Multi-disciplinary Treatment for Patients Experiencing First Episode of Psychosis

Sponsor

Research Foundation for Mental Hygiene, Inc. (Other)

Overall Status

Completed

CT.gov ID

NCT01216891

Collaborator

National Institute of Mental Health (NIMH) (NIH), University of Maryland (Other), New York State Office of Mental Health (OMH) (Other), Maryland Department of Health and Mental Hygiene (Other)

Enrollment

Locations

Arm

Duration (Months)

32.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Delusional Disorder Psychosis	Behavioral: Multi-element, team-oriented treatment	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [Measured at baseline]
This measures occupational functioning, social functioning and symptom severity.
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [Measured at Month 6]
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [Measured at Month 12]
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [Measured at Month 18]
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [Measured at Month 24]
Pathways to Care Qualitative Interview [Measured at baseline]
This assessment gathers information on help-seeking events and participant recommendations.

Secondary Outcome Measures

The Clinical Global Impression (CGI) - Severity scale [Measured at baseline]
This assesses the level of severity of illness.
Calgary Depression Scale [Measured at baseline]
This assesses depression in people with schizophrenia.
Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [Measured at baseline]
This measures the presence and severity of symptoms of schizophrenia.
The Clinical Global Impression (CGI) - Severity scale [Measured at Month 6]
This assesses the level of severity of illness.
The Clinical Global Impression (CGI) - Severity scale [Measured at Month 12]
This assesses the level of severity of illness.
The Clinical Global Impression (CGI) - Severity scale [Measured at Month 18]
This assesses the level of severity of illness.
The Clinical Global Impression (CGI) - Severity scale [Measured at Month 24]
This assesses the level of severity of illness.
Calgary Depression Scale [Measured at Month 6]
This assesses depression in people with schizophrenia.
Calgary Depression Scale [Measured at Month 12]
This assesses depression in people with schizophrenia.
Calgary Depression Scale [Measured at Month 18]
This assesses depression in people with schizophrenia.
Calgary Depression Scale [Measured at Month 24]
This assesses depression in people with schizophrenia.
Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [Measured at Month 6]
This measures the presence and severity of symptoms of schizophrenia.
Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [Measured at Month 12]
This measures the presence and severity of symptoms of schizophrenia.
Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [Measured at Month 18]
This measures the presence and severity of symptoms of schizophrenia.
Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [Measured at Month 24]
This measures the presence and severity of symptoms of schizophrenia.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 35 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland Medical Center, Carruthers Clinic	Baltimore	Maryland	United States	21230
2	Washington Heights Community Service Clinic	New York	New York	United States	10032