Mindfulness training for Veterans with PTSD, depression, and anxiety
Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans
This study is testing whether mindfulness training can help Veterans with PTSD, depression, and anxiety feel better compared to a regular problem-solving class.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 4 sites (Phoenix, Arizona and 3 other locations) |
| Trial ID | NCT06162741 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Primary Care Brief Mindfulness Training (PCBMT) compared to a problem-solving class for Veterans experiencing psychological distress. It involves a hybrid type I randomized controlled trial across multiple VA primary care settings, aiming to assess clinical outcomes and implementation factors. The study will include 300 participants and measure changes in symptoms of PTSD, depression, and anxiety, as well as overall functioning. The goal is to determine if mindfulness training leads to greater reductions in psychological distress than traditional problem-solving approaches.
Who should consider this trial
Good fit: Ideal candidates are Veterans enrolled in VA primary care who report clinically significant psychological distress related to PTSD, depression, or anxiety.
Not a fit: Patients with gross cognitive impairment or recent suicidal ideation may not benefit from this study due to their inability to actively participate in the interventions.
Why it matters
Potential benefit: If successful, this study could provide Veterans with effective, accessible mental health interventions that significantly reduce symptoms of PTSD, depression, and anxiety.
How similar studies have performed: Other studies have shown promise in using mindfulness-based interventions for mental health issues, suggesting that this approach could be effective for Veterans as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: 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.
Where this trial is running
Phoenix, Arizona and 3 other locations
- Phoenix VA Health Care System, Phoenix, AZ — Phoenix, Arizona, United States (Recruiting)
- VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States (Recruiting)
- St. Louis VA Medical Center John Cochran Division, St. Louis, MO — St Louis, Missouri, United States (Recruiting)
- Syracuse VA Medical Center, Syracuse, NY — Syracuse, New York, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Kyle Possemato, PhD — Syracuse VA Medical Center, Syracuse, NY
- Study coordinator: Kyle Possemato, PhD
- Email: kyle.possemato@va.gov
- Phone: (315) 425-4400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.