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Completed

NCT Number: NCT01597141

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.

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Key information

Age range

12 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maine Medical Center

Portland, Maine, 04102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family-aided Assertive Community Treatment

Behavioral

The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.

Enhanced standard treatment

Behavioral

In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

MaineHealth

Other

Collaborators

  • Columbia University
  • Harvard University
  • University of California, Irvine

Registry information

Acronym: EDIP

Important dates

Study start
2003
Primary completion
2014
Study completion
2014
First posted
May 11, 2012
Registry last updated
Feb 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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