Trauma-Sensitive Yoga for Female Veterans With PTSD Who Experienced Military Sexual Trauma

Objectives: The overall goal of this project is to maximize the health, social functioning,
and quality of life of women Veterans with posttraumatic stress disorder (PTSD) who have
experienced military sexual trauma (MST). The specific aims of this randomized controlled
trial (RCT) are to evaluate the effectiveness of a trauma-sensitive yoga intervention
designed specifically for women who experienced sexual trauma as compared to a gold-standard
PTSD treatment, Cognitive Processing Therapy-Cognitive, to 1) treat PTSD and its co-morbid
symptoms of chronic pain and insomnia, 2) improve social functioning and quality of life, and
3) reduce the biological and psychophysiologic responses associated with PTSD in women
Veterans who experienced MST.

Research Plan: This four year RCT is the next step following the NRI Pilot Study (NRI 12-417)
in which the investigators demonstrated the feasibility of recruitment, retention,
randomization, intervention implementation, and data collection, including biological and
psychophysiological data. Women Veterans seeking treatment for PTSD who report chronic pain
and insomnia are being recruited from the Atlanta VAMC Trauma Recovery Program Women's Trauma
Program. Participants (n=210) will be randomly assigned to trauma-sensitive yoga (10 weekly
sessions) or Cognitive Processing Therapy-Cognitive (12 weekly sessions); both intervention
protocols are data-driven. The target enrollment sample size is 210, with a target final
sample of 100 or more. The investigators are conservatively allowing for 50%-60% retention,
based on pilot study results.

Methods: Data Collection: Data are collected at four points, baseline through 3-months
post-intervention. Outcome measures include self-report, clinical assessments and biologic
and psychophysiologic markers. Specific outcomes include PTSD symptom severity, chronic pain,
insomnia, social functioning, quality of life, cytokines (IL-6, IL-10), C-reactive protein,
dark-enhanced startle, and heart rate variability. Data Analysis: Comparisons between the
groups at baseline will be run using t-tests, Mann Whitney non-parametric tests, and
chi-square tests as appropriate. Multilevel mixed models (MLM) will be used to analyze the
differences between the groups over time. MLM adjusts for attrition (missing data) over time
and applies appropriate correlation structure between the time points.

Clinical Relevance: Women Veterans experience MST and PTSD at alarming rates; consistently
reported prevalence rates for both among VHA patient samples are 20% or more. MST and PTSD
put this population at risk for significant physical and mental health symptoms, including
chronic pain, suicide, and negative health behaviors. This RCT may provide sufficient
evidence to support an innovative, complementary and alternative PTSD treatment for women
Veterans who experienced MST. The positive effects of reducing distressing symptoms and
PTSD-related psychophysiological stress would likely improve social functioning and quality
of life and minimize the significant medical consequences of PTSD in this population. This
new, evidence-based PTSD treatment could supplement existing evidence-based PTSD treatment
modalities. Clinical guidelines for this innovative intervention based on evidence from this
clinical trial could be disseminated to and implemented in VA Medical Centers nationwide.

Inclusion Criteria:

- Women Veterans who experienced MST

- Diagnosed with PTSD related to MST

- Insomnia

- Willing to participate in either TC-TSY or CPT-C study intervention

Exclusion Criteria:

- Schizophrenia with significant psychotic symptoms

- Current, active suicidal intent or plan

- Current substance abuse or dependence

- Certain medical conditions that can contribute significantly to psychiatric symptoms,
including:

- poorly controlled hypo/hyperthyroidism

- kidney or liver failure

- Dementia

- Moderate or severe traumatic brain injury (TBI) or other cognitive impairment
sufficient to interfere with ability to give informed consent

- Pain due to acute injury (<3 months), post-surgical pain (<3 months) or pain due to
malignancy; pain related to injury and surgery are excluded to reduce risk of
exacerbating underlying injury

- Receiving mental health treatment outside of the VA

- Ongoing participation in mental health treatment at odds with study intervention (For
Example: yoga, trauma-focused treatment)