NCT01216891

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

4.3 years

First QC Date

October 4, 2010

Last Update Submit

November 2, 2016

Conditions

Keywords

SchizophreniaSchizoaffective DisorderSchizophreniform DisorderDelusional DisorderPsychosisFirst episode

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

    This assessment gathers information on help-seeking events and participant recommendations.

    Measured at baseline

Secondary Outcomes (15)

  • The Clinical Global Impression (CGI) - Severity scale

    Measured at baseline

  • Calgary Depression Scale

    Measured at baseline

  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS)

    Measured at baseline

  • The Clinical Global Impression (CGI) - Severity scale

    Measured at Month 6

  • The Clinical Global Impression (CGI) - Severity scale

    Measured at Month 12

  • +10 more secondary outcomes

Study Arms (1)

Team-based treatment

EXPERIMENTAL
Behavioral: Multi-element, team-oriented treatment

Interventions

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.

Team-based treatment

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Maryland Medical Center, Carruthers Clinic

Baltimore, Maryland, 21230, United States

Location

Washington Heights Community Service Clinic

New York, New York, 10032, United States

Location

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersSchizophrenia, Paranoid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Lisa Dixon, MD

    Columbia University

    PRINCIPAL INVESTIGATOR
  • Melanie Bennett, PhD

    University of Maryland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Center for Practice Innovations

Study Record Dates

First Submitted

October 4, 2010

First Posted

October 7, 2010

Study Start

October 1, 2010

Primary Completion

January 1, 2015

Study Completion

August 1, 2016

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations