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

NCT ID: NCT04005378

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2024-11-30

Brief Summary

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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

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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.

Conditions

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First Episode Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Assigned to either treatment as usual or to the disengagement treatment
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CSC Step-down intervention

Web-based telemedicine and a smartphone app, to decrease disengagement likelihood

Group Type OTHER

CSC Step-down intervention

Intervention Type OTHER

Web-based telemedicine and a smartphone app, to decrease disengagement likelihood

Usual Care

Usual care provided by CSC center

Group Type OTHER

Usual Care

Intervention Type OTHER

Usual Care provided by CSC center

Interventions

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CSC Step-down intervention

Web-based telemedicine and a smartphone app, to decrease disengagement likelihood

Intervention Type OTHER

Usual Care

Usual Care provided by CSC center

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Enrolled into a CSC program

Exclusion Criteria

* None
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Henderson Behavioral Health

Lauderdale Lakes, Florida, United States

Site Status RECRUITING

InterAct of Michigan

Grand Rapids, Michigan, United States

Site Status RECRUITING

InterAct of Michigan

Kalamazoo, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Patricia Marcy, BSN

Role: CONTACT

347-439-8035

Cristina Gonzalez, MS

Role: CONTACT

347-804-3605

Facility Contacts

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Suzelle Guinart

Role: primary

Jacob Gonzales

Role: primary

Dana Schraber

Role: primary

Other Identifiers

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19-0307 -B

Identifier Type: -

Identifier Source: org_study_id

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