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

Not Applicable

Recruiting

• Conditions: Post Traumatic Stress Disorder (PTSD); Depression; Anxiety

• Registration Number: NCT06162741
• Lead Sponsor: VA Office of Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-29
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Inclusion Criteria:<br><br>To be eligible, participants must be:<br><br> - enrolled in VA primary care through the local VA site<br><br> - report clinically significant psychological distress as measured in at least one of<br> three areas:<br><br> - PTSD operationalized by 30 on the PCL-5 plus endorsing a criteria A stressor<br><br> - depression operationalized as 10 on the PHQ-9<br><br> - anxiety operationalized by 10 on the GAD-7<br><br>Exclusion Criteria:<br><br>Exclusion criteria are minimized to allow inclusion of any primary care patients with<br>psychological distress that would normally receive treatment in primary care. Patients<br>will be excluded if they demonstrate symptoms that would not allow them to actively<br>participate in the interventions:<br><br> - gross cognitive impairment<br><br> - suicide attempt or desire to commit suicide in the last month<br><br>To allow the study to isolate the effects of the intervention and ensure patient<br>treatment preferences are honored, patients will be excluded if they:<br><br> - had a psychotherapy appointment outside of primary care within the last month and<br> have future appointment scheduled<br><br> - had a change in psychiatric medication outside of VHA primary care in the last 2<br> months<br><br> - voice a preference to be directly referred to specialty mental health care<br><br>Veterans with mild TBI, and alcohol/ substance use disorders will not be excluded because<br>these problems commonly co-occur with psychological distress, and individuals with these<br>conditions have previously benefited from mindfulness and problem-solving training.<br>Patients who receive Primary Care Mental Health Integration (PCMHI) services will not be<br>excluded as this is part of the usual primary care services that all Veterans receive.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depression Anxiety and Stress Scale (DASS-21) Change

Secondary Outcome Measures

Name	Time	Method
Satisfaction with Life Scale (SWLS);PTSD Checklist for DSM-5 (PCL-5)