Enhanced Coordinated Specialty Care for Early Psychosis

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06071858
• Other study ID #: 2023P002612
• Secondary ID: 2P50MH115846-05
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Bipolar Disorder
• Mental Disorders
• Psychosis
• Psychosis Nos/Other
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

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