Psychosis: Early Detection, Intervention and Prevention (EDIP)

MaineHealth

Status: Completed

Conditions: Psychotic Disorders; Severe Major Depression With Psychotic Features; Severe Bipolar Disorder With Psychotic Features; Prodromal Schizophrenia

Treatments: Behavioral: Enhanced standard treatment; Behavioral: Family-aided Assertive Community Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01597141

1R01MH065367-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 12 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Family-aided Assertive Community Treatment

Experimental group

Description:

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

Treatment:

Behavioral: Family-aided Assertive Community Treatment

Enhanced standard treatment

Active Comparator group

Description:

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

Treatment:

Behavioral: Enhanced standard treatment