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Specialized Treatment Early in Psychosis (STEP) (STEP)

Primary Purpose

Schizophrenia and Disorders With Psychotic Features

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Group Therapy
Cognitive remediation
Medications
MFG
Assertive case management
Treatment as Usual in the community
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia and Disorders With Psychotic Features focused on measuring First episode psychosis, Specialized care, Phase-specific treatment, Schizophrenia, Disorders with psychotic features

Eligibility Criteria

16 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 16-45 Meets DSM-IV schizophrenia spectrum psychosis or affective psychosis according to the SCID ≤8 weeks of received antipsychotic treatment lifetime at time of referral Willing to be treated in New Haven Exclusion Criteria: Psychosis believed due to substance use (based on the SCID) Unable or unwilling to give informed consent MR as indicated by receipt of services from Dept of Mental Retardation

Sites / Locations

  • Connecticut Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment as usual

STEP Care

Arm Description

Referral to community providers.

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.

Outcomes

Primary Outcome Measures

Number of Patients Hospitalized

Secondary Outcome Measures

Relapse
Data was not collected, instead Hospitalization (primary outcome) was used as a proxy
Overall Functioning- Global Assessment of Functioning
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.
Quality of Life- Heinrich's Quality of Life Scale
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.
Vocationally Engaged
Treatment Satisfaction
Adherence- in Contact With Mental Health Services
Number of participants in contact with mental health services. Collected via self-report.
Substance Use
Subjects Who Committed Self-harm and Violence
The number of subjects who committed an act of self-harm or violence. This data was collected at 12 months.
Medication (Including Metabolic) Side Effects
Economic Measures Including Service Use, Cost of Care and Forensic Data.
Total annual cost per patient

Full Information

First Posted
March 29, 2006
Last Updated
December 12, 2016
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT00309452
Brief Title
Specialized Treatment Early in Psychosis (STEP)
Acronym
STEP
Official Title
Randomized Trial of Usual Care Versus Specialized, Phase-specific Care in the Public Sector for First Episode Psychosis.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia and Disorders With Psychotic Features
Keywords
First episode psychosis, Specialized care, Phase-specific treatment, Schizophrenia, Disorders with psychotic features

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Referral to community providers.
Arm Title
STEP Care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Group Therapy
Intervention Description
once per week
Intervention Type
Behavioral
Intervention Name(s)
Cognitive remediation
Intervention Description
as needed
Intervention Type
Drug
Intervention Name(s)
Medications
Intervention Description
Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
Intervention Type
Behavioral
Intervention Name(s)
MFG
Intervention Description
Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Intervention Type
Behavioral
Intervention Name(s)
Assertive case management
Intervention Description
Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual in the community
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Patients Hospitalized
Time Frame
1 year after enrollment
Secondary Outcome Measure Information:
Title
Relapse
Description
Data was not collected, instead Hospitalization (primary outcome) was used as a proxy
Time Frame
every 6 months
Title
Overall Functioning- Global Assessment of Functioning
Description
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.
Time Frame
12 months
Title
Quality of Life- Heinrich's Quality of Life Scale
Description
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.
Time Frame
12 months
Title
Vocationally Engaged
Time Frame
1 year after enrollment
Title
Treatment Satisfaction
Time Frame
every 6 months
Title
Adherence- in Contact With Mental Health Services
Description
Number of participants in contact with mental health services. Collected via self-report.
Time Frame
1 year
Title
Substance Use
Time Frame
every 6 months
Title
Subjects Who Committed Self-harm and Violence
Description
The number of subjects who committed an act of self-harm or violence. This data was collected at 12 months.
Time Frame
12 months
Title
Medication (Including Metabolic) Side Effects
Time Frame
every 6 months
Title
Economic Measures Including Service Use, Cost of Care and Forensic Data.
Description
Total annual cost per patient
Time Frame
every 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 16-45 Meets DSM-IV schizophrenia spectrum psychosis or affective psychosis according to the SCID ≤8 weeks of received antipsychotic treatment lifetime at time of referral Willing to be treated in New Haven Exclusion Criteria: Psychosis believed due to substance use (based on the SCID) Unable or unwilling to give informed consent MR as indicated by receipt of services from Dept of Mental Retardation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vinod H Srihari, M.D.
Organizational Affiliation
Yale University School of Medicine & Connecticut Mental Health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Woods, M.D.
Organizational Affiliation
Yale University
Official's Role
Study Chair
Facility Information:
Facility Name
Connecticut Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19880454
Citation
Srihari VH, Breitborde NJ, Pollard J, Tek C, Hyman L, Frisman LK, McGlashan TH, Jacobs S, Woods SW. Public-academic partnerships: early intervention for psychotic disorders in a community mental health center. Psychiatr Serv. 2009 Nov;60(11):1426-8. doi: 10.1176/appi.ps.60.11.1426.
Results Reference
background
PubMed Identifier
19880465
Citation
Breitborde NJ, Woods SW, Srihari VH. Multifamily psychoeducation for first-episode psychosis: a cost-effectiveness analysis. Psychiatr Serv. 2009 Nov;60(11):1477-83. doi: 10.1176/ps.2009.60.11.1477.
Results Reference
background
PubMed Identifier
20536970
Citation
Breitborde NJ, Srihari VH, Pollard JM, Addington DN, Woods SW. Mediators and moderators in early intervention research. Early Interv Psychiatry. 2010 May;4(2):143-52. doi: 10.1111/j.1751-7893.2010.00177.x.
Results Reference
background
PubMed Identifier
19548785
Citation
Saksa JR, Cohen SJ, Srihari VH, Woods SW. Cognitive behavior therapy for early psychosis: a comprehensive review of individual vs. group treatment studies. Int J Group Psychother. 2009 Jul;59(3):357-83. doi: 10.1521/ijgp.2009.59.3.357.
Results Reference
background
PubMed Identifier
22642728
Citation
Breitborde NJ, Srihari VH, Woods SW. Review of the operational definition for first-episode psychosis. Early Interv Psychiatry. 2009 Nov;3(4):259-65. doi: 10.1111/j.1751-7893.2009.00148.x.
Results Reference
background
PubMed Identifier
22929869
Citation
Srihari VH, Shah J, Keshavan MS. Is early intervention for psychosis feasible and effective? Psychiatr Clin North Am. 2012 Sep;35(3):613-31. doi: 10.1016/j.psc.2012.06.004. Epub 2012 Jul 21.
Results Reference
background
PubMed Identifier
21762843
Citation
Ozkan B, Phutane V, Jonas E, Tek C, Srihari V. Hoofbeats and zebras: neurodegenerative disorder presenting as a "first episode" of psychosis. Gen Hosp Psychiatry. 2011 Jul-Aug;33(4):412.e1-3. doi: 10.1016/j.genhosppsych.2011.03.011. Epub 2011 May 5.
Results Reference
background
PubMed Identifier
21807825
Citation
Dodds TJ, Phutane VH, Stevens BJ, Woods SW, Sernyak MJ, Srihari VH. Who is paying the price? Loss of health insurance coverage early in psychosis. Psychiatr Serv. 2011 Aug;62(8):878-81. doi: 10.1176/ps.62.8.pss6208_0878.
Results Reference
result
PubMed Identifier
22060947
Citation
Perez VB, Ford JM, Roach BJ, Woods SW, McGlashan TH, Srihari VH, Loewy RL, Vinogradov S, Mathalon DH. Error monitoring dysfunction across the illness course of schizophrenia. J Abnorm Psychol. 2012 May;121(2):372-87. doi: 10.1037/a0025487. Epub 2011 Nov 7.
Results Reference
result
PubMed Identifier
22445463
Citation
Breitborde NJ, Kleinlein P, Srihari VH. Self-determination and first-episode psychosis: associations with symptomatology, social and vocational functioning, and quality of life. Schizophr Res. 2012 May;137(1-3):132-6. doi: 10.1016/j.schres.2012.02.026. Epub 2012 Mar 22.
Results Reference
result
PubMed Identifier
21242060
Citation
Phutane VH, Tek C, Chwastiak L, Ratliff JC, Ozyuksel B, Woods SW, Srihari VH. Cardiovascular risk in a first-episode psychosis sample: a 'critical period' for prevention? Schizophr Res. 2011 Apr;127(1-3):257-61. doi: 10.1016/j.schres.2010.12.008. Epub 2011 Jan 15.
Results Reference
result
PubMed Identifier
25639994
Citation
Srihari VH, Tek C, Kucukgoncu S, Phutane VH, Breitborde NJ, Pollard J, Ozkan B, Saksa J, Walsh BC, Woods SW. First-Episode Services for Psychotic Disorders in the U.S. Public Sector: A Pragmatic Randomized Controlled Trial. Psychiatr Serv. 2015 Jul;66(7):705-12. doi: 10.1176/appi.ps.201400236. Epub 2015 Feb 2.
Results Reference
result
Links:
URL
http://www.step.yale.edu
Description
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