Primary Care-Based Mindfulness Intervention for Veterans With PTSD

Not Applicable

Completed

• Conditions: PTSD
• Interventions: Behavioral: Primary Care-Brief Mindfulness Program; Behavioral: Primary Care-Treatment as Usual

• Registration Number: NCT02399696
• Lead Sponsor: Syracuse VA Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-03
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-26
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary Care-Brief Mindfulness Program	Primary Care-Brief Mindfulness Program	A 4-week group program adapted from the 8-week Mindfulness Based Stress Reduction (MBSR) curriculum.
Primary Care-Treatment as Usual	Primary Care-Treatment as Usual	Typical VA primary care treatment, including mental health services delivered by primary care staff.

Primary Outcome Measures

Name	Time	Method
PTSD symptoms as measured by the PTSD Checklist	8 weeks

Secondary Outcome Measures

Name	Time	Method
Depression symptoms as measured by the Patient Health Questionaire-9	8 weeks