Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans
Sponsored by VA Office of Research and Development
About this study
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, and/or PTSD. The goal of the study is to understand if the classes reduce symptoms of anxiety, depression, and/or PTSD and increase overall functioning.
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…
Where this study is enrolling (3)
- I'm interested
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona
- I'm interested
VA San Diego Healthcare System, San Diego, CA
San Diego, California
- I'm interested
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri
Who can participate
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.
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.