Enhanced Coordinated Specialty Care for Early Psychosis

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

Interventions

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.

Sponsors & Collaborators

• Massachusetts General Hospital

  collaborator OTHER

• Boston Medical Center

  collaborator OTHER

• Cambridge Health Alliance

  collaborator OTHER

• University of Massachusetts, Worcester

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Mclean Hospital

  lead OTHER

Principal Investigators

• Dost Ongur, MD, PhD · Mclean Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-01

Primary Completion

2028-10-31

Completion

2028-10-31

Countries

• United States

Study Locations