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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares a mindfulness meditation class with a class that teaches problem-solving skills and ways to cope with challenges. It is for Veterans in VA primary care who have symptoms of anxiety, depression, or PTSD (stress after trauma). The study tests whether these classes ease symptoms and help Veterans function better in daily life.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be enrolled in VA primary care at the local study site.
  • You must have significant distress in at least one area: PTSD, depression, or anxiety, based on a symptom survey.
  • The listed survey scores are 30 on the PCL-5 for PTSD, 10 on the PHQ-9 for depression, or 10 on the GAD-7 for anxiety. For PTSD, you must also report a qualifying traumatic event.

Who can't join

  • Severe trouble with memory or thinking that would keep you from taking part.
  • A suicide attempt or a desire to end your life in the past month.
  • A talk therapy visit outside primary care in the past month, with another visit scheduled.
  • A change in mental health medicine outside VHA primary care in the past 2 months.
  • A preference to be sent directly to specialty mental health care.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (4)

AZ

CA

MO

NY