Primary care brief mindfulness training for veterans with psychological distress: Protocol for a hybrid type I effectiveness-implementation randomized controlled trial.
Dessa Bergen-Cico, A. Ramon, Benjamin I. Felleman, Kyle Possemato
Contemporary Clinical Trials August 1, 2026 DOI: 10.1016/j.cct.2026.108451 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial (protocol) Qualitative Peer reviewed |
|---|---|
| Sample size | 300 |
| Population | Veterans receiving VHA primary care with clinically significant psychological distress |
| Interventions | Primary Care Brief Mindfulness Training (PCBMT) Moving Forward (MF) |
| Duration | 8-week intervention |
| Measures | Depression Anxiety and Stress Scale (DASS-21) |
| Topics | Meditation |
| Key findings | This protocol describes an ongoing trial; no results are reported. Preliminary RCTs indicated that PCBMT reduced PTSD and depression severity relative to control conditions. |
Abstract
Psychological distress, encompassing PTSD, depression, and anxiety-is highly prevalent among Veterans receiving care in Veterans Health Administration (VHA) primary care settings, yet it frequently goes untreated or undertreated. Traditional psychotherapies and psychiatric medications are often misaligned with Veterans' preferences for self-reliance, low-stigma formats, and skill-based approaches. Primary Care Brief Mindfulness Training (PCBMT) was developed as a brief, transdiagnostic, group-based mindfulness intervention co-facilitated by licensed mental health providers and Veteran peer specialists in VHA primary care. Two preliminary randomized controlled trials (RCTs) demonstrated reductions in PTSD and depression severity relative to control conditions. An ongoing study extends this work through a Hybrid Type I effectiveness-implementation trial at three geographically and demographically diverse VHA sites (Phoenix, San Diego, St. Louis). Three hundred primary care patients with clinically significant psychological distress are being randomized 1:1 to PCBMT or Moving Forward (MF), a transdiagnostic problem-solving group that serves as an active comparison condition. The primary outcome is change in total psychological distress as measured by the Depression Anxiety and Stress Scale (DASS-21) from baseline to post-intervention (8 weeks). Secondary aims will test transdiagnostic mediators (mindfulness, emotion regulation, psychological flexibility, thought suppression) and explore social determinants of health (SDOH) as potential moderators of initiation, completion, and clinical benefit. A qualitative implementation aim, guided by the Consolidated Framework for Implementation Research (CFIR), will characterize barriers and facilitators to support future scale-up. This protocol describes participant selection criteria, intervention conditions, facilitator training, outcome measurement, and analytic strategy. Trial Registration:ClinicalTrials.gov Identifier: NCT-06162741.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 6
- Using Self-Report Assessment Methods to Explore Facets of Mindfulness Assessment January 27, 2006
- Effects of Mindfulness-Based Stress Reduction Intervention on Psychological Well-being and Quality of Life: Is Increased Mindfulness Indeed the Mechanism? Annals of Behavioral Medicine June 1, 2008
- Association of participation in a mindfulness programme with bowel symptoms, gastrointestinal symptom‐specific anxiety and quality of life Alimentary Pharmacology & Therapeutics June 9, 2011
- Reductions in cortisol associated with primary care brief mindfulness program for veterans with PTSD. Medical Care December 1, 2014
- Mindfulness-based stress reduction for patients with anxiety disorders: evaluation in a randomized controlled trial. Behaviour Research and Therapy January 27, 2011
and 1 more in the library