Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620900
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Expanding Access to mTBI Treatment for Veterans and Service Members With Co-occurring Substance Use
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Expanding Access to mTBI Treatment for Veterans and Service Members With Co-occurring Substance Use
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ExpandAccess
Brief Summary:
The purpose of this research is to determine whether military veterans and service members with mild traumatic brain injury with and without co-occurring substance use can complete and benefit from integrated interdisciplinary care individualized to their symptoms goals and needs
Participants will complete surveys about substance use and other symptoms at the beginning and end of treatment in an intensive outpatient program and 6 months after discharge
Participants will complete surveys about substance use and other symptoms at the beginning and end of treatment in an intensive outpatient program and 6 months after discharge
Detailed Description:
This pragmatic clinical trial will 1 assess treatment retention and treatment outcomes at the completion of interdisciplinary intensive outpatient program IOP and at a 6-month follow-up comparing service members and veterans SMVs with mild traumatic brain injury mTBI substance use SU and a TBI -control group and 2 assess SU-related outcomes at the end of IOP treatment and durability of SU outcomes at 6-months follow-up among SMVs with co-occurring SU Analyses of these key treatment outcomes along with input from lived experience consultants and other key stakeholders will be used to refine and disseminate a scalable approach to treating individuals with mTBI and co-occurring SU
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None