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

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…

ClinicalTrials.gov IDNCT06162741

PhaseNA

Enrollment300

SponsorVA Office of Research and Development

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Post Traumatic Stress Disorder (PTSD), Depression, Anxiety

About this study

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.

Primary outcomes

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

Eligibility information

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 locations

Phoenix VA Health Care System, Phoenix, AZ, Phoenix, Arizona 85012 United States
VA San Diego Healthcare System, San Diego, CA, San Diego, California 92161-0002 United States
St. Louis VA Medical Center John Cochran Division, St. Louis, MO, St Louis, Missouri 63106-1621 United States
Syracuse VA Medical Center, Syracuse, NY, Syracuse, New York 13210-2716 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.