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Specialized Treatment Early in Psychosis (STEP) (STEP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00309452
First received: March 29, 2006
Last updated: September 12, 2016
Last verified: September 2016
Results First Received: May 25, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia and Disorders With Psychotic Features
Interventions: Behavioral: Cognitive Behavioral Group Therapy
Behavioral: Cognitive remediation
Drug: Medications
Behavioral: MFG
Behavioral: Assertive case management
Other: Treatment as Usual in the community

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 512 requests for information, of which 491 were screened by phone for eligibility. 284 were excluded. Of the 207 who completed a full in-person eligibility assessment, 2 were deemed ineligible and 29 were provided STEP care without randomization in an initial pilot (data not included). 120 of the remaining 176 patients were enrolled.

Reporting Groups
  Description
Treatment as Usual

Referral to community providers.

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.

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.

Cognitive Behavioral Group Therapy: once per week

Cognitive remediation: as needed

Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.

MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.

Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports.


Participant Flow:   Overall Study
    Treatment as Usual   STEP Care
STARTED   60   60 
COMPLETED   57   60 
NOT COMPLETED   3   0 
Withdrawal by Subject                3                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment as Usual

Referral to community providers.

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.

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.

Cognitive Behavioral Group Therapy: once per week

Cognitive remediation: as needed

Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.

MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.

Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports.

Total Total of all reporting groups

Baseline Measures
   Treatment as Usual   STEP Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 57   60   117 
Age 
[Units: Years]
Mean (Standard Deviation)
 22.6  (5.3)   22.4  (4.5)   22.5  (4.9) 
Gender 
[Units: Participants]
     
Female   11   11   22 
Male   46   49   95 
Global Assessment of Functioning [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 34.42  (10.43)   36.22  (12.89)   35.88  (13.04) 
[1] 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. The higher the score, the better functioning the subject.
PANNS Positive and Negative Symptom Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Positive Dimension   19.60  (5.90)   20.75  (6.74)   20.21  (6.36) 
Negative Dimension   17.01  (5.40)   17.82  (6.42)   17.44  (5.95) 
General Symptoms   33.70  (8.56)   33.42  (8.62)   33.56  (8.56) 
Total   70.33  (15.52)   72.0  (16.76)   71.21  (16.14) 
[1]

The Positive scale has7 Items, (minimum score = 7, maximum score = 49). With a higher score indicates more severe symptoms.

The Negative scale has 7 Items, (minimum score = 7, maximum score = 49). With a higher score indicates more severe symptoms.

The General Psychopathology scale has 16 Items, (minimum score = 16, maximum score = 112). With a higher score indicates more severe symptoms.

The range for the PANSS Total score is minimum = 30, maximum = 210. With a higher score indicates more severe symptoms.



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

2.  Secondary:   Relapse   [ Time Frame: every 6 months ]

3.  Secondary:   Overall Functioning- Global Assessment of Functioning   [ Time Frame: 12 months ]

4.  Secondary:   Quality of Life- Heinrich's Quality of Life Scale   [ Time Frame: 12 months ]

5.  Secondary:   Vocationally Engaged   [ Time Frame: 1 year after enrollment ]

6.  Secondary:   Treatment Satisfaction   [ Time Frame: every 6 months ]

7.  Secondary:   Adherence- in Contact With Mental Health Services   [ Time Frame: 1 year ]

8.  Secondary:   Subjects What Committed Self-harm and Violence   [ Time Frame: every 6 months ]

9.  Secondary:   Medication (Including Metabolic) Side Effects   [ Time Frame: every 6 months ]

10.  Secondary:   Economic Measures Including Service Use, Cost of Care and Forensic Data.   [ Time Frame: every 6 months ]

11.  Secondary:   Substance Use   [ Time Frame: every 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Vinod H. Srihari
Organization: Yale University
phone: 2039747816
e-mail: vinod.srihari@yale.edu


Publications of Results:
Other Publications:


Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00309452     History of Changes
Other Study ID Numbers: 0601001013
Study First Received: March 29, 2006
Results First Received: May 25, 2016
Last Updated: September 12, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration