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NCT Number: NCT06071858

Enhanced Coordinated Specialty Care 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.

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Key information

Conditions

Psychosis Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders Psychosis Nos/Other Psychotic Disorders Schizoaffective Disorder Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McLean Hospital OnTrack Clinic, Belmont, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Care Coordination

Behavioral
  • 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

Behavioral
  • 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

Behavioral
  • 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

Behavioral
  • 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

Behavioral
  • 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 outcomes

  1. Months Engaged in Care

    Time frame: 12 months following clinic intake

    Number of months each participant had ≥4 visits in a 12-month period

Secondary outcomes

  1. Clinic Visit Number

    Time frame: 12 months following clinic intake

    Total number of clinic visits in a 12-month period

  2. Clinic Visit Type

    Time frame: 12 months following clinic intake

    Numbers of different types of visits (eer provider, psychotherapy, psychopharmacology, group therapy, etc.) in a 12-month period

  3. Duration of Treatment

    Time frame: Up to 12 months - measured as time between clinic intake and detachment

    Duration of time in treatment

  4. Proportion in Arm Still in Clinic

    Time frame: 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

Other outcomes

  1. Exploratory Analysis of symptom and functioning measures in EPINET Core Assessment Battery (CAB)

    Time frame: 12 months following clinic intake

    Exploratory analysis of variables collected by EPINET CAB by arm

  2. Proportion of Early Detachment

    Time frame: 1 month

    Proportion of patients in each arm who detach from clinic prior to the end of their first month in care

  3. Months Engaged in Care - extension of primary outcome

    Time frame: 24 months

    Number of months each participant had ≥4 visits in a 24-month period

Study contacts

Contact information is provided by the study sponsor or research team.

Dost Ongur, MD, PhD

CONTACT

[email protected]

617-855-3922

Jacqueline Dow, MPH

CONTACT

[email protected]

617-855-3321

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • Boston Medical Center
  • Cambridge Health Alliance
  • Massachusetts General Hospital
  • National Institute of Mental Health (NIMH)
  • University of Massachusetts, Worcester

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 10, 2023
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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