Multi-disciplinary Treatment for Patients Experiencing First Episode of Psychosis

Schizophrenia Clinical Trial

Official title:

Recovery After an Initial Schizophrenia Episode (RAISE): The RAISE Connection Program Duration of Untreated Psychosis (DUP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216891
• Other study ID #: RAISE Connection
• Secondary ID: HHSN271200900020
• Status: Completed
• Phase: N/A
• First received: October 4, 2010
• Last updated: November 2, 2016
• Start date: October 2010
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: Research Foundation for Mental Hygiene, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 35 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delusional Disorder
• Delusions
• Disease
• Mental Disorders
• Psychosis
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophrenia, Paranoid
• Schizophreniform Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of Maryland Medical Center, Carruthers Clinic	Baltimore	Maryland
United States	Washington Heights Community Service Clinic	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Research Foundation for Mental Hygiene, Inc.	Maryland Department of Health and Mental Hygiene, National Institute of Mental Health (NIMH), New York State Office of Mental Health (OMH), University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)	This measures occupational functioning, social functioning and symptom severity.	Measured at baseline	No
Primary	The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)		Measured at Month 6	No
Primary	The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)		Measured at Month 12	No
Primary	The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)		Measured at Month 18	No
Primary	The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)		Measured at Month 24	No
Primary	Pathways to Care Qualitative Interview	This assessment gathers information on help-seeking events and participant recommendations.	Measured at baseline	No
Secondary	The Clinical Global Impression (CGI) - Severity scale	This assesses the level of severity of illness.	Measured at baseline	No
Secondary	Calgary Depression Scale	This assesses depression in people with schizophrenia.	Measured at baseline	No
Secondary	Positive and Negative Syndrome Scale for Schizophrenia (PANSS)	This measures the presence and severity of symptoms of schizophrenia.	Measured at baseline	No
Secondary	The Clinical Global Impression (CGI) - Severity scale	This assesses the level of severity of illness.	Measured at Month 6	No
Secondary	The Clinical Global Impression (CGI) - Severity scale	This assesses the level of severity of illness.	Measured at Month 12	No
Secondary	The Clinical Global Impression (CGI) - Severity scale	This assesses the level of severity of illness.	Measured at Month 18	No
Secondary	The Clinical Global Impression (CGI) - Severity scale	This assesses the level of severity of illness.	Measured at Month 24	No
Secondary	Calgary Depression Scale	This assesses depression in people with schizophrenia.	Measured at Month 6	No
Secondary	Calgary Depression Scale	This assesses depression in people with schizophrenia.	Measured at Month 12	No
Secondary	Calgary Depression Scale	This assesses depression in people with schizophrenia.	Measured at Month 18	No
Secondary	Calgary Depression Scale	This assesses depression in people with schizophrenia.	Measured at Month 24	No
Secondary	Positive and Negative Syndrome Scale for Schizophrenia (PANSS)	This measures the presence and severity of symptoms of schizophrenia.	Measured at Month 6	No
Secondary	Positive and Negative Syndrome Scale for Schizophrenia (PANSS)	This measures the presence and severity of symptoms of schizophrenia.	Measured at Month 12	No
Secondary	Positive and Negative Syndrome Scale for Schizophrenia (PANSS)	This measures the presence and severity of symptoms of schizophrenia.	Measured at Month 18	No
Secondary	Positive and Negative Syndrome Scale for Schizophrenia (PANSS)	This measures the presence and severity of symptoms of schizophrenia.	Measured at Month 24	No

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