Clinical trial NCT01321177: An Integrated Program for the Treatment of First Episode of Psychosis
Official title: Recovery After an Initial Schizophrenia Episode (RAISE): RAISE Early Treatment Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: State University of New York - Downstate Medical Center
name: University of North Carolina, Chapel Hill
name: University of California, Los Angeles
name: Dartmouth-Hitchcock Medical Center
name: Research Foundation for Mental Hygiene, Inc.
name: National Institute of Mental Health (NIMH)
First posted: 2011-03-23
Enrollment: 404
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time
timeFrame: Baseline, Month 6, month 12, month 18 and month 24
Secondary outcomes:
measure: Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score
timeFrame: Measured at baseline, month 6, month 12, month 18, and month 24
measure: Calgary Depression Scale
timeFrame: Measured at baseline, month 6, month 12, month 18, and month 24
measure: Service Use Rating Form (SURF)
timeFrame: Measured at baseline and then monthly for months 1 through 24; reported as the monthly mean
Other outcomes:
Locations:
city: San Fernando
country: United States
facility: San Fernando Mental Health Center
state: California
city: Santa Clarita
country: United States
facility: Santa ClaritaMental Health Center
state: California
city: Denver
country: United States
facility: Mental Health Center of Denver
state: Colorado
city: Willimantic
country: United States
facility: United Services Inc.
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Henderson Mental Health Center
state: Florida
city: Panama City
country: United States
facility: Life management Center of Northwest Florida
state: Florida
city: Atlanta
country: United States
facility: Central Fulton Community Mental Health Center
state: Georgia
city: Austell
country: United States
facility: Cobb County Community Services Board
state: Georgia
city: Fort Wayne
country: United States
facility: Park Center
state: Indiana
city: Lawrenceburg
country: United States
facility: Community Mental Health Center, Inc.
state: Indiana
city: Des Moines
country: United States
facility: Eyerly Ball
state: Iowa
city: Houma
country: United States
facility: Terrebonne Mental Health Center
state: Louisiana
city: Laplace
country: United States
facility: River Parish Mental Health Center
state: Louisiana
city: Ann Arbor
country: United States
facility: Catholic Social Services of Washtenaw County (CSSW)
state: Michigan
city: Grand Rapids
country: United States
facility: Touchstone Innovare
state: Michigan
city: Lansing
country: United States
facility: Clinton-Eaton-Ingham Community Mental Health Authority
state: Michigan
city: Duluth
country: United States
facility: Human Development Center
state: Minnesota
city: Minneapolis
country: United States
facility: North Point Health and Wellness
state: Minnesota
city: Hattiesburg
country: United States
facility: Pine Belt Mental Health Clinic
state: Mississippi
city: Columbia
country: United States
facility: Burrell Behavioral Health
state: Missouri
city: Kansas City
country: United States
facility: UMKC School of Pharmacy
state: Missouri
city: Saint Louis
country: United States
facility: Community Alternatives
state: Missouri
city: Springfield
country: United States
facility: Burrell Behavioral Health
state: Missouri
city: Lincoln
country: United States
facility: Community Mental Health Center of Lancaster County
state: Nebraska
city: Manchester
country: United States
facility: The Mental Health Center of Greater Manchester
state: New Hampshire
city: Nashua
country: United States
facility: Greater Nashua Mental Health Center @ Community Council
state: New Hampshire
city: Denville
country: United States
facility: Saint Clare's Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Department of Psychiatry UNM Health Sciences Center
state: New Mexico
city: Eugene
country: United States
facility: PeaceHealth Oregon/Lane County Behavioral Health Services
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital Mental Health Clinic
state: Pennsylvania
city: Charlestown
country: United States
facility: South Shore Mental Health Center
state: Rhode Island
city: Providence
country: United States
facility: The Providence Center
state: Rhode Island
city: Burlington
country: United States
facility: Howard Center
state: Vermont
Study officials:
affiliation: Feinstein Institute for Medical Research
name: John Kane, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.