NCT06162741 Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans
| NCT ID | NCT06162741 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Post Traumatic Stress Disorder (PTSD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-08-19 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2024-08-19 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Kyle Possemato, PhD
PRINCIPAL INVESTIGATOR
Syracuse VA Medical Center, Syracuse, NY
Frequently Asked Questions
Who can join the NCT06162741 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post Traumatic Stress Disorder (PTSD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06162741 currently recruiting?
Yes, NCT06162741 is actively recruiting participants. Contact the research team at kyle.possemato@va.gov for enrollment information.
Where is the NCT06162741 trial being conducted?
This trial is being conducted at Phoenix, United States, San Diego, United States, St Louis, United States, Syracuse, United States.
Who is sponsoring the NCT06162741 clinical trial?
NCT06162741 is sponsored by VA Office of Research and Development. The principal investigator is Kyle Possemato, PhD at Syracuse VA Medical Center, Syracuse, NY. The trial plans to enroll 300 participants.
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