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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as usual | Active Comparator | Referral to community providers. |
|
| STEP Care | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Group Therapy | Behavioral | once per week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Hospitalized | 1 year after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse | Data was not collected, instead Hospitalization (primary outcome) was used as a proxy | every 6 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vinod H Srihari, M.D. | Yale University School of Medicine & Connecticut Mental Health Center | Principal Investigator |
| Scott Woods, M.D. | Yale University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19880454 | Background | 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. | |
| 19880465 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Hospitalized | Posted | Number | participants | 1 year after enrollment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vinod H. Srihari | Yale University | 2039747816 | vinod.srihari@yale.edu |
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| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000072466 | Cognitive Remediation |
| D004304 | Dosage Forms |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D004364 | Pharmaceutical Preparations |
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| Cognitive remediation |
| Behavioral |
as needed |
|
| Medications | Drug | Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers. |
|
| MFG | Behavioral | Multi-Family psychoeducation Group based on the model published by McFarlane et al. |
|
| Assertive case management | Behavioral | Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports. |
|
| Treatment as Usual in the community | Other | 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. |
|
| 12 months |
| 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. | 12 months |
| Vocationally Engaged | 1 year after enrollment |
| Treatment Satisfaction | every 6 months |
| Adherence- in Contact With Mental Health Services | Number of participants in contact with mental health services. Collected via self-report. | 1 year |
| Substance Use | every 6 months |
| 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. | 12 months |
| Medication (Including Metabolic) Side Effects | every 6 months |
| Economic Measures Including Service Use, Cost of Care and Forensic Data. | Total annual cost per patient | every 6 months |
| 20536970 | Background | 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. |
| 19548785 | Background | 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. |
| 22642728 | Background | 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. |
| 22929869 | Background | 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. |
| 21762843 | Background | 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. |
| 21807825 | Result | 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. |
| 22060947 | Result | 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. |
| 22445463 | Result | 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. |
| 21242060 | Result | 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. |
| 25639994 | Result | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| 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. The higher the score, the better functioning the subject. | Mean | Standard Deviation | units on a scale |
|
| PANNS Positive and Negative Symptom Scale | 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. | Mean | Standard Deviation | units on a scale |
|
|
|
|
| Secondary | Relapse | Data was not collected, instead Hospitalization (primary outcome) was used as a proxy | Posted | every 6 months |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | Vocationally Engaged | 20 subjects from the treatment as usual arm were lost to follow-up. 12 subjects from STEP Care arm were lost to follow up. | Posted | Number | participants | 1 year after enrollment |
|
|
|
|
| Secondary | Treatment Satisfaction | Data was not collected | Posted | every 6 months |
|
|
| Secondary | Adherence- in Contact With Mental Health Services | Number of participants in contact with mental health services. Collected via self-report. | Patients were lost to follow up. 15 subjects in the Treatment as Usual arm, and 15 subjects in the STEP care arm. | Posted | Number | participants | 1 year |
|
|
|
| Secondary | Substance Use | 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. | Posted | every 6 months |
|
|
| Secondary | 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. | This data was collected, numbers reflect actual data. | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Medication (Including Metabolic) Side Effects | data no collected | Posted | every 6 months |
|
|
| Secondary | Economic Measures Including Service Use, Cost of Care and Forensic Data. | Total annual cost per patient | Posted | Mean | Standard Error | dollars | every 6 months |
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | 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. | 0 | 60 | 0 | 60 |
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| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |