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Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans

NCT06162741 · VA Office of Research and Development
In plain English

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About this study
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.
Eligibility 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.
Study design
Enrollment target: 300 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-08-19
Estimated completion: 2027-12-31
Last updated: 2025-07-30
Interventions
Behavioral: Primary Care Brief Mindfulness Training (PCBMT)Behavioral: Moving Forward (MF)
Primary outcomes
  • Depression Anxiety and Stress Scale (DASS-21) Change (Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks)
Sponsor
VA Office of Research and Development · fed
Contacts & investigators
ContactKyle Possemato, PhD · contact · kyle.possemato@va.gov · (315) 425-4400
ContactAriella Davis · contact · Ariella.Davis@va.gov
InvestigatorKyle Possemato, PhD · principal_investigator, Syracuse VA Medical Center, Syracuse, NY
All locations (4)
Phoenix VA Health Care System, Phoenix, AZRecruiting
Phoenix, Arizona, United States
VA San Diego Healthcare System, San Diego, CARecruiting
San Diego, California, United States
St. Louis VA Medical Center John Cochran Division, St. Louis, MORecruiting
St Louis, Missouri, United States
Syracuse VA Medical Center, Syracuse, NYActive Not Recruiting
Syracuse, New York, United States
Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans · TrialPath