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Completed

NCT Number: NCT00309452

Specialized Treatment Early in Psychosis (STEP)

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.

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Key information

Conditions

Schizophrenia and Disorders With Psychotic Features Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

16 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive behavioral group therapy

Behavioral

once per week

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.

Primary outcomes

  1. Number of Patients Hospitalized

    Time frame: 1 year after enrollment

Secondary outcomes

  1. Relapse

    Time frame: every 6 months

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

  2. 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.

  3. 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.

  4. Vocationally Engaged

    Time frame: 1 year after enrollment

  5. Treatment Satisfaction

    Time frame: every 6 months

  6. Adherence- in Contact With Mental Health Services

    Time frame: 1 year

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

  7. Substance Use

    Time frame: every 6 months

  8. 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.

  9. Medication (Including Metabolic) Side Effects

    Time frame: every 6 months

  10. Economic Measures Including Service Use, Cost of Care and Forensic Data.

    Time frame: every 6 months

    Total annual cost per patient

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Randomized Trial of Usual Care Versus Specialized, Phase-specific Care in the Public Sector for First Episode Psychosis.

Acronym: STEP

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Mar 31, 2006
Registry last updated
Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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