Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans
- Conditions
- Post Traumatic Stress Disorder (PTSD)DepressionAnxiety
- Interventions
- Behavioral: Primary Care Brief Mindfulness Training (PCBMT)Behavioral: Moving Forward (MF)
- Registration Number
- NCT06162741
- Lead Sponsor
- VA Office of Research and Development
- 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, 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
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 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Primary Care Brief Mindfulness Training (PCBMT) Primary Care Brief Mindfulness Training (PCBMT) PCBMT is a manualized intervention that is a brief adaptation of MBSR Mindfulness Based Stress Reduction (MBSR). Instruction encompasses sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go. Moving Forward (MF) Moving Forward (MF) Moving Forward (MF) is a transdiagnostic class that seeks to build resilience and reduce emotional distress by teaching step-by-step problem-solving skills such as "stop, slow down, think and act".
- Primary Outcome Measures
Name Time Method Depression Anxiety and Stress Scale (DASS-21) Change Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks The Depression Anxiety and Stress Scale (DASS-21) is a widely used measurement for psychological symptoms and distress. It consists of 21 items measured on a 4-point scale. The three subscale scores for depression, anxiety, and stress are also valid measures of their constructs and will be used as secondary outcomes. Depression subscale range: 0-42 with higher scores meaning a worse outcome. Anxiety subscale range: 0-42 with higher scores meaning a worse outcome. Stress subscale range 0-21 with higher scores indicative of greater symptom severity.
- Secondary Outcome Measures
Name Time Method Satisfaction with Life Scale (SWLS) Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks Satisfaction with Life Scale (SWLS) is a 5-item scale measuring global judgements of life satisfaction. The possible range of scores is 5-35, with a score of 20 representing a neutral point on the scale. Scores between 5-9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31-35 indicate the respondent is extremely satisfied.
PTSD Checklist for DSM-5 (PCL-5) Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. PTSD Checklist-5 scale range 0-63 with 63 indicating highest PTSD severity.
Trial Locations
- Locations (3)
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
🇺🇸Saint Louis, Missouri, United States
Syracuse VA Medical Center, Syracuse, NY
🇺🇸Syracuse, New York, United States
Phoenix VA Health Care System, Phoenix, AZ
🇺🇸Phoenix, Arizona, United States