg, Mississippi, 39403, United States

Location

Burrell Behavioral Health

Columbia, Missouri, 65203, United States

Location

UMKC School of Pharmacy

Kansas City, Missouri, 64108, United States

Location

Burrell Behavioral Health

Springfield, Missouri, 65802, United States

Location

Community Alternatives

St Louis, Missouri, 63110, United States

Location

Community Mental Health Center of Lancaster County

Lincoln, Nebraska, 68502, United States

Location

The Mental Health Center of Greater Manchester

Manchester, New Hampshire, 03101, United States

Location

Greater Nashua Mental Health Center @ Community Council

Nashua, New Hampshire, 03060, United States

Location

Saint Clare's Hospital

Denville, New Jersey, 07834, United States

Location

University of New Mexico Department of Psychiatry UNM Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

PeaceHealth Oregon/Lane County Behavioral Health Services

Eugene, Oregon, 97401, United States

Location

Lehigh Valley Hospital Mental Health Clinic

Allentown, Pennsylvania, 18104, United States

Location

South Shore Mental Health Center

Charlestown, Rhode Island, 02813, United States

Location

The Providence Center

Providence, Rhode Island, 02904, United States

Location

Howard Center

Burlington, Vermont, 05401, United States

Location

Related Publications (14)

• 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.

  PMID: 37657279 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.

  PMID: 36623822 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.

  PMID: 35026597 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.

  PMID: 33493778 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.

  PMID: 32052566 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.

  PMID: 31084291 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.

  PMID: 31026764 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.

  PMID: 30139553 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.

  PMID: 29444349 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.

  PMID: 28945118 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.

  PMID: 28427286 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.

  PMID: 26481174 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.

  PMID: 25830446 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.

  PMID: 25727536 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Results Point of Contact

• Title: Patricia Marcy
• Organization: Northwell Health

pmarcy@northwell.edu

347-439-8035

Study Officials

• John Kane, MD

  Feinstein Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Psychiatry

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: March 23, 2011
• Study Start: July 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2017
• Last Updated: October 26, 2021
• Results First Posted: October 26, 2021

Record last verified: 2021-10

Locations

US (33)