RecruitingNot ApplicableNCT06162741

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

Sponsor

VA Office of Research and Development

Enrollment

300 participants

Start Date

Aug 19, 2024

Study Type

INTERVENTIONAL

Conditions

Depression Anxiety Post Traumatic Stress Disorder (PTSD)

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria7

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.

Interventions

BEHAVIORALPrimary Care Brief Mindfulness Training (PCBMT)

PCBMT is a manualized intervention that is a brief adaptation of MBSR Mindfulness Based Stress Reduction (MBSR). It was developed by Dr. Scott Treatman and Dr. Dessa Bergen-Cico (Co-I). PCBMT consists of four 90-minute classes (360 total minutes of classes). Instruction encompasses sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go. In-class meditations are followed by a group process of the experience. At-home practice between sessions is encouraged and is guided by simple checklists asking students to check the meditation they practiced and write a few comments about what the experience was like.

BEHAVIORALMoving Forward (MF)

Moving Forward (MF) is a transdiagnostic class that seeks to build resilience and reduce emotional distress by teaching step-by-step problem-solving skills such as "stop, slow down, think and act". The format that will be used as the comparison is manualized, group-delivered, primary care-based, often co-delivered by MH providers and peers, and considered a usual care practice in many VHA PCMHI programs. MF content is derived from problem solving therapy, which has clear effectiveness in reducing depression and other types of psychological distress. While the MF manual consists of four 60-minutes classes, for this study the 4 classes will be 90-minutes long to equate the length of both conditions. No new content will be added rather the additional time will be used to allow Veterans to complete worksheets in class and allow more group discussion.