RecruitingNot ApplicableNCT06071858

Enhanced Coordinated Specialty Care for Early Psychosis

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


Sponsor

Mclean Hospital

Enrollment

350 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Inclusion Criteria7

  • 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 Criteria1

  • None

Interventions

BEHAVIORALCare 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.

BEHAVIORALIndividual 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.

BEHAVIORALDigital 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.

BEHAVIORALCognitive 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.

BEHAVIORALMulti-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.


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

View Full Details on ClinicalTrials.gov

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NCT06071858


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