Multi-disciplinary Treatment for Patients Experiencing First Episode of Psychosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Maryland
New York State Office of Mental Health (OMH)
Maryland Department of Health and Mental Hygiene
Information provided by (Responsible Party):
Lisa Dixon, Research Foundation for Mental Hygiene
ClinicalTrials.gov Identifier:
NCT01216891
First received: October 4, 2010
Last updated: June 26, 2013
Last verified: April 2013
  Purpose

This study will assess the effectiveness of an experimental treatment intervention for adolescents and adults who have experienced their first episode of psychosis during the past two years.


Condition Intervention
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Delusional Disorder
Psychosis
Behavioral: Multi-element, team-oriented treatment

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Recovery After an Initial Schizophrenia Episode (RAISE): The RAISE Connection Program

Resource links provided by NLM:


Further study details as provided by Research Foundation for Mental Hygiene, Inc.:

Primary Outcome Measures:
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    This measures occupational functioning, social functioning and symptom severity.

  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    This assesses the level of severity of illness.

  • Calgary Depression Scale [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.

  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.

  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
    This assesses the level of severity of illness.

  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
    This assesses the level of severity of illness.

  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
    This assesses the level of severity of illness.

  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
    This assesses the level of severity of illness.

  • Calgary Depression Scale [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.

  • Calgary Depression Scale [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.

  • Calgary Depression Scale [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.

  • Calgary Depression Scale [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.

  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.

  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.

  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.

  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.


Estimated Enrollment: 65
Study Start Date: October 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Team-based treatment Behavioral: Multi-element, team-oriented treatment
Participants will receive treatment and services based on their needs coordinated by a small team that is led by a clinical coordinator. Services that are available to the participants include social skills training, medication treatment to address symptoms, education and employment advising, and substance use treatment.

Detailed Description:

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 Connection Program, is one of the two independent research studies that NIMH has funded to conduct the NIMH RAISE Project. The Connection Program 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 Connection Program aims to to assess the effectiveness of a Team-based intervention for individuals with a first psychotic episode, observing outcomes over time for our study participants. When tracking outcomes, the Connection Program will make comparisons with what is known about the natural history of untreated first episode of psychosis as well as usual care outcomes from other experimental studies.

This study is for people who have experienced symptoms such as hallucinations, unusual thoughts or beliefs, or disorganized thinking for the first time during the past two years. Without treatment, many people have a difficult time with these symptoms, which can be very upsetting and also make it hard to socialize, study, or work.

People have different wishes and needs, and it is not clear what combination of treatments and services is best for any one person. There are many possible treatments and services, such as medications, talk therapy, case management, and school and job counseling. This study will adapt and evaluate the impact of a comprehensive and integrated treatment intervention for first episode psychosis to be delivered in real-world practice settings to promote symptomatic recovery, minimize disability, and maximize social, academic, and vocational functioning.

Participation in this study will last up to 2 years. At the baseline visit, participants will be enrolled to receive the experimental intervention. During the study period, participants will take part in research interviews every three to six months for a total of 6 interviews. Each of these research interviews will take 1.5 to 3 hours to complete. Assessments of participants' health condition, overall function and illness severity, employment status, academic performance, and social functioning will be conducted during these research interviews. In addition to assessing functioning and illness severity, this study will also address substance abuse and utilization of healthcare services. Participants will also be measured for their height, weight and waist circumference.

  Eligibility

Ages Eligible for Study:   15 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age range: 15-35 years old (16-35 years old in New York)
  • Diagnosis of schizophrenia, schizoaffective and schizophreniform disorder, delusional disorder, or psychosis not otherwise specified (NOS)
  • Duration of psychotic symptoms > 1 week and < 2 years
  • Ability to provide informed consent
  • Ability to speak and understand English
  • Anticipated availability to participate in the intervention for at least 1 year

Exclusion Criteria:

  • Medical conditions which impair function independent of psychosis
  • Other diagnoses associated with psychosis:
  • Substance-induced psychotic disorder
  • Psychotic affective disorder (major depressive or manic episode with psychotic features)
  • Psychotic disorder due to a general medication condition
  • Mental retardation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216891

Locations
United States, Maryland
University of Maryland Medical Center, Carruthers Clinic
Baltimore, Maryland, United States, 21230
United States, New York
Washington Heights Community Service Clinic
New York, New York, United States, 10032
Sponsors and Collaborators
Research Foundation for Mental Hygiene, Inc.
University of Maryland
New York State Office of Mental Health (OMH)
Maryland Department of Health and Mental Hygiene
Investigators
Principal Investigator: Lisa Dixon, MD Columbia University
Principal Investigator: Melanie Bennett, PhD University of Maryland
  More Information

Additional Information:
No publications provided

Responsible Party: Lisa Dixon, Director Center for Practice Innovations, Research Foundation for Mental Hygiene
ClinicalTrials.gov Identifier: NCT01216891     History of Changes
Other Study ID Numbers: RAISE Connection, HHSN271200900020C
Study First Received: October 4, 2010
Last Updated: June 26, 2013
Health Authority: United States: Federal Government

Keywords provided by Research Foundation for Mental Hygiene, Inc.:
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Delusional Disorder
Psychosis
First episode

Additional relevant MeSH terms:
Schizophrenia, Paranoid
Delusions
Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 18, 2014