Primary Care-Based Mindfulness Intervention for Veterans With PTSD

Study Overview
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Brief Summary
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Primary care patients typically do not receive adequate PTSD treatment because of their reluctance to engage in empirically-supported treatments offered in specialty care settings. Effective treatments for PTSD are also typically not provided in primary care. Brief skill-based treatments offered in primary care may alleviate symptoms and prepare patients to engage in additional treatment. VA primary care patients with PTSD (N=62) were recruited for a randomized clinical trial comparing a Primary Care-Brief Mindfulness Program (PC-bMP) to primary care-treatment as usual (PC-TAU). PC-bMP is a 4-week group program adapted from the 8-week Mindfulness Based Stress Reduction (MBSR) curriculum. Veterans in the PC-bMP condition demonstrated significantly greater decreases in PTSD and depressive symptoms from pre-treatment to post-treatment compared to PC-TAU. These gains were maintained at 8 and 12 week follow-up. PC-bMP participants experienced clinically significant decreases in PTSD, averaging a 15-point drop on the Clinician-Administered PTSD Scale. Exploratory analyses revealed that the describing, non-judging, and acting with awareness facets of mindfulness may account for decreases in PTSD. Our data support preliminary efficacy of a brief mindfulness-based intervention for Veterans with PTSD in primary care. Further research is needed to investigate how PC-bMP may facilitate engagement into full length empirically-supported treatment for PTSD.

Official Title
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Primary Care-Based Mindfulness Intervention for Veterans With PTSD

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: Primary Care-Brief Mindfulness Program
* Behavioral: Primary Care-Treatment as Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) sub-threshold or diagnostic level PTSD related to military service as determined by the Clinician Administered PTSD Scale Exclusion Criteria: 1) gross cognitive impairment, 2) moderate to severe traumatic brain injury, 3) suicide attempt or intent to commit suicide in the last two months, and 4) receipt of mental healthcare (psychotherapy or medication) outside VA primary in the last two months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary Care-Brief Mindfulness Program<br>A 4-week group program adapted from the 8-week Mindfulness Based Stress Reduction (MBSR) curriculum. | Behavioral: Primary Care-Brief Mindfulness Program<br>* A 4-week group program adapted from the 8-week Mindfulness Based Stress Reduction (MBSR) curriculum<br>|
| Active Comparator: Primary Care-Treatment as Usual<br>Typical VA primary care treatment, including mental health services delivered by primary care staff. | Behavioral: Primary Care-Treatment as Usual<br>* Typical VA primary care treatment, including mental health services delivered by primary care staff.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD symptoms as measured by the PTSD Checklist |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression symptoms as measured by the Patient Health Questionaire-9 |  | 8 weeks |