Psychosis: Early Detection, Intervention and Prevention (EDIP)

This study has been completed.
Sponsor:
Collaborators:
Columbia University
Harvard University
University of California, Irvine
Information provided by (Responsible Party):
William McFarlane, Maine Medical Center
ClinicalTrials.gov Identifier:
NCT01597141
First received: May 9, 2012
Last updated: January 7, 2016
Last verified: January 2016

May 9, 2012
January 7, 2016
May 2003
September 2014   (final data collection date for primary outcome measure)
Onset of Psychosis [ Time Frame: From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months ] [ Designated as safety issue: No ]
Onset of psychosis is defined as an event--a new psychotic episode with loss of insight, meeting a score criterion of 6 for one month on the Scale of the Prodromal Syndrome (SOPS), in which full psychosis is defined as havng one score or 6, on a scale of 0 to 6, with 0 representing no psychotic symptoms, and 6 representing full psychosis on any of 5 dimensions of psychosis. The assessemnt is based on the Structrued Interview for the Prodromal Syndrome (SIPS), w widely used instrument for assessing risk of psychosis in adolescents and young adults.
Onset of Psychosis [ Time Frame: From Baseline to 60 months ] [ Designated as safety issue: No ]
Onset of psychosis is defined as an event--a new psychotic episode with loss of insight, meeting a score criterion of 6 on the scale assessing prodromal psychotic symptoms.
Complete list of historical versions of study NCT01597141 on ClinicalTrials.gov Archive Site
Functioning [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Global Assessment of Functioning scale (GAF) at 24 months to assess functioning in symptom, role and social relationships. Global Assessment of Functioning is a widely used scale based on a Likert-keyed score assigned by an interviewer or clinician, based on a scale of 0-100, with 100 being the highest level of functioning.
  • Functioning [ Time Frame: Baseline, 6, 12, 18 24 and 60 months ] [ Designated as safety issue: No ]
    Change in functioning in role and social relationships, assessed by several measures, including Global Assessment of Functioining and the Social Adjustment Scale.
  • Incidence of first hospitalizations for a psychotic episode [ Time Frame: 1993-2007 ] [ Designated as safety issue: No ]
    Incidence is compared before and after initiation of the study in May of 2003 to assess effect of the program on community incidence of psychotic disorders.
Not Provided
Not Provided
 
Psychosis: Early Detection, Intervention and Prevention
Psychosis: Early Detection, Intervention and Prevention
The primary aim of this application is to conduct a randomized, controlled clinical trial of a specialized mental health service delivery system specifically developed for prodromal psychotic disorders. The intervention is Family-aided Assertive Community Treatment (FACT). The goal of the treatment is prevention of psychosis and disability. This study will assess experimentally the clinical effectiveness of this new type of mental health service. Other domains of outcome include cognitive dysfunction and functional disability.

The proposed study will be part of a larger program, Portland Identification and Early Referral (PIER), under foundation, NIH and Center for Mental Health Services sponsorship, that has established a population-based system of early detection for Greater Portland, Maine. Previous and present effort has educated and trained the community-at-large and all health, education and other professionals, with the result that referrals are occurring at the expected frequency. The principal strategy is to intervene early, prior to onset, in the course of the onset of psychotic disorders to arrest the development of psychotic symptoms and functional disability. The test treatment is a specialized combination of psychoeducational multifamily group and assertive community treatment.

The project will support a team of clinical staff with the ability to: a. foster detection of prodromal disorders in the Greater Portland community by general practitioners, guidance counselors, mental health professionals and the general public; b. accurately assess individuals at high risk for psychosis; c. reliably deliver an evidence-based psychosocial and, if indicated, pharmacological treatment package using standardized methodology. The research study will test, in a randomized controlled trial, the symptomatic and functional outcome of treatment in 100 subjects ages 12 to 35 identified by that system. It will allow the analysis of key social factors contributing to psychosis and their interaction with the treatment conditions and each other.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Prodromal Schizophrenia
  • Psychotic Disorders
  • Severe Bipolar Disorder With Psychotic Features
  • Severe Major Depression With Psychotic Features
  • Behavioral: Family-aided Assertive Community Treatment
    The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
  • Behavioral: Enhanced standard treatment
    In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention
  • Experimental: Family-aided Assertive Community Treatment
    The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
    Intervention: Behavioral: Family-aided Assertive Community Treatment
  • Active Comparator: Enhanced standard treatment
    In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.
    Intervention: Behavioral: Enhanced standard treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Prodromal psychotic symptoms
  • Age 12-35
  • In catchment area (greater Portland, Maine)

Exclusion Criteria:

  • Previous or current psychotic episode
  • IQ less than 70
  • Outside catchment area
  • Toxic psychosis
Both
12 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01597141
1R01MH065367-01A1
Yes
Not Provided
Not Provided
William McFarlane, Maine Medical Center
Maine Medical Center
  • Columbia University
  • Harvard University
  • University of California, Irvine
Principal Investigator: William R McFarlane, M.D. Maine Medical Center Research Institute
Maine Medical Center
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP