Enhanced Coordinated Specialty Care for Early Psychosis

Cluster Randomized Trial of Enhanced Coordinated Specialty Care (CSC 2.0) for Early Psychosis

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dost Ongur, MD, PhD; Phone Number: 617-855-3922; Email: dongur@mgb.org
• Study Contact Backup: Name: Jacqueline Dow, MPH; Phone Number: 617-855-3321; Email: jdow@mclean.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • Recruiting
      • McLean Hospital OnTrack Clinic
      • Contact: Dost Ongur, MD, PhD
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital FEPP Clinic
      • Contact: Dost Ongur, MD, PhD
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Medical Center WRAP
      • Contact: Dost Ongur, MD, PhD
    • Cambridge, Massachusetts, United States, 02139
      • Recruiting
      • Cambridge Health Alliance RISE Clinic
      • Contact: Dost Ongur, MD, PhD
    • Worcester, Massachusetts, United States, 01610
      • Recruiting
      • UMass Memorial Community Healthlink STEP Clinic
      • Contact: Dost Ongur, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Coordinated Specialty Care (CSC; standard of care); Care as usual; no intervention.
Experimental: Enhanced Coordinated Speciality Care (CSC 2.0); 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 Coordination; 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.; Behavioral: Individual Peer Support; • Patients will be offered weekly 1:1 sessions with a Peer Provider as part of routine care in a mixture of in-person and virtual formats as appropriate to support patients around treatment decisions, and recovery.; Behavioral: Digital Outreach; • mindLAMP smartphone application for various kinds of outreach including but not limited to medication and/or appointment reminders, resources, and activities such as breathing and meditation exercises.; Behavioral: Cognitive Remediation; For participants identified as needing and/or wanting support around cognition.; The cognitive remediation program is available online or in-app and offers memory, attention, processing speed, executive functioning, and social cognition training activities.; Behavioral: Multi-Family Group Therapy; Families whose loved ones are in CSC clinic will be offered weekly group sessions with a study staff clinician.; Each group may include 5-8 families and include a mixture of in-person and virtual formats.; These groups will be open-ended, including psychoeducation, and practical problem-solving discussions around care and other topics.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Analysis of symptom and functioning measures in EPINET Core Assessment Battery (CAB)	Exploratory analysis of variables collected by EPINET CAB by arm	12 months following clinic intake
Proportion of Early Detachment	Proportion of patients in each arm who detach from clinic prior to the end of their first month in care	1 month
Months Engaged in Care - extension of primary outcome	Number of months each participant had ≥4 visits in a 24-month period	24 months

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Collaborators: National Institute of Mental Health (NIMH); Massachusetts General Hospital; Boston Medical Center; University of Massachusetts, Worcester; Cambridge Health Alliance
• Investigators: Principal Investigator: Dost Ongur, MD, PhD, McLean Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: early psychosis; first episode psychosis
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Mood Disorders; Schizophrenia; Psychotic Disorders; Bipolar Disorder; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Remediation
• Other Study ID Numbers: 2023P002612; 2P50MH115846-05 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No