Specialized Treatment Early in Psychosis (STEP)

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00309452
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 89
• Patients Per Site Per Month: 1.3

Study Details

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.

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	N/A

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

• Study Type: Interventional
• 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: Mar 1, 2006
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

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

Primary Outcome Measures

1. Number of Patients Hospitalized [1 year after enrollment]

Secondary Outcome Measures

1. Relapse [every 6 months]

   Data was not collected, instead Hospitalization (primary outcome) was used as a proxy

2. Overall Functioning- Global Assessment of Functioning [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 [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 [1 year after enrollment]

5. Treatment Satisfaction [every 6 months]

6. Adherence- in Contact With Mental Health Services [1 year]

   Number of participants in contact with mental health services. Collected via self-report.

7. Substance Use [every 6 months]

8. Subjects Who Committed Self-harm and Violence [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 [every 6 months]

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

    Total annual cost per patient

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Connecticut Mental Health Center	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

• 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. Review.
• 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. Review.
• 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/appi.ps.60.11.1477.
• 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.
• 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. Review.
• 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.
• 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. Review.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00309452
• Other Study ID Numbers: 0601001013
• First Posted: Mar 31, 2006
• Last Update Posted: Feb 8, 2017
• Last Verified: Dec 1, 2016

• Keywords provided by Yale University: First episode psychosis; Specialized care; Phase-specific treatment; Schizophrenia; Disorders with psychotic features
• Additional relevant MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Treatment as Usual	STEP Care
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	60	60
COMPLETED	57	60
NOT COMPLETED	3	0

Baseline Characteristics

Arm/Group Title	Treatment as Usual	STEP Care	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	57	60	117
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	22.6 (5.3)	22.4 (4.5)	22.5 (4.9)
Gender (Count of Participants)
Female	11 19.3%	11 18.3%	22 18.8%
Male	46 80.7%	49 81.7%	95 81.2%
Global Assessment of Functioning (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	34.42 (10.43)	36.22 (12.89)	35.88 (13.04)
PANNS Positive and Negative Symptom Scale (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)

Outcome Measures

1. Primary Outcome

Title	Number of Patients Hospitalized
Time Frame	1 year after enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment as Usual	STEP Care
Arm/Group Description	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.	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.
Measure Participants	57	60
Number [participants]	25 43.9%	14 23.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment as Usual, STEP Care
	Comments	Between groups comparison for hospitalization rates, adjusted for pretreatment hospitalization
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.018
	Comments
	Method	Chi-squared, Corrected
	Comments

2. Secondary Outcome

Title	Relapse
Description	Data was not collected, instead Hospitalization (primary outcome) was used as a proxy
Time Frame	every 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment as Usual	STEP Care
Arm/Group Description	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.	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.
Measure Participants	0	0

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment as Usual	STEP Care
Arm/Group Description	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.	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.
Measure Participants	57	60
Baseline	34.42 (10.43)	36.22 (12.89)
Change from baseline	20.38 (16.61)	22.22 (15.46)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment as Usual	STEP Care
Arm/Group Description	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.	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.
Measure Participants	57	60
Baseline	59.45 (18.02)	59.87 (22.25)
Change from Baseline	-.80 (20.18)	9.81 (29.85)

5. Secondary Outcome

Title	Vocationally Engaged
Time Frame	1 year after enrollment

Outcome Measure Data

Analysis Population Description

20 subjects from the treatment as usual arm were lost to follow-up. 12 subjects from STEP Care arm were lost to follow up.

Arm/Group Title	Treatment as Usual	STEP Care
Arm/Group Description	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.	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.
Measure Participants	37	48
Number [participants]	26 45.6%	44 73.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment as Usual, STEP Care
	Comments	Between groups comparison for vocational engagement, adjusted for pretreatment vocational engagement
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Chi-squared, Corrected
	Comments

6. Secondary Outcome

Title	Treatment Satisfaction
Time Frame	every 6 months

Outcome Measure Data

Analysis Population Description

Data was not collected

Arm/Group Title	Treatment as Usual	STEP Care
Arm/Group Description	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.	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.
Measure Participants	0	0

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients were lost to follow up. 15 subjects in the Treatment as Usual arm, and 15 subjects in the STEP care arm.

Arm/Group Title	Treatment as Usual	STEP Care
Arm/Group Description	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.	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.
Measure Participants	42	45
Number [participants]	33 57.9%	39 65%

8. Secondary Outcome

Title	Substance Use
Time Frame	every 6 months

Outcome Measure Data

Analysis Population Description

This was not a planned primary or secondary outcome in our analysis (though collected at baseline) and because of significant attrition we did not report on this outcome despite having phone call f/u data on other outcomes. We did not believe phone reports on this outcome would produce reliable data.

Arm/Group Title	Treatment as Usual	STEP Care
Arm/Group Description	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.	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.
Measure Participants	0	0

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This data was collected, numbers reflect actual data.

Arm/Group Title	Treatment as Usual	STEP Care
Arm/Group Description	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.	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.
Measure Participants	57	60
Number [participants]	0 0%	0 0%

10. Secondary Outcome

Title	Medication (Including Metabolic) Side Effects
Time Frame	every 6 months

Outcome Measure Data

Analysis Population Description

data no collected

Arm/Group Title	Treatment as Usual	STEP Care
Arm/Group Description	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.	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.
Measure Participants	0	0

11. Secondary Outcome

Title	Economic Measures Including Service Use, Cost of Care and Forensic Data.
Description	Total annual cost per patient
Time Frame	every 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment as Usual	STEP Care
Arm/Group Description	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.	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.
Measure Participants	57	60
Mean (Standard Error) [dollars]	12157.46 (2948.83)	7625.22 (2539.70)

Adverse Events

Arm/Group Title	Treatment as Usual		STEP Care
Arm/Group Description	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.		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.
All Cause Mortality
	Treatment as Usual		STEP Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Treatment as Usual		STEP Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Treatment as Usual		STEP Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.