Psychosis: Early Detection, Intervention and Prevention (EDIP)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 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 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 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 96 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.
| Condition | Intervention |
|---|---|
|
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Psychosis: Early Detection, Intervention and Prevention |
- 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 on the scale assessing prodromal psychotic symptoms.
- 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.
| Enrollment: | 100 |
| Study Start Date: | May 2003 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 12 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Maine | |
| Maine Medical Center | |
| Portland, Maine, United States, 04102 | |
| Principal Investigator: | William R McFarlane, M.D. | Maine Medical Center Research Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | William McFarlane, Principal Investigator, Maine Medical Center |
| ClinicalTrials.gov Identifier: | NCT01597141 History of Changes |
| Other Study ID Numbers: | 1 R01 MH065367-01A1 |
| Study First Received: | May 9, 2012 |
| Last Updated: | May 10, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Maine Medical Center:
|
Prodromal Schizophrenia Psychosis Family psychoeducation |
Assertive community treatment Supported employment Supported education |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Schizotypal Personality Disorder Mental Disorders Psychotic Disorders Schizophrenia Depressive Disorder, Major Affective Disorders, Psychotic |
Mood Disorders Behavioral Symptoms Personality Disorders Schizophrenia and Disorders with Psychotic Features Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013