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

First Episode Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04005378
• Other study ID #: 19-0307 -B
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: May 30, 2024

Study information

• Verified date: September 2023
• Source: Northwell Health
• Contact: Patricia Marcy, BSN
• Phone: 347-439-8035
• Email: pmarcy[@]northwell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 30, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

Inclusion Criteria:

• Enrolled into a CSC program

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• First Episode Psychosis
• Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
United States	InterAct of Michigan	Grand Rapids	Michigan
United States	InterAct of Michigan	Kalamazoo	Michigan
United States	Henderson Behavioral Health	Lauderdale Lakes	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disengagement rate	Rate of disengagement from CSC program	Minimum of 6 months