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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
350
* 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.
• 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.
• 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.
* 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.
* 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.
McLean Hospital OnTrack Clinic
Belmont, Massachusetts, United States
RECRUITINGMassachusetts General Hospital FEPP Clinic
Boston, Massachusetts, United States
RECRUITINGBoston Medical Center WRAP
Boston, Massachusetts, United States
RECRUITINGCambridge Health Alliance RISE Clinic
Cambridge, Massachusetts, United States
RECRUITINGUMass Memorial Community Healthlink STEP Clinic
Worcester, Massachusetts, United States
RECRUITINGMonths Engaged in Care
Number of months each participant had ≥4 visits in a 12-month period
Time frame: 12 months following clinic intake
Clinic Visit Number
Total number of clinic visits in a 12-month period
Time frame: 12 months following clinic intake
Clinic Visit Type
Numbers of different types of visits (eer provider, psychotherapy, psychopharmacology, group therapy, etc.) in a 12-month period
Time frame: 12 months following clinic intake
Duration of Treatment
Duration of time in treatment
Time frame: Up to 12 months - measured as time between clinic intake and detachment
Proportion in Arm Still in Clinic
Proportion of patients in each arm who are still in CSC at the end of the 12-month follow-up period
Time frame: 12 months following clinic intake
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