Academic-Community EPINET (AC-EPINET)

Indiana University74 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Schizophrenia Schizoaffective Disorder Schizophreniform Disorders Major Depression With Psychotic Features Bipolar Disorder With Psychotic Features

Interventions

Coordinated Specialty Care (CSC)OTHER

CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders

Eligibility

Sex: ALLMin age: 16 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Locations (6)

Prevention and Recovery Center for Early Psychosis

Indianapolis, Indiana, United States

Early Psychosis Intervention Clinic-New Orleans (EPIC-NOLA) - Tulane University

New Orleans, Louisiana, United States

Program for Risk Evaluation and Prevention (PREP) - University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Annualized hospitalization rates

To determine if CSC-TH, as compared to CSC-SD, is associated with superior clinical outcomes by counting the number of hospitalizations in a year

Time frame: 12 months

Secondary Outcomes

Number of participants hospitalized

Count of the number of participants hospitalized (adjusted for time in treatment)

Time frame: 12 months

Time (days) to first hospitalization

Count of the time in days to first hospitalization

Time frame: 12 months

Symptom outcomes assessed by the Modified Colorado Symptom Index (MCSI)

The modified Colorado Symptom Index (MCSI) is a 14-item, self-report scale designed to assess frequency of positive mood and cognitive symptoms in psychosis. Items are rated on a 5-point Likert-style scale (Not at all, Once during the month, Several times during the month, Several times a week, at least every day). Each item is scored on a 0-4 scale (not at all = 0; at least every day = 4) and added together to give a score between 0 and 56, with higher scores indicating greater emotional distress.

Time frame: 12 months

Symptom outcomes assessed by the COMPASS-10

The COMPASS10 consists of 10 items selected from the COMPASS scale developed for the RAISE ETP study. The COMPASS-10 is a clinician-rated assessment of symptom severity in psychosis. There are 10 items measuring anxiety, asociality, avolition, depression, disorganization, hallucinations, hostility, suicidal ideation or behavior, suspiciousness and unusual thought content. The items are rated on a Likert scale from 0 to 6 (0 = not present, 1 =very mild, 2 = mild, 3 = moderate 4= moderately severe, 5 = severe, 6= very severe), with higher scores indicating increased severity of symptoms. For each item, assessors provide ratings of symptom severity after sufficient information is obtained through probe questions.

Data from ClinicalTrials.gov

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