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RECRUITING
NCT06162741
NA

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

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2024-08-19

Completion Date

2027-12-31

Last Updated

2025-07-30

Healthy Volunteers

No

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 group process of the experience. At-home practice between sessions is encouraged and is guided by simple checklists asking students to check the meditation they practiced and write a few comments about what the experience was like.

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 reducing depression and other types of psychological distress. While the MF manual consists of four 60-minutes classes, for this study the 4 classes will be 90-minutes long to equate the length of both conditions. No new content will be added rather the additional time will be used to allow Veterans to complete worksheets in class and allow more group discussion.

Locations (4)

Phoenix VA Health Care System, Phoenix, AZ

Phoenix, Arizona, United States

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

St. Louis VA Medical Center John Cochran Division, St. Louis, MO

St Louis, Missouri, United States

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, United States