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

  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

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

ArmDescriptionAssigned Intervention
Placebo Comparator
CSC-SD 		Standard clinic-based CSC model treatment. Treatment will be delivered largely in clinic for 12 months.
  • Other: Coordinated Specialty Care (CSC)
    CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders
Experimental
CSC-TH 		Telehealth based CSC model treatment. Treatment will be delivered largely through telehealth for 12 months.
  • Other: Coordinated Specialty Care (CSC)
    CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders

Recruiting Locations

Early Psychosis Intervention Clinic-New Orleans (EPIC-NOLA) - Tulane University
New Orleans, Louisiana 70119
Contact:
Ashley Weiss
504-236-5009
aweiss3@tulane.edu

More Details

Status
Recruiting
Sponsor
Indiana University

Study Contact

Research Manager
3178808438
iupdp@iupui.edu

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.