Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for V… (NCT06162741) | Clinical Trial Compass
RecruitingNot Applicable
Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans
United States300 participantsStarted 2024-08-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 trainin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Depression Anxiety and Stress Scale (DASS-21) Change
Timeframe: Up to 24 weeks: Baseline, 8 weeks, 16 weeks, 24 weeks