Mindfulness training for Veterans with PTSD, depression, and anxiety

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of Primary Care Brief Mindfulness Training (PCBMT) compared to a problem-solving class for Veterans experiencing psychological distress. It involves a hybrid type I randomized controlled trial across multiple VA primary care settings, aiming to assess clinical outcomes and implementation factors. The study will include 300 participants and measure changes in symptoms of PTSD, depression, and anxiety, as well as overall functioning. The goal is to determine if mindfulness training leads to greater reductions in psychological distress than traditional problem-solving approaches.

Why it matters

Who can join: the full rules

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.

Where it's running

• Phoenix VA Health Care System, Phoenix, AZ
  Phoenix, Arizona, United States Recruiting
• VA San Diego Healthcare System, San Diego, CA
  San Diego, California, United States Recruiting
• St. Louis VA Medical Center John Cochran Division, St. Louis, MO
  St Louis, Missouri, United States Recruiting
• Syracuse VA Medical Center, Syracuse, NY
  Syracuse, New York, United States Active not recruiting

Study contacts

• Principal investigator: Kyle Possemato, PhD — Syracuse VA Medical Center, Syracuse, NY
• Study coordinator: Kyle Possemato, PhD
• Email: kyle.possemato@va.gov
• Phone: (315) 425-4400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.