Specialized Treatment Early in Psychosis (STEP) (STEP)

December 12, 2016 updated by: Yale University

Randomized Trial of Usual Care Versus Specialized, Phase-specific Care in the Public Sector for First Episode Psychosis.

The purpose of this study is to understand the effectiveness of a specialized package of phase-specific treatments for individuals in the midst of their first episode of psychosis. The pharmacologic and psychosocial treatments will be delivered within a state public mental health center.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We propose to conduct a clinical trial for first episode psychosis patients not eligible for CMHC services that will compare randomized access to care at CMHC versus the usual procedure of referral to community providers outside CMHC. Patients randomized to access to CMHC services will receive multifaceted, intensive, phase-specific care delivered by a specialized clinical team. This care will include five principal components: antipsychotic prescription, multi-family group therapy, group cognitive behavioral therapy, cognitive remediation and individual case management including supportive, problem solving approaches and a focus on resumption of movement towards educational and/or employment related goals. All consenting subjects will undergo research evaluations every six months for up to five years. Outcomes will be assessed in the domains of re-admission (primary outcome), relapse, symptoms, overall functioning, quality of life, education and employment, treatment satisfaction, adherence, substance use, adverse events (including self-harm) and economic measures including service use, cost of care and forensic data.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Connecticut Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 16-45
  2. Meets DSM-IV schizophrenia spectrum psychosis or affective psychosis according to the SCID
  3. ≤8 weeks of received antipsychotic treatment lifetime at time of referral
  4. Willing to be treated in New Haven

Exclusion Criteria:

  1. Psychosis believed due to substance use (based on the SCID)
  2. Unable or unwilling to give informed consent
  3. MR as indicated by receipt of services from Dept of Mental Retardation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment as usual
Referral to community providers.
Other: Treatment as Usual in the community
Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic.
Experimental: STEP Care
Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.
Behavioral: Cognitive Behavioral Group Therapy
once per week
Behavioral: Cognitive remediation
as needed
Drug: Medications
Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
Behavioral: MFG
Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Behavioral: Assertive case management
Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients Hospitalized
Time Frame: 1 year after enrollment
1 year after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse
Time Frame: every 6 months
Data was not collected, instead Hospitalization (primary outcome) was used as a proxy
every 6 months
Overall Functioning- Global Assessment of Functioning
Time Frame: 12 months

The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. A higher score indicates better functioning.

The score reported is a change from baseline. The change was calculated as score at 12 months minus score from baseline. A positive score indicates higher functioning.
12 months
Quality of Life- Heinrich's Quality of Life Scale
Time Frame: 12 months

The Quality of Life Scale (QLS) is a 21-item scale rated from a semistructured interview providing information on symptoms and functioning during the preceding 4 weeks. Each item is rated on a seven point scale, and a higher score reflects normal or unimpaired functioning. The range is from 0 to 126.

The score reflected is a change from baseline. Total score at 12 months minus total score at baseline. A positive score indicates better mental health.
12 months
Vocationally Engaged
Time Frame: 1 year after enrollment
1 year after enrollment
Treatment Satisfaction
Time Frame: every 6 months
every 6 months
Adherence- in Contact With Mental Health Services
Time Frame: 1 year
Number of participants in contact with mental health services. Collected via self-report.
1 year
Substance Use
Time Frame: every 6 months
every 6 months
Subjects Who Committed Self-harm and Violence
Time Frame: 12 months
The number of subjects who committed an act of self-harm or violence. This data was collected at 12 months.
12 months
Medication (Including Metabolic) Side Effects
Time Frame: every 6 months
every 6 months
Economic Measures Including Service Use, Cost of Care and Forensic Data.
Time Frame: every 6 months
Total annual cost per patient
every 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Vinod H Srihari, M.D., Yale University School of Medicine & Connecticut Mental Health Center
  • Study Chair: Scott Woods, M.D., Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

March 29, 2006

First Submitted That Met QC Criteria

March 29, 2006

First Posted (Estimate)

March 31, 2006

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

December 12, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0601001013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia and Disorders With Psychotic Features

Clinical Trials on Treatment as Usual in the community

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe