Recruiting

Coordinated Specialty Care

Sponsor:

Mclean Hospital

Code:

NCT06071858

Conditions

Psychosis

Schizophrenia

Schizoaffective Disorder

Psychosis Nos/Other

Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Care Coordination

Individual Peer Support

Digital Outreach

Cognitive Remediation

Multi-Family Group Therapy

Study Details

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.

Conditions

Psychosis

Schizophrenia

Schizoaffective Disorder

Psychosis Nos/Other

Bipolar Disorder

Study ID

NCT06071858

Start date

Feb 1, 2024

Status verified date

Feb, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

Interventions

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.

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.

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.

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.

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.

Primary outcome measure

  • Months Engaged in Care [ Time Frame: 12 months following clinic intake ]

Central Contacts and Locations

Central contacts

Dost Ongur, MD, PhD

617-855-3922dongur@mgb.org

Jacqueline Dow, MPH

617-855-3321jdow@mclean.harvard.edu

Locations

McLean Hospital OnTrack Clinic

Recruiting

Belmont, Massachusetts, United States, 02478

Massachusetts General Hospital FEPP Clinic

Recruiting

Boston, Massachusetts, United States, 02114

Boston Medical Center WRAP

Recruiting

Boston, Massachusetts, United States, 02118

Cambridge Health Alliance RISE Clinic

Recruiting

Cambridge, Massachusetts, United States, 02139

UMass Memorial Community Healthlink STEP Clinic

Recruiting

Worcester, Massachusetts, United States, 01610

More Information

Sponsor

Mclean Hospital

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • first episode psychosis
  • early psychosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2026-02-27.