Status:
RECRUITING
Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans
Lead Sponsor:
VA Office of Research and Development
Conditions:
Post Traumatic Stress Disorder (PTSD)
Depression
Eligibility:
All Genders
18+ years
Phase:
NA
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 th...
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 popul...
Eligibility Criteria
Inclusion
- To be eligible, participants must be:
- enrolled in VA primary care through the local VA site
- report clinically significant psychological distress as measured in at least one of three areas:
- PTSD operationalized by 30 on the PCL-5 plus endorsing a criteria A stressor
- depression operationalized as 10 on the PHQ-9
- anxiety operationalized by 10 on the GAD-7
Exclusion
- Exclusion criteria are minimized to allow inclusion of any primary care patients with psychological distress that would normally receive treatment in primary care. Patients will be excluded if they demonstrate symptoms that would not allow them to actively participate in the interventions:
- gross cognitive impairment
- suicide attempt or desire to commit suicide in the last month
- To allow the study to isolate the effects of the intervention and ensure patient treatment preferences are honored, patients will be excluded if they:
- had a psychotherapy appointment outside of primary care within the last month and have future appointment scheduled
- had a change in psychiatric medication outside of VHA primary care in the last 2 months
- voice a preference to be directly referred to specialty mental health care
- Veterans with mild TBI, and alcohol/ substance use disorders will not be excluded because these problems commonly co-occur with psychological distress, and individuals with these conditions have previously benefited from mindfulness and problem-solving training. Patients who receive Primary Care Mental Health Integration (PCMHI) services will not be excluded as this is part of the usual primary care services that all Veterans receive.
Key Trial Info
Start Date :
August 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06162741
Start Date
August 19 2024
End Date
December 31 2027
Last Update
July 30 2025
Active Locations (4)
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1
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States, 85012
2
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161-0002
3
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, United States, 63106-1621
4
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, United States, 13210-2716