Clinical trial NCT04497857: Academic-Community EPINET (AC-EPINET)
Official title: Academic-Community EPINET (AC-EPINET): Mitigating Barriers to Care PILOT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorders
Major Depression with Psychotic Features
Bipolar Disorder with Psychotic Features
Keywords: psychosis
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Ohio State University
name: Vanderbilt University
name: Tulane University
name: University of Rochester
name: Yale University
name: National Institute of Mental Health (NIMH)
First posted: 2020-08-04
Enrollment: 180
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Annualized hospitalization rates
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants hospitalized
timeFrame: 12 months
measure: Time (days) to first hospitalization
timeFrame: 12 months
measure: Symptom and functioning outcomes assessed by the MIRECC-GAF
timeFrame: 12 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Prevention and Recovery Center for Early Psychosis
state: Indiana
city: New Orleans
country: United States
facility: Early Psychosis Intervention Clinic-New Orleans (EPIC-NOLA) - Tulane University
state: Louisiana
city: Ann Arbor
country: United States
facility: Program for Risk Evaluation and Prevention (PREP) - University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Strong Ties Young Adults Program- University of Rochester Medical Center
state: New York
city: Columbus
country: United States
facility: The Early Psychosis Intervention Center (EPICENTER) at Ohio State
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt's Early Psychosis Program - Vanderbilt University
state: Tennessee
Study officials:
affiliation: Indiana Univeristy
name: Alan Breier
role: PRINCIPAL_INVESTIGATOR
References: