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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06071858
Other study ID # 2023P002612
Secondary ID 2P50MH115846-05
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date October 2028

Study information

Verified date February 2024
Source Mclean Hospital
Contact Dost Ongur, MD, PhD
Phone 617-855-3922
Email dongur@mgb.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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): 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 350
Est. completion date October 2028
Est. primary completion date October 2028
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Intervention

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.
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.

Locations

Country Name City State
United States McLean Hospital OnTrack Clinic Belmont Massachusetts
United States Boston Medical Center WRAP Boston Massachusetts
United States Massachusetts General Hospital FEPP Clinic Boston Massachusetts
United States Cambridge Health Alliance RISE Clinic Cambridge Massachusetts
United States ServiceNet PREP West Holyoke Massachusetts
United States UMass Memorial Community Healthlink STEP Clinic Worcester Massachusetts

Sponsors (7)

Lead Sponsor Collaborator
Mclean Hospital Boston Medical Center, Cambridge Health Alliance, Massachusetts General Hospital, National Institute of Mental Health (NIMH), ServiceNet, Springfield, University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Exploratory Analysis of symptom and functioning measures in EPINET Core Assessment Battery (CAB) Exploratory analysis of variables collected by EPINET CAB by arm 12 months following clinic intake
Other Proportion of Early Detachment Proportion of patients in each arm who detach from clinic prior to the end of their first month in care 1 month
Other Months Engaged in Care - extension of primary outcome Number of months each participant had =4 visits in a 24-month period 24 months
Primary Months Engaged in Care Number of months each participant had =4 visits in a 12-month period 12 months following clinic intake
Secondary Clinic Visit Number Total number of clinic visits in a 12-month period 12 months following clinic intake
Secondary 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
Secondary Duration of Treatment Duration of time in treatment Up to 12 months - measured as time between clinic intake and detachment
Secondary 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
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