Enhanced Coordinated Specialty Care for Early Psychosis

Not Applicable

Recruiting

• Conditions: Psychosis; Schizophrenia; Psychosis Nos/Other; Bipolar Disorder; Schizoaffective Disorder
• Interventions: Behavioral: Care Coordination; Behavioral: Individual Peer Support; Behavioral: Digital Outreach; Behavioral: Cognitive Remediation; Behavioral: Multi-Family Group Therapy

• Registration Number: NCT06071858
• Lead Sponsor: Mclean Hospital

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):

1. Individual peer support

2. Digital outreach

3. Care coordination

4. Multi-family group therapy

5. Cognitive remediation

Researchers will compare the standard of care (CSC) to CSC 2.0 to see if participants receiving CSC 2.0 have more visits to their clinic in their first year.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-26
• Study First Submitted QC: 2023-10-03
• Study First Posted: 2023-10-10
• Study Start: 2024-02-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Primary Completion: 2028-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• People undergoing an intake evaluation to CSC for first-episode psychosis in one of the following outpatient clinics:
• McLean Hospital OnTrack (OnTrack Clinic)
• Massachusetts General Hospital (FEPP Clinic)
• Boston Medical Center (WRAP Clinic)
• Cambridge Health Alliance (RISE Clinic)
• UMass Memorial Health Care (STEP Clinic)
• ServiceNet (PREP West)

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Coordinated Speciality Care (CSC 2.0)	Digital Outreach	CSC 2.0 arm will be offered 1:1 peer support, digital outreach, care coordination, multi-family group therapy, and cognitive remediation (if applicable).
Enhanced Coordinated Speciality Care (CSC 2.0)	Cognitive Remediation	CSC 2.0 arm will be offered 1:1 peer support, digital outreach, care coordination, multi-family group therapy, and cognitive remediation (if applicable).
Enhanced Coordinated Speciality Care (CSC 2.0)	Care Coordination	CSC 2.0 arm will be offered 1:1 peer support, digital outreach, care coordination, multi-family group therapy, and cognitive remediation (if applicable).
Enhanced Coordinated Speciality Care (CSC 2.0)	Individual Peer Support	CSC 2.0 arm will be offered 1:1 peer support, digital outreach, care coordination, multi-family group therapy, and cognitive remediation (if applicable).
Enhanced Coordinated Speciality Care (CSC 2.0)	Multi-Family Group Therapy	CSC 2.0 arm will be offered 1:1 peer support, digital outreach, care coordination, multi-family group therapy, and cognitive remediation (if applicable).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Duration of Treatment	Up to 12 months - measured as time between clinic intake and detachment	Duration of time in treatment
Clinic Visit Number	12 months following clinic intake	Total number of clinic visits in a 12-month period
Proportion in Arm Still in Clinic	12 months following clinic intake	Proportion of patients in each arm who are still in CSC at the end of the 12-month follow-up period
Clinic Visit Type	12 months following clinic intake	Numbers of different types of visits (eer provider, psychotherapy, psychopharmacology, group therapy, etc.) in a 12-month period

Trial Locations

Locations (5)

McLean Hospital OnTrack Clinic; 🇺🇸 Belmont, Massachusetts, United States

Massachusetts General Hospital FEPP Clinic; 🇺🇸 Boston, Massachusetts, United States

Boston Medical Center WRAP; 🇺🇸 Boston, Massachusetts, United States

Cambridge Health Alliance RISE Clinic; 🇺🇸 Cambridge, Massachusetts, United States

UMass Memorial Community Healthlink STEP Clinic; 🇺🇸 Worcester, Massachusetts, United States