Academic-Community EPINET (AC-EPINET)
Purpose
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.
Conditions
- Schizophrenia
- Schizoaffective Disorder
- Schizophreniform Disorders
- Major Depression with Psychotic Features
- Bipolar Disorder with Psychotic Features
Eligibility
- Eligible Ages
- Between 16 Years and 35 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- Known IQ < 70 based on participant report
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator CSC-SD |
Standard clinic-based CSC model treatment. Treatment will be delivered largely in clinic for 12 months. |
|
|
Experimental CSC-TH |
Telehealth based CSC model treatment. Treatment will be delivered largely through telehealth for 12 months. |
|
Recruiting Locations
New Orleans, Louisiana 70119
More Details
- Status
- Recruiting
- Sponsor
- Indiana University
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.