Examining the effects of coordinated specialty care for psychosis
Academic-Community EPINET (AC-EPINET): Mitigating Barriers to Care PILOT
This study is testing if telehealth care for young people with psychotic disorders helps them engage better and feel more satisfied compared to traditional in-person care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 16 Years to 35 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 6 sites (Indianapolis, Indiana and 5 other locations) |
| Trial ID | NCT04497857 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of Coordinated Specialty Care delivered through telehealth (CSC-TH) compared to standard clinic-based care (CSC-SD) on patient engagement and outcomes over a 12-month period. A total of 180 participants aged 16 to 35 with various psychotic disorders will be randomly assigned to one of the two treatment arms. The study aims to evaluate key elements of engagement, hospitalization rates, and patient satisfaction with the different care models. Additionally, a training manual will be developed to facilitate the implementation of telehealth in clinical settings and future research.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 to 35 with recent-onset psychotic disorders who can provide informed consent.
Not a fit: Patients with known IQ below 70 may not benefit from this study due to challenges in understanding and adhering to the study requirements.
Why it matters
Potential benefit: If successful, this study could improve engagement and outcomes for young patients with psychotic disorders through enhanced access to care.
How similar studies have performed: Previous studies have shown promise in using telehealth for mental health interventions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Between 16 and 35 years of age 2. Able to give informed consent 3. Willing and able to adhere to the study schedule 4. New intakes enrolled in one of the six clinical programs 5. 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: 1. Known IQ \< 70 based on participant report
Where this trial is running
Indianapolis, Indiana and 5 other locations
- Prevention and Recovery Center for Early Psychosis — Indianapolis, Indiana, United States (Recruiting)
- Early Psychosis Intervention Clinic-New Orleans (EPIC-NOLA) - Tulane University — New Orleans, Louisiana, United States (Recruiting)
- Program for Risk Evaluation and Prevention (PREP) - University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Strong Ties Young Adults Program- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
- The Early Psychosis Intervention Center (EPICENTER) at Ohio State — Columbus, Ohio, United States (Recruiting)
- Vanderbilt's Early Psychosis Program - Vanderbilt University — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Alan Breier — Indiana Univeristy
- Study coordinator: Research Manager
- Email: iupdp@iupui.edu
- Phone: 3178808438
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.