Clinical Trial: Psychosis: Early Detection, Intervention and Prevention

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Psychosis: Early Detection, Intervention and Prevention

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.

Detailed Summary:

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.


Sponsor: Maine Medical Center

Current Primary Outcome: 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.


Original Primary Outcome: Onset of Psychosis [ Time Frame: From Baseline 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 on the scale assessing prodromal psychotic symptoms.


Current Secondary Outcome: 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.


Original Secondary Outcome:

  • Functioning [ Time Frame: Baseline, 6, 12, 18 24 and 60 months ]
    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 ]
    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.


Information By: Maine Medical Center

Dates:
Date Received: May 9, 2012
Date Started: May 2003
Date Completion:
Last Updated: January 7, 2016
Last Verified: January 2016