Psychosis: Early Detection, Intervention and Prevention (EDIP)

• ClinicalTrials.gov Identifier: NCT01597141
• Recruitment Status: Completed
• First Posted: May 11, 2012
• Results First Posted: February 8, 2016
• Last Update Posted: February 8, 2016
• Sponsor: MaineHealth
• Collaborators: Columbia University; Harvard University; University of California, Irvine
• Information provided by (Responsible Party): William McFarlane, MaineHealth

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Prodromal Schizophrenia; Psychotic Disorders; Severe Bipolar Disorder With Psychotic Features; Severe Major Depression With Psychotic Features	Behavioral: Family-aided Assertive Community Treatment; Behavioral: Enhanced standard treatment	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Psychosis: Early Detection, Intervention and Prevention
• Study Start Date: May 2003
• Actual Primary Completion Date: September 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Family-aided Assertive Community Treatment; The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.	Behavioral: Family-aided Assertive Community Treatment; The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
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.	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

Outcome Measures

Primary Outcome Measures :

1. Onset of Psychosis [ Time Frame: From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months ]
   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.

Secondary Outcome Measures :

1. Functioning [ Time Frame: 24 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 35 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Maine

Maine Medical Center

Portland, Maine, United States, 04102

Sponsors and Collaborators

MaineHealth

Columbia University

Harvard University

University of California, Irvine

Investigators

• Principal Investigator: William R McFarlane, M.D.; MaineHealth

More Information

Publications of Results:

McFarlane WR, Cook WL, Downing D, Verdi MB, Woodberry KA, Ruff A. Portland identification and early referral: a community-based system for identifying and treating youths at high risk of psychosis. Psychiatr Serv. 2010 May;61(5):512-5. doi: 10.1176/appi.ps.61.5.512.

Other Publications:

McFarlane WR, Susser E, McCleary R, Verdi M, Lynch S, Williams D, McKeague IW. Reduction in incidence of hospitalizations for psychotic episodes through early identification and intervention. Psychiatr Serv. 2014 Oct;65(10):1194-200. doi: 10.1176/appi.ps.201300336.

Woodberry KA, McFarlane WR, Giuliano AJ, Verdi MB, Cook WL, Faraone SV, Seidman LJ. Change in neuropsychological functioning over one year in youth at clinical high risk for psychosis. Schizophr Res. 2013 May;146(1-3):87-94. doi: 10.1016/j.schres.2013.01.017. Epub 2013 Feb 22.

• Responsible Party: William McFarlane, Principal Investigator, MaineHealth
• ClinicalTrials.gov Identifier: NCT01597141
• Other Study ID Numbers: 1R01MH065367-01A1 ( U.S. NIH Grant/Contract )
• First Posted: May 11, 2012
• Results First Posted: February 8, 2016
• Last Update Posted: February 8, 2016
• Last Verified: January 2016

Keywords provided by William McFarlane, MaineHealth:

Prodromal; Schizophrenia; Psychosis; Family psychoeducation; Assertive community treatment; Supported employment; Supported education

Additional relevant MeSH terms:

Disease; Schizophrenia; Bipolar Disorder; Psychotic Disorders; Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders