Enhanced Coordinated Specialty Care for Early Psychosis

Study Overview
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Brief Summary
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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): Individual peer support Digital outreach Care coordination Multi-family group therapy 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.

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

Conditions
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Psychosis, Schizophrenia, Schizoaffective Disorder, Psychosis Nos/Other, Bipolar Disorder

Intervention / Treatment
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* Behavioral: Care Coordination
* Behavioral: Individual Peer Support
* Behavioral: Digital Outreach
* Behavioral: Cognitive Remediation
* Behavioral: Multi-Family Group Therapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Coordinated Specialty Care (CSC; standard of care)<br>Care as usual; no intervention. | |
| Experimental: Enhanced Coordinated Speciality Care (CSC 2.0)<br>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<br>* 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.<br>Behavioral: Individual Peer Support<br>* • 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.<br>Behavioral: Digital Outreach<br>* • 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.<br>Behavioral: Cognitive Remediation<br>* 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.<br>Behavioral: Multi-Family Group Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Months Engaged in Care | Number of months each participant had ≥4 visits in a 12-month period | 12 months following clinic intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinic Visit Number | Total number of clinic visits in a 12-month period | 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 | 12 months following clinic intake | 
| Duration of Treatment | Duration of time in treatment | 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 | 12 months following clinic intake | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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first episode psychosis, early psychosis