Enhanced Coordinated Specialty Care for Early Psychosis

Part of paid clinical trials in Belmont, Massachusetts.

Sponsor
Mclean Hospital
Study ID
NCT06071858
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 1, 2024
Status verified
Feb 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

Primary Outcome Measure

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

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
McLean Hospital OnTrack ClinicBelmontMassachusetts02478
Dost Ongur, MD, PhD
Boston Medical Center WRAPBostonMassachusetts02118
Dost Ongur, MD, PhD
Massachusetts General Hospital FEPP ClinicBostonMassachusetts02114
Dost Ongur, MD, PhD
Cambridge Health Alliance RISE ClinicCambridgeMassachusetts02139
Dost Ongur, MD, PhD
UMass Memorial Community Healthlink STEP ClinicWorcesterMassachusetts01610
Dost Ongur, MD, PhD

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McLean Hospital OnTrack Clinic· Belmont, MABoston Medical Center WRAP· Boston, MAMassachusetts General Hospital FEPP Clinic· Boston, MACambridge Health Alliance RISE Clinic· Cambridge, MAUMass Memorial Community Healthlink STEP Clinic· Worcester, MA

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