Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162741
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2023-11-29
Brief Title:
Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans
Status:
RECRUITING
Status Verified Date:
2024-08
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 VA wants to understand what type of integrative and whole health approaches are helpful for Veterans The study is comparing two primary care based mental health treatments a mindfulness class that teaches mindfulness meditation and a problem-solving class that teaches problem-solving skills and how to build resilience for Veterans who are experiencing symptoms of anxiety depression andor PTSD The goal of the study is to understand if the classes reduce symptoms of anxiety depression andor PTSD and increase overall functioning
Detailed Description:
This study seeks to further test the effectiveness of Primary Care Brief Mindfulness Training PCBMT across multiple geographically distinct VHA primary care settings that serve diverse Veteran populations and begin to understand important implementation factors with a hybrid type I randomized controlled trial in 300 primary care patients with psychological distress The study aims include comparing PCBMT to a transdiagnostic problem solving group Moving Forward MF on clinical outcomes testing mediators and moderators of treatment gain in PCBMT and MF and assessing implementation barriers and facilitators to inform future implementation efforts The investigators hypothesize that Veterans randomized to PCBMT will experience larger decreases in psychological distress than participants randomized to MF and changes in transdiagnostic processes will mediate the relationship between changes in mindfulness and psychological distress
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1I01HX003626-01A2 | NIH | Health Services Research Development HSRD | httpsreporternihgovquickSearch1I01HX003626-01A2 |