Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT06071858
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2023-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enhanced Coordinated Specialty Care for Early Psychosis
Sponsor:
Mclean Hospital
Organization:
Study Overview
Official Title:
Cluster Randomized Trial of Enhanced Coordinated Specialty Care (CSC 2.0) for Early Psychosis
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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):
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.
• 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2P50MH115846-05 | NIH | None | https://reporter.nih.gov/quic… | View |