Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2P50MH115846-05 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Boston Medical Center | OTHER |
| Cambridge Health Alliance | OTHER |
| University of Massachusetts, Worcester |
Not provided
Not provided
Not provided
Not provided
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):
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coordinated Specialty Care (CSC; standard of care) | No Intervention | Care as usual; no intervention. | |
| Enhanced Coordinated Speciality Care (CSC 2.0) | Experimental | CSC 2.0 arm will be offered 1:1 peer support, digital outreach, care coordination, multi-family group therapy, and cognitive remediation (if applicable). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care Coordination | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Months Engaged in Care | Number of months each participant had ≥4 visits in a 12-month period | 12 months following clinic intake |
| Measure | Description | Time Frame |
|---|---|---|
| Clinic Visit Number | Total number of clinic visits in a 12-month period | 12 months following clinic intake |
| Clinic Visit Type | Numbers of different types of visits (eer provider, psychotherapy, psychopharmacology, group therapy, etc.) in a 12-month period |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Proportion of Early Detachment |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dost Ongur, MD, PhD | Contact | 617-855-3922 | dongur@mgb.org | |
| Jacqueline Dow, MPH | Contact | 617-855-3321 | jdow@mclean.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dost Ongur, MD, PhD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital OnTrack Clinic | Recruiting | Belmont | Massachusetts | 02478 | United States |
Not provided
| OTHER |
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
|
| Individual Peer Support | Behavioral | • 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 | Behavioral | • 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 | Behavioral |
|
|
| Multi-Family Group Therapy | Behavioral |
|
|
| 12 months following clinic intake |
| Duration of Treatment | Duration of time in treatment | Up to 12 months - measured as time between clinic intake and detachment |
| 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 |
Proportion of patients in each arm who detach from clinic prior to the end of their first month in care
| 1 month |
| Months Engaged in Care - extension of primary outcome | Number of months each participant had ≥4 visits in a 24-month period | 24 months |
| Massachusetts General Hospital FEPP Clinic | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| Boston Medical Center WRAP | Recruiting | Boston | Massachusetts | 02118 | United States |
|
| Cambridge Health Alliance RISE Clinic | Recruiting | Cambridge | Massachusetts | 02139 | United States |
|
| UMass Memorial Community Healthlink STEP Clinic | Recruiting | Worcester | Massachusetts | 01610 | United States |
|
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000072466 | Cognitive Remediation |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided