Purpose

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

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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).
  • 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.

Recruiting Locations

Massachusetts General Hospital FEPP Clinic
Boston, Massachusetts 02114
Contact:
Dost Ongur, MD, PhD

More Details

Status
Recruiting
Sponsor
Mclean Hospital

Study Contact

Dost Ongur, MD, PhD
617-855-3922
dongur@mgb.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.