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

Overview

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.

Interventions

• Behavioral Primary Care Brief Mindfulness Training (PCBMT)
  PCBMT is a manualized intervention that is a brief adaptation of MBSR Mindfulness Based Stress Reduction (MBSR). It was developed by Dr. Scott Treatman and Dr. Dessa Bergen-Cico (Co-I). PCBMT consists of four 90-minute classes (360 total minutes of classes). 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. In-class meditations are followed by a grou
• Behavioral 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". The format that will be used as the comparison is manualized, group-delivered, primary care-based, often co-delivered by MH providers and peers, and considered a usual care practice in many VHA PCMHI programs. MF content is derived from problem solving therapy, which has clear effectiveness in reducin

Primary outcome measures

• Depression Anxiety and Stress Scale (DASS-21) Change [Time frame: Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks]

Secondary outcome measures (2)

• Satisfaction with Life Scale (SWLS) [Time frame: Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks]
• PTSD Checklist for DSM-5 (PCL-5) [Time frame: Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 4 centers

• Phoenix VA Health Care System, Phoenix, AZ — Phoenix
• VA San Diego Healthcare System, San Diego, CA — San Diego
• St. Louis VA Medical Center John Cochran Division, St. Louis, MO — St Louis
• Syracuse VA Medical Center, Syracuse, NY — Syracuse

Identifiers

NCT: NCT06162741 · IIR 22-013 · 1I01HX003626-01A2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗