Enhanced Coordinated Specialty Care for Early Psychosis
NCT ID: NCT06071858
Last Updated: 2025-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
350 participants
INTERVENTIONAL
2024-02-01
2028-10-31
Brief Summary
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• 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Coordinated Specialty Care (CSC; standard of care)
Care as usual; no intervention.
No interventions assigned to this group
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).
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Mclean Hospital
OTHER
Massachusetts General Hospital
OTHER
Boston Medical Center
OTHER
Cambridge Health Alliance
OTHER
University of Massachusetts, Worcester
OTHER
National Institute of Mental Health (NIMH)
NIH
Responsible Party
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Dost Ongur
Director, LEAP Center
Principal Investigators
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Dost Ongur, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mclean Hospital
Locations
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McLean Hospital OnTrack Clinic
Belmont, Massachusetts, United States
Massachusetts General Hospital FEPP Clinic
Boston, Massachusetts, United States
Boston Medical Center WRAP
Boston, Massachusetts, United States
Cambridge Health Alliance RISE Clinic
Cambridge, Massachusetts, United States
UMass Memorial Community Healthlink STEP Clinic
Worcester, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Dost Ongur, MD, PhD
Role: primary
Dost Ongur, MD, PhD
Role: primary
Dost Ongur, MD, PhD
Role: primary
Dost Ongur, MD, PhD
Role: primary
Dost Ongur, MD, PhD
Role: primary
Other Identifiers
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2023P002612
Identifier Type: -
Identifier Source: org_study_id
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