Specialized Treatment Early in Psychosis (STEP) (STEP)
|ClinicalTrials.gov Identifier: NCT00309452|
Recruitment Status : Completed
First Posted : March 31, 2006
Results First Posted : October 31, 2016
Last Update Posted : February 8, 2017
|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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Trial of Usual Care Versus Specialized, Phase-specific Care in the Public Sector for First Episode Psychosis.|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
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 weekBehavioral: Cognitive remediation
as neededDrug: 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.
- Number of Patients Hospitalized [ Time Frame: 1 year after enrollment ]
- Relapse [ Time Frame: every 6 months ]Data was not collected, instead Hospitalization (primary outcome) was used as a proxy
- Overall Functioning- Global Assessment of Functioning [ Time Frame: 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.
- Quality of Life- Heinrich's Quality of Life Scale [ Time Frame: 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.
- 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 ]Number of participants in contact with mental health services. Collected via self-report.
- Substance Use [ Time Frame: every 6 months ]
- Subjects Who Committed Self-harm and Violence [ Time Frame: 12 months ]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 [ Time Frame: every 6 months ]
- Economic Measures Including Service Use, Cost of Care and Forensic Data. [ Time Frame: every 6 months ]Total annual cost per patient
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309452
|United States, Connecticut|
|Connecticut Mental Health Center|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Vinod H Srihari, M.D.||Yale University School of Medicine & Connecticut Mental Health Center|
|Study Chair:||Scott Woods, M.D.||Yale University|