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Multi-disciplinary Treatment for Patients Experiencing First Episode of Psychosis

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-element, team-oriented treatment
Sponsored by
Research Foundation for Mental Hygiene, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder, Psychosis, First episode

Eligibility Criteria

15 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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
  • RAISE-DUP: participants must have been enrolled in the RAISE study

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

Sites / Locations

  • University of Maryland Medical Center, Carruthers Clinic
  • Washington Heights Community Service Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Team-based treatment

Arm Description

Outcomes

Primary Outcome Measures

The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
This measures occupational functioning, social functioning and symptom severity.
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
Pathways to Care Qualitative Interview
This assessment gathers information on help-seeking events and participant recommendations.

Secondary Outcome Measures

The Clinical Global Impression (CGI) - Severity scale
This assesses the level of severity of illness.
Calgary Depression Scale
This assesses depression in people with schizophrenia.
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
This measures the presence and severity of symptoms of schizophrenia.
The Clinical Global Impression (CGI) - Severity scale
This assesses the level of severity of illness.
The Clinical Global Impression (CGI) - Severity scale
This assesses the level of severity of illness.
The Clinical Global Impression (CGI) - Severity scale
This assesses the level of severity of illness.
The Clinical Global Impression (CGI) - Severity scale
This assesses the level of severity of illness.
Calgary Depression Scale
This assesses depression in people with schizophrenia.
Calgary Depression Scale
This assesses depression in people with schizophrenia.
Calgary Depression Scale
This assesses depression in people with schizophrenia.
Calgary Depression Scale
This assesses depression in people with schizophrenia.
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
This measures the presence and severity of symptoms of schizophrenia.
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
This measures the presence and severity of symptoms of schizophrenia.
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
This measures the presence and severity of symptoms of schizophrenia.
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
This measures the presence and severity of symptoms of schizophrenia.

Full Information

First Posted
October 4, 2010
Last Updated
November 2, 2016
Sponsor
Research Foundation for Mental Hygiene, Inc.
Collaborators
National Institute of Mental Health (NIMH), University of Maryland, New York State Office of Mental Health (OMH), Maryland Department of Health and Mental Hygiene
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1. Study Identification

Unique Protocol Identification Number
NCT01216891
Brief Title
Multi-disciplinary Treatment for Patients Experiencing First Episode of Psychosis
Official Title
Recovery After an Initial Schizophrenia Episode (RAISE): The RAISE Connection Program Duration of Untreated Psychosis (DUP)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Foundation for Mental Hygiene, Inc.
Collaborators
National Institute of Mental Health (NIMH), University of Maryland, New York State Office of Mental Health (OMH), Maryland Department of Health and Mental Hygiene

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. The DUP sub-study will collect pathways to care information that will be used to inform the development and pilot testing of strategies that aim to reduce DUP among individuals experiencing a first episode of psychosis.
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. This portion of the study concluded in December 2013. The RAISE-DUP contract modification seeks additional information on the referral pathways that resulted in enrollment in the RAISE Connection Program from individuals who participated in RAISE Connection Program services and their family members. Information gathered through qualitative research interviews will be used to inform the development and pilot testing of outreach, education, and engagement intervention strategies, to serve the larger goal of reducing the duration of untreated psychosis among individuals experiencing a first episode of psychosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder, Psychosis
Keywords
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder, Psychosis, First episode

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Team-based treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Multi-element, team-oriented treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
Description
This measures occupational functioning, social functioning and symptom severity.
Time Frame
Measured at baseline
Title
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
Time Frame
Measured at Month 6
Title
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
Time Frame
Measured at Month 12
Title
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
Time Frame
Measured at Month 18
Title
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
Time Frame
Measured at Month 24
Title
Pathways to Care Qualitative Interview
Description
This assessment gathers information on help-seeking events and participant recommendations.
Time Frame
Measured at baseline
Secondary Outcome Measure Information:
Title
The Clinical Global Impression (CGI) - Severity scale
Description
This assesses the level of severity of illness.
Time Frame
Measured at baseline
Title
Calgary Depression Scale
Description
This assesses depression in people with schizophrenia.
Time Frame
Measured at baseline
Title
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Description
This measures the presence and severity of symptoms of schizophrenia.
Time Frame
Measured at baseline
Title
The Clinical Global Impression (CGI) - Severity scale
Description
This assesses the level of severity of illness.
Time Frame
Measured at Month 6
Title
The Clinical Global Impression (CGI) - Severity scale
Description
This assesses the level of severity of illness.
Time Frame
Measured at Month 12
Title
The Clinical Global Impression (CGI) - Severity scale
Description
This assesses the level of severity of illness.
Time Frame
Measured at Month 18
Title
The Clinical Global Impression (CGI) - Severity scale
Description
This assesses the level of severity of illness.
Time Frame
Measured at Month 24
Title
Calgary Depression Scale
Description
This assesses depression in people with schizophrenia.
Time Frame
Measured at Month 6
Title
Calgary Depression Scale
Description
This assesses depression in people with schizophrenia.
Time Frame
Measured at Month 12
Title
Calgary Depression Scale
Description
This assesses depression in people with schizophrenia.
Time Frame
Measured at Month 18
Title
Calgary Depression Scale
Description
This assesses depression in people with schizophrenia.
Time Frame
Measured at Month 24
Title
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Description
This measures the presence and severity of symptoms of schizophrenia.
Time Frame
Measured at Month 6
Title
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Description
This measures the presence and severity of symptoms of schizophrenia.
Time Frame
Measured at Month 12
Title
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Description
This measures the presence and severity of symptoms of schizophrenia.
Time Frame
Measured at Month 18
Title
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Description
This measures the presence and severity of symptoms of schizophrenia.
Time Frame
Measured at Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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 RAISE-DUP: participants must have been enrolled in the RAISE study 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Dixon, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Melanie Bennett, PhD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Medical Center, Carruthers Clinic
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21230
Country
United States
Facility Name
Washington Heights Community Service Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.nimh.nih.gov/RAISE
Description
Related Info

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Multi-disciplinary Treatment for Patients Experiencing First Episode of Psychosis

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