Brief Summary

The goal of this clinical trial is to compare engagement in treatment in coordinated specialty care (CSC) to five extra care elements (CSC 2.0) in first-episode psychosis. The main question it aims to answer is:

Does the addition of certain elements of care increase the number of visits in treatment for first-episode psychosis? Participants will either:
Receive care as usual (CSC) or
Receive care as usual (CSC) plus five additional care elements (CSC 2.0):
Individual peer support
Digital outreach
Care coordination
Multi-family group therapy
Cognitive remediation

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

350

participants targeted

Target at P75+ for not_applicable

Timeline

29mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach

1 country

5 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.7 years study duration

Study Progress49%

Feb 2024Oct 2028

First Submitted

Initial submission to the registry

September 26, 2023

Completed

14 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed

4 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed

4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

4.7 years

First QC Date

September 26, 2023

Last Update Submit

February 25, 2026

Conditions

Psychosis Schizophrenia Schizoaffective Disorder Psychosis Nos/Other Bipolar Disorder

Keywords

first episode psychosisearly psychosis

Outcome Measures

Primary Outcomes (1)

Months Engaged in Care
Number of months each participant had ≥4 visits in a 12-month period
12 months following clinic intake

Secondary Outcomes (4)

Clinic Visit Number
12 months following clinic intake
Clinic Visit Type
12 months following clinic intake
Duration of Treatment
Up to 12 months - measured as time between clinic intake and detachment
Proportion in Arm Still in Clinic
12 months following clinic intake

Other Outcomes (3)

Exploratory Analysis of symptom and functioning measures in EPINET Core Assessment Battery (CAB)
12 months following clinic intake
Proportion of Early Detachment
1 month
Months Engaged in Care - extension of primary outcome
24 months

Study Arms (2)

Coordinated Specialty Care (CSC; standard of care)

NO INTERVENTION

Care as usual; no intervention.

Enhanced Coordinated Speciality Care (CSC 2.0)

EXPERIMENTAL

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

Behavioral: Care CoordinationBehavioral: Individual Peer SupportBehavioral: Digital OutreachBehavioral: Cognitive RemediationBehavioral: Multi-Family Group Therapy

Interventions

Care CoordinationBEHAVIORAL

* The study staff clinician will review all medical issues for each patient and reach out to primary care providers (PCP), dieticians, and other medical providers as needed. * The study staff clinician will serve as point person for communication with emergency departments and inpatient providers if the patient requires those levels of care. * The clinician will communicate with outside providers to provide background and ensure health decision making by those providers, visit and support patients as appropriate, access outside records and share with rest of the care team, and most critically ensure that a proper discharge plan has been made for the patient including care appointments, access to prescriptions and any new referrals made during hospitalization.