Schizophrenia and Disorders With Psychotic FeaturesSTEPNCT00309452
Specialized Treatment Early in Psychosis (STEP)
A study testing Cognitive Behavioral Group Therapy, Cognitive remediation and Medications in people with Schizophrenia and Disorders With Psychotic Features, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Schizophrenia and Disorders With Psychotic Features
- What is being tested?
- Cognitive Behavioral Group Therapy, Cognitive remediation and Medications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Aug 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
Official title: Randomized Trial of Usual Care Versus Specialized, Phase-specific Care in the Public Sector for First Episode Psychosis.
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.
Read the 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.
- Being tested
- Cognitive Behavioral Group Therapy, Cognitive remediation, Medications, MFG, Assertive case management
- Keywords
- First episode psychosis, Specialized care, Phase-specific treatment, Schizophrenia, Disorders with psychotic features
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Group TherapyBehavioural
once per week
Cognitive remediationBehavioural
as needed
MedicationsDrug
Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
MFGBehavioural
Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Assertive case managementBehavioural
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 communityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | Referral to community providers. Receives: Other: Treatment as Usual in the community |
| 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. Receives: Behavioral: Cognitive Behavioral Group Therapy; Behavioral: Cognitive remediation; Drug: Medications; Behavioral: MFG; Behavioral: Assertive case management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Hospitalized
Measured: 1 year after enrollment
Secondary outcomes (10)
Relapse
Data was not collected, instead Hospitalization (primary outcome) was used as a proxy
Measured: 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.
Measured: 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.
Measured: 12 months
Vocationally Engaged
Measured: 1 year after enrollment
Treatment Satisfaction
Measured: every 6 months
Adherence- in Contact With Mental Health Services
Number of participants in contact with mental health services. Collected via self-report.
Measured: 1 year
Substance Use
Measured: 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.
Measured: 12 months
Medication (Including Metabolic) Side Effects
Measured: every 6 months
Economic Measures Including Service Use, Cost of Care and Forensic Data.
Total annual cost per patient
Measured: every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia and Disorders With Psychotic FeaturesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vinod H Srihari, M.D., Principal investigator, Yale University School of Medicine & Connecticut Mental Health CenterScott Woods, M.D., Study chair, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309452
- Sponsor's protocol ID
- 0601001013
- Acronym
- STEP
- Status last verified
- Dec 2016
- First submitted
- 29 Mar 2006
- Last updated
- 8 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 19880454Breitborde 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.
PubMed 19880465Breitborde 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.
PubMed 20536970Saksa 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.
PubMed 19548785Breitborde 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.
PubMed 22642728Srihari 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.
PubMed 22929869Ozkan 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.
PubMed 21762843Dodds 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.
PubMed 21807825Perez 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.
PubMed 22060947Breitborde 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.
PubMed 22445463Phutane 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.
PubMed 21242060Srihari 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.
PubMed 25639994
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Usual Care Versus Specialized, Phase-specific Care in the Public Sector for First Episode Psychosis.
- ClinicalTrials.gov ID
- NCT00309452
- Acronym / sponsor ID
- STEP / 0601001013
- Keywords
- First episode psychosis, Specialized care, Phase-specific treatment, Schizophrenia, Disorders with psychotic features
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 31 Mar 2006 (estimated)
- Results
- Posted 31 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Other: Treatment as Usual in the communityReferral to community providers. |
| STEP Care | Experimental | Behavioral: Cognitive Behavioral Group Therapy, Behavioral: Cognitive remediation, Drug: Medications, Behavioral: MFG, Behavioral: Assertive case managementIntegrated 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. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Group Therapyonce per week | Behavioural | STEP Care |
| Cognitive remediationas needed | Behavioural | STEP Care |
| MedicationsIndividualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers. | Drug | STEP Care |
| MFGMulti-Family psychoeducation Group based on the model published by McFarlane et al. | Behavioural | STEP Care |
| Assertive case managementMeetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports. | Behavioural | STEP Care |
| Treatment as Usual in the communitySubjects 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. | Other | Treatment as usual |
Primary outcome
Number of Patients Hospitalized
Time frame: 1 year after enrollment
10 secondary outcomes
Relapse
Time frame: every 6 months
Overall Functioning- Global Assessment of Functioning
Time frame: 12 months
Quality of Life- Heinrich's Quality of Life Scale
Time frame: 12 months
Vocationally Engaged
Time frame: 1 year after enrollment
Treatment Satisfaction
Time frame: every 6 months
Adherence- in Contact With Mental Health Services
Time frame: 1 year
Substance Use
Time frame: every 6 months
Subjects Who Committed Self-harm and Violence
Time frame: 12 months
Medication (Including Metabolic) Side Effects
Time frame: every 6 months
Economic Measures Including Service Use, Cost of Care and Forensic Data.
Time frame: every 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19880454Srihari 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.
- Background: PubMed 19880465Breitborde 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.
- Background: PubMed 20536970Breitborde 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.
- Background: PubMed 19548785Saksa 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.
- Background: PubMed 22642728Breitborde 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.
- Background: PubMed 22929869Srihari 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.
- Background: PubMed 21762843Ozkan 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 publication: PubMed 21807825Dodds 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 publication: PubMed 22060947Perez 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 publication: PubMed 22445463Breitborde 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 publication: PubMed 21242060Phutane 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 publication: PubMed 25639994Srihari 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinod H Srihari, M.D. principal investigator
Yale University School of Medicine & Connecticut Mental Health Center
Scott Woods, M.D. study chair
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Group Therapy, Cognitive remediation and Medications in people with Schizophrenia and Disorders With Psychotic Features, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Hospitalized (time frame: 1 year after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00309452, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2017.