Mindful Yoga Therapy as an Adjunctive Treatment for PTSD Among OEF/OIF Veterans: A Pilot Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Locations
- 2
- Primary Endpoint
- Clinician Administered PTSD Scale (CAPS)
Study Overview
Brief Summary
The primary objective of the current study is to establish the safety and acceptability of Mindful Yoga Therapy as an adjunctive treatment for posttraumatic stress disorder (PTSD) among Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) Veterans. The current study also seeks to establish preliminary efficacy of Mindful Yoga Therapy for reduction of symptoms of PTSD and explore heart rate variability as a mechanism of therapeutic action.
Detailed Description
PTSD is a chronic, debilitating anxiety disorder associated with disability, functional impairment, and a host of co-morbid physical and mental health conditions. Although several treatments are successful in treating Veterans with PTSD, many Veterans fail to complete these treatments and many others complete treatment without significant relief from symptoms. Yoga is one integrative treatment option that has shown promise for a number of physical and mental health conditions, including the treatment of depressive and anxiety disorders in civilian samples, and chronic pain in Veterans. Yoga is widely offered in Veterans Affairs (VA) PTSD Treatment Programs, yet there is a lack of research on its efficacy for PTSD in Veterans.
Mindful Yoga Therapy (MYT)is a 12-week treatment protocol incorporating meditation, breathing exercises, mindful movement practice, and guided rest (yoga nidra) that has been developed specifically for Veterans with PTSD. This pilot randomized clinical trial with cross-over waitlist comparison (RCT) will compare Immediate Mindful Yoga Therapy (MYT) plus Treatment as Usual (TAU) with Delayed MYT + TAU. Baseline (week 0), 12-week, and 24-week assessments, in addition to 36-week assessments for the delayed MYT treatment group, will include diagnostic, neurocognitive, and psychophysiological measures conducted by a research team member blinded to treatment condition.
Primary Aim: The primary aim of the current pilot study is to establish the safety and acceptability of Mindful Yoga Therapy as an adjunctive treatment for PTSD among OEF/OIF Veterans.
Specific Aim #1: To establish that MYT is a treatment that can be implemented safely. Hypothesis #1: There will be no significant difference in the number of adverse events between treatment groups from week 0 to week 12.
Specific Aim #2: To establish that MYT is a treatment that veterans find helpful and accessible. Hypothesis #2. At least 50% of participants completing the MYT treatment will report that the treatment was helpful and accessible as reported on self-report measures of treatment satisfaction, administered at the completion of the MYT treatment component of the study (week 12 for the immediate MYT treatment group; week 24 for the delayed MYT treatment group).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •OEF/OIF/OND Veteran
- •Ages 18-45
- •Currently enrolled in active PTSD treatment
- •Meet criteria for PTSD
- •Veteran with combat exposure during deployment
Exclusion Criteria
- •Current psychotic disorder or bipolar disorder
- •Current use of beta-blocker medication
- •Current regular yoga or meditation practice in the past month
- •Significant limitations or injuries
Outcomes
Primary Outcomes
Clinician Administered PTSD Scale (CAPS)
Time Frame: 12 weeks
The "gold standard" measure of frequency and intensity of PTSD symptoms.
Secondary Outcomes
No secondary outcomes reported