Academic-Community EPINET (AC-EPINET)
- Conditions
- SchizophreniaSchizoaffective DisorderSchizophreniform DisordersMajor Depression with Psychotic FeaturesBipolar Disorder with Psychotic Features
- Interventions
- Other: Coordinated Specialty Care (CSC)
- Registration Number
- NCT04497857
- Lead Sponsor
- Indiana University
- Brief Summary
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.
- Detailed Description
180 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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.
- Known IQ < 70 based on participant report
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CSC-SD Coordinated Specialty Care (CSC) Standard clinic-based CSC model treatment. Treatment will be delivered largely in clinic for 12 months. CSC-TH Coordinated Specialty Care (CSC) Telehealth based CSC model treatment. Treatment will be delivered largely through telehealth for 12 months.
- Primary Outcome Measures
Name Time Method Annualized hospitalization rates 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 Outcome Measures
Name Time Method Time (days) to first hospitalization 12 months Count of the time in days to first hospitalization
Symptom and functioning outcomes assessed by the MIRECC-GAF 12 months The MIRECC GAF 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.
Number of participants hospitalized 12 months Count of the number of participants hospitalized (adjusted for time in treatment)
Trial Locations
- Locations (6)
Prevention and Recovery Center for Early Psychosis
🇺🇸Indianapolis, Indiana, United States
Early Psychosis Intervention Clinic-New Orleans (EPIC-NOLA) - Tulane University
🇺🇸New Orleans, Louisiana, United States
Program for Risk Evaluation and Prevention (PREP) - University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Strong Ties Young Adults Program- University of Rochester Medical Center
🇺🇸Rochester, New York, United States
The Early Psychosis Intervention Center (EPICENTER) at Ohio State
🇺🇸Columbus, Ohio, United States
Vanderbilt's Early Psychosis Program - Vanderbilt University
🇺🇸Nashville, Tennessee, United States