Academic-Community EPINET (AC-EPINET)

Indiana University

Status: Completed

Conditions: Schizophreniform Disorders; Schizophrenia; Bipolar Disorder With Psychotic Features; Schizoaffective Disorder; Major Depression With Psychotic Features

Treatments: Other: Coordinated Specialty Care (CSC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04497857

epinet

5R01MH120588-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

160 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.

Enrollment: 74 patients

Sex: All

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups, including a placebo group

CSC-SD

Placebo Comparator group

Description:

Standard clinic-based CSC model treatment. Treatment will be delivered largely in clinic for 12 months.

Treatment:

Other: Coordinated Specialty Care (CSC)

CSC-TH

Experimental group

Description:

Telehealth based CSC model treatment. Treatment will be delivered largely through telehealth for 12 months.

Treatment:

Other: Coordinated Specialty Care (CSC)