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Behavioral Intervention

Enhanced Care for Psychosis

N/A

Recruiting

Led By Dost Ongur, MD, PhD

Research Sponsored by Mclean Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if adding certain elements of care to the standard treatment for first-episode psychosis will increase the number of clinic visits. Participants will either receive the standard care or the standard care with

Who is the study for?

This trial is for individuals experiencing their first episode of psychosis, which could be related to conditions like schizophrenia or bipolar disorder. Participants must be receiving care at specific clinics in Massachusetts and are excluded if they don't attend these clinics.

What is being tested?

The study compares standard coordinated specialty care (CSC) with an enhanced version (CSC 2.0), which adds individual peer support, digital outreach, extra care coordination, multi-family group therapy, and cognitive remediation to see if it increases clinic visits.

What are the potential side effects?

Since the interventions involve additional support services rather than medications, traditional side effects are not a concern; however, participants may experience varying levels of comfort or emotional responses to the different types of therapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Months Engaged in Care

Secondary study objectives

Clinic Visit Number

Clinic Visit Type

Duration of Treatment

+1 more

Other study objectives

Exploratory Analysis of symptom and functioning measures in EPINET Core Assessment Battery (CAB)

Months Engaged in Care - extension of

Proportion of Early Detachment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Enhanced Coordinated Speciality Care (CSC 2.0)Experimental Treatment5 Interventions

CSC 2.0 arm will be offered 1:1 peer support, digital outreach, care coordination, multi-family group therapy, and cognitive remediation (if applicable).

Group II: Coordinated Specialty Care (CSC; standard of care)Active Control1 Intervention

Care as usual; no intervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Care Coordination

2016

N/A

~7060

Cognitive Remediation

2010