Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Specialized Treatment Early in Psychosis (STEP) (STEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00309452
Recruitment Status : Completed
First Posted : March 31, 2006
Results First Posted : October 31, 2016
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia and Disorders With Psychotic Features Behavioral: Cognitive Behavioral Group Therapy Behavioral: Cognitive remediation Drug: Medications Behavioral: MFG Behavioral: Assertive case management Other: Treatment as Usual in the community Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Usual Care Versus Specialized, Phase-specific Care in the Public Sector for First Episode Psychosis.
Study Start Date : March 2006
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Patients Hospitalized [ Time Frame: 1 year after enrollment ]

Secondary Outcome Measures :
  1. Relapse [ Time Frame: every 6 months ]
    Data was not collected, instead Hospitalization (primary outcome) was used as a proxy

  2. 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.


  3. 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.


  4. Vocationally Engaged [ Time Frame: 1 year after enrollment ]
  5. Treatment Satisfaction [ Time Frame: every 6 months ]
  6. Adherence- in Contact With Mental Health Services [ Time Frame: 1 year ]
    Number of participants in contact with mental health services. Collected via self-report.

  7. Substance Use [ Time Frame: every 6 months ]
  8. 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.

  9. Medication (Including Metabolic) Side Effects [ Time Frame: every 6 months ]
  10. Economic Measures Including Service Use, Cost of Care and Forensic Data. [ Time Frame: every 6 months ]
    Total annual cost per patient


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309452


Locations
Layout table for location information
United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Layout table for investigator information
Principal Investigator: Vinod H Srihari, M.D. Yale University School of Medicine & Connecticut Mental Health Center
Study Chair: Scott Woods, M.D. Yale University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00309452     History of Changes
Other Study ID Numbers: 0601001013
First Posted: March 31, 2006    Key Record Dates
Results First Posted: October 31, 2016
Last Update Posted: February 8, 2017
Last Verified: December 2016
Keywords provided by Yale University:
First episode psychosis
Specialized care
Phase-specific treatment
Schizophrenia
Disorders with psychotic features
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders