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Recruiting NCT04005378

Disengagement in CSC: Identifying Those at Risk and Addressing Their Needs

Phase IV Interventional First Episode Psychosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CSC Step-down intervention, Usual Care.
Who it may be relevant to
Registry conditions: First Episode Psychosis. Basic parameters: 15 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Maintaining treatment engagement is critical for first episode psychosis patients to experience gains possible with coordinated specialty care (CSC). This study is designed to identify CSC participants still receiving care but at high risk for disengagement and to intervene to prevent/delay disengagement.

Detailed description

In Phase 1 of the project, we will confirm a model predicting factors associated with later disengagement from CSC treatment. In Phase 2, we will compare disengagement among high-risk individuals with a CSC Step-down intervention to that with standard CSC care. The Step-down intervention will use web-based telemedicine and a smartphone app, to decrease disengagement likelihood. High-risk participants identified by predictors found in Phase 1 will be offered the intervention.

Interventions

  • Other CSC Step-down intervention
    Web-based telemedicine and a smartphone app, to decrease disengagement likelihood
  • Other Usual Care
    Usual Care provided by CSC center

Primary outcome measures

  • Disengagement rate [Time frame: Minimum of 6 months]

Eligibility criteria

Inclusion criteria

  • Enrolled into a CSC program

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 3 centers
  • Henderson Behavioral Health — Lauderdale Lakes
  • InterAct of Michigan — Grand Rapids
  • InterAct of Michigan — Kalamazoo

Identifiers

NCT: NCT04005378 · 19-0307 -B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗