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Enhanced Coordinated Specialty Care for Early Psychosis

Primary Purpose

Psychosis, Schizophrenia, Schizoaffective Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Care Coordination
Individual Peer Support
Digital Outreach
Cognitive Remediation
Multi-Family Group Therapy
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring first episode psychosis, early psychosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Coordinated Specialty Care (CSC; standard of care)

    Enhanced Coordinated Speciality Care (CSC 2.0)

    Arm Description

    Care as usual; no intervention.

    CSC 2.0 arm will be offered 1:1 peer support, digital outreach, care coordination, multi-family group therapy, and cognitive remediation (if applicable).

    Outcomes

    Primary Outcome Measures

    Months Engaged in Care
    Number of months each participant had ≥4 visits in a 12-month period

    Secondary Outcome Measures

    Clinic Visit Number
    Total number of clinic visits in a 12-month period
    Clinic Visit Type
    Numbers of different types of visits (eer provider, psychotherapy, psychopharmacology, group therapy, etc.) in a 12-month period
    Duration of Treatment
    Duration of time in treatment
    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

    Full Information

    First Posted
    September 26, 2023
    Last Updated
    October 6, 2023
    Sponsor
    Mclean Hospital
    Collaborators
    Massachusetts General Hospital, Boston Medical Center, Cambridge Health Alliance, University of Massachusetts, Worcester, National Institute of Mental Health (NIMH), ServiceNet, Springfield
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06071858
    Brief Title
    Enhanced Coordinated Specialty Care for Early Psychosis
    Official Title
    Cluster Randomized Trial of Enhanced Coordinated Specialty Care (CSC 2.0) for Early Psychosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2028 (Anticipated)
    Study Completion Date
    October 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mclean Hospital
    Collaborators
    Massachusetts General Hospital, Boston Medical Center, Cambridge Health Alliance, University of Massachusetts, Worcester, National Institute of Mental Health (NIMH), ServiceNet, Springfield

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychosis, Schizophrenia, Schizoaffective Disorder, Psychosis Nos/Other, Bipolar Disorder
    Keywords
    first episode psychosis, early psychosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    350 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Coordinated Specialty Care (CSC; standard of care)
    Arm Type
    No Intervention
    Arm Description
    Care as usual; no intervention.
    Arm Title
    Enhanced Coordinated Speciality Care (CSC 2.0)
    Arm Type
    Experimental
    Arm Description
    CSC 2.0 arm will be offered 1:1 peer support, digital outreach, care coordination, multi-family group therapy, and cognitive remediation (if applicable).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Care Coordination
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Individual Peer Support
    Intervention Description
    • 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Digital Outreach
    Intervention Description
    • 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Remediation
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Multi-Family Group Therapy
    Intervention Description
    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 Measure Information:
    Title
    Months Engaged in Care
    Description
    Number of months each participant had ≥4 visits in a 12-month period
    Time Frame
    12 months following clinic intake
    Secondary Outcome Measure Information:
    Title
    Clinic Visit Number
    Description
    Total number of clinic visits in a 12-month period
    Time Frame
    12 months following clinic intake
    Title
    Clinic Visit Type
    Description
    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
    Title
    Duration of Treatment
    Description
    Duration of time in treatment
    Time Frame
    Up to 12 months - measured as time between clinic intake and detachment
    Title
    Proportion in Arm Still in Clinic
    Description
    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
    Other Pre-specified Outcome Measures:
    Title
    Exploratory Analysis of symptom and functioning measures in EPINET Core Assessment Battery (CAB)
    Description
    Exploratory analysis of variables collected by EPINET CAB by arm
    Time Frame
    12 months following clinic intake
    Title
    Proportion of Early Detachment
    Description
    Proportion of patients in each arm who detach from clinic prior to the end of their first month in care
    Time Frame
    1 month
    Title
    Months Engaged in Care - extension of primary outcome
    Description
    Number of months each participant had ≥4 visits in a 24-month period
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dost Ongur, MD, PhD
    Phone
    617-855-3922
    Email
    dongur@mgb.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jacqueline Dow, MPH
    Phone
    617-855-3321
    Email
    jdow@mclean.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dost Ongur, MD, PhD
    Organizational Affiliation
    Mclean Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Enhanced Coordinated Specialty Care for Early Psychosis

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