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Completed

NCT Number: NCT04497857

Academic-Community EPINET (AC-EPINET)

The investigators propose to examine the effects of CSC services delivered via TH (CSC-TH) versus the standard clinic-based CSC model (CSC-SD) on engagement and outcomes in a 12-month, randomized trial.

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Key information

Conditions

Schizophrenia Bipolar Disorder With Psychotic Features Major Depression With Psychotic Features Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders Schizophreniform Disorders

Age range

16 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prevention and Recovery Center for Early Psychosis, Indianapolis, Indiana, United States

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About this study

160 subjects will be randomized into a 12 month study, to one of two treatment arms. The investigators will assess four important elements of engagement to determine which are most sensitive to TH treatment and mediates effects on hospitalization rates. The investigators will assess acceptability and satisfaction of CSC-TH compared to CSC-SD, and deliver a training manual for implementing TH in CSC clinics and for use in future research. Although this study has exploratory aims consistent with pilot projects, The investigators have incorporated methodological rigor where possible (randomization, powering for hospitalization rate) in order to achieve the most robust data to assess the main study questions and inform future trials.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Between 16 and 35 years of age
  • Able to give informed consent
  • Willing and able to adhere to the study schedule
  • New intakes enrolled in one of the six clinical programs
  • Non-affective (schizophrenia, schizoaffective, schizophreniform) and affective (major depression with psychotic features, bipolar disorder with psychotic features) psychotic disorders with onsets within 5 years of enrollment.

Exclusion criteria

  • Known IQ < 70 based on participant report

Treatment and study plan

Coordinated Specialty Care (CSC)

Other

CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders

Primary outcomes

  1. Annualized hospitalization rates

    Time frame: 12 months

    To determine if CSC-TH, as compared to CSC-SD, is associated with superior clinical outcomes by counting the number of hospitalizations in a year

Secondary outcomes

  1. Number of participants hospitalized

    Time frame: 12 months

    Count of the number of participants hospitalized (adjusted for time in treatment)

  2. Time (days) to first hospitalization

    Time frame: 12 months

    Count of the time in days to first hospitalization

  3. Symptom outcomes assessed by the Modified Colorado Symptom Index (MCSI)

    Time frame: 12 months

    The modified Colorado Symptom Index (MCSI) is a 14-item, self-report scale designed to assess frequency of positive mood and cognitive symptoms in psychosis. Items are rated on a 5-point Likert-style scale (Not at all, Once during the month, Several times during the month, Several times a week, at least every day). Each item is scored on a 0-4 scale (not at all = 0; at least every day = 4) and added together to give a score between 0 and 56, with higher scores indicating greater emotional distress.

  4. Symptom outcomes assessed by the COMPASS-10

    Time frame: 12 months

    The COMPASS10 consists of 10 items selected from the COMPASS scale developed for the RAISE ETP study. The COMPASS-10 is a clinician-rated assessment of symptom severity in psychosis. There are 10 items measuring anxiety, asociality, avolition, depression, disorganization, hallucinations, hostility, suicidal ideation or behavior, suspiciousness and unusual thought content. The items are rated on a Likert scale from 0 to 6 (0 = not present, 1 =very mild, 2 = mild, 3 = moderate 4= moderately severe, 5 = severe, 6= very severe), with higher scores indicating increased severity of symptoms. For each item, assessors provide ratings of symptom severity after sufficient information is obtained through probe questions.

  5. Functioning outcomes assessed by the MIRECC-GAF

    Time frame: 12 months

    The MIRECC GAF ( Mental Illness Research, Education, and Clinical Center Global Assessment of Functioning) is a three scale assessment of symptom severity, occupational/school functioning, and social functioning. It is scored from 0-100, with a lower score representing worse symptoms/functioning and higher scores representing better functioning. This assessment has been found to have high levels of reliability, concurrent, and predictive validity. It is completed by a trained rater and is expected to take 5 minutes to complete, as the information needed to score the participants will be gathered in various aspects of the assessment process.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Ohio State University
  • Tulane University
  • University of Michigan
  • University of Rochester
  • Vanderbilt University
  • Yale University

Registry information

Official study title

Academic-Community EPINET (AC-EPINET): Mitigating Barriers to Care PILOT

Acronym: AC-EPINET

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 4, 2020
Registry last updated
Dec 24, 2025

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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