Psychosis: Early Detection, Intervention and Prevention

NCT ID: NCT01597141

Last Updated: 2016-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2014-12-31

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 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Family-aided Assertive Community Treatment

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

Group Type: EXPERIMENTAL

Family-aided Assertive Community Treatment

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Enhanced standard treatment

Intervention Type: BEHAVIORAL

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

Interventions

Family-aided Assertive Community Treatment

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: collaborator

Harvard University

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: collaborator

MaineHealth

OTHER

Sponsor Role: lead

Responsible Party

William McFarlane

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William R McFarlane, M.D.

Role: PRINCIPAL_INVESTIGATOR

MaineHealth

Locations

Maine Medical Center

Portland, Maine, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24632857 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23434505 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20439374 (View on PubMed)

Related Links

http://www.preventmentalillness.org

Describes risk factors for psychosis, current scientific understanding of psychosis and means of accessing services

Other Identifiers

1R01MH065367-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link