Stress Disorders, Post-Traumatic Clinical Trial
Official title:
Outcomes of a Holistic Yoga Program Designed to Relieve PTSD (RELIEVE Trial)
Given the limited effectiveness of current treatments and the burden PTSD places on Veterans, civilians and clinicians, this research aims to compare the effects of a standardized, traditional, holistic yoga intervention (postures, breathing, deep muscle contraction and relaxation practices) with a wellness program (wellness topics and physical activity) on PTSD symptoms.
Posttraumatic Stress Disorder constitutes a substantial proportion of the burden of illness
among Veterans. However, current PTSD treatments are not effective for all, and a significant
number remain symptomatic despite pharmacotherapy and psychotherapy. As a result, there has
been increased interest within the military and VA in Complementary and Alternative Medicine
approaches, such as yoga, to improve symptoms without requiring direct verbal processing of
the trauma. Yoga provides an innovative approach to calming hyperarousal, reducing
numbness/avoidance, and improving self-regulation of emotions, while cultivating physical and
emotional well-being. Because of this unique approach to the biological, psychological, and
social dimensions of PTSD, we believe that yoga interventions are poised to meet the demand
for more effective PTSD treatment options for Veterans. Recent research indicates that yoga
interventions can be delivered successfully to individuals who have PTSD and have the
potential to reduce clinician rated and self-reported overall PTSD symptoms, depression and
anxiety. However, few studies exist that have evaluated yoga for PTSD and they have involved
small sample sizes and are either uncontrolled or waitlist/usual care controlled. Also, there
is much variation among studies in the style and components of yoga interventions. Thus, a
randomized controlled trial of a standardized, traditional, holistic yoga intervention is
urgently needed to inform VA policy makers and clinicians of the potential benefits of yoga
as an adjunct to currently available PTSD treatments.
OBJECTIVE: The overall goal of this project is to compare the effects of a 16-week Holistic
Yoga Program (HYP) with a 16-week Wellness Lifestyle Program (WLP) on PTSD and related
symptoms and outcomes. This project has three specific aims: 1) to compare the effects of the
interventions (HYP vs. WLP) on overall PTSD symptom severity; 2) compare the interventions'
effects on PTSD-specific symptoms (anger, sleep), PTSD-related symptoms (depression, anxiety,
pain) and related outcomes (well-being/quality of life); 3) to manualize the Holistic Yoga
Program and training process for experienced yoga teachers to deliver HYP to individuals who
have PTSD in order to facilitate future study and dissemination efforts.
METHODS: This study sample will include 212 outpatients with a clinician-confirmed diagnosis
of PTSD, recruited from the Roudebush VA Medical Center as well as metropolitan area mental
health clinicians and military/Veterans' organizations, who will be randomly assigned to
receive the Holistic Yoga Program (HYP) or the Wellness Lifestyle Program (WLP). The HYP will
involve a standardized 16-week intervention consisting of: 1) in-person group yoga class
taught by a yoga therapist (Yoga Alliance minimum 200 hour level) with trained
assistants.Classes will include (1) yoga postures, breathing practices, deep muscle
contraction practices, relaxation practices, and integration of scientific rational and yoga
philosophy within the instruction; (2) video and audio recordings for home practice; and 4) a
Participant Handbook to reinforce concepts taught during in-person sessions. The WLP is an
attention control comprised of low intensity walking and didactics about wellness topics that
will also encourage home practice and provide a Participant Handbook to reinforce concepts
taught during in-person sessions.
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