NCT06071858 · Mclean Hospital
Enhanced Coordinated Specialty Care for Early Psychosis
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Months Engaged in Care
Time frame: 12 months following clinic intake
Number of months each participant had ≥4 visits in a 12-month period
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Belmont, Massachusetts
- Boston, Massachusetts
- Cambridge, Massachusetts
- Worcester, Massachusetts
Collaborators
Massachusetts General Hospital, Boston Medical Center, Cambridge Health Alliance, University of Massachusetts, Worcester, National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations