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) and
      chronic pain among OEF/OIF/OND Veterans. The current study also seeks to establish
      preliminary efficacy of MYT for reduction of PTSD and chronic pain symptoms and explore
      anxiety sensitivity as a mechanism of therapeutic action.

Mindful Yoga Therapy for Veterans With PTSD and Pain

PTSD

Chronic Pain

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 clinical trial will examine the
      efficacy of MYT with baseline, 12 week, and 24 week follow-up assessments that will include
      diagnostic, neurocognitive, and psychophysiological measures conducted by a research team
      member blinded to the study purpose.

Mindful Yoga Therapy

Mindful Yoga Therapy as an Adjunctive Treatment for Veterans With PTSD and Pain

A 17-item self- report measure of PTSD symptoms.

Global pain intensity will be assessed using the NRS-I, an 11-point numeric rating scale where a score of "0" represents no pain and a score of "10" represents the worst pain imaginable. Participants will be asked to rate their average current pain (e.g. today's pain) along with their average pain over the past week.

The 9 item self-report Interference subscale of the WHYMPI will be used to assess pain-related disability.

Consists of 20 items that require individuals to rate different aspects of the treatment.

A 3-item self-report measure developed to assess the credibility of Mindful Yoga as a viable intervention for pain.

A 6-item self-report measure developed to assess satisfaction with MYT group logistics (time, frequency, duration, and format).

A 21-item self- report scale of depression. Each item is rated on a 4-point scale with 0 as the low value 3 as the high value. A higher score indicates greater depression.

Trait anxiety measures relatively stable individual differences in anxiety proneness and refers to a general tendency to respond to perceived threats in the environment with anxiety reactions, whilst the state portion refers to current feelings of anxiety. Participants respond on a 4-point frequency scale ranging from "almost always" to "almost never" to items that reflect the either the presence or absence of anxiety

The DERS is a brief, 36-item, self- report questionnaire designed to assess multiple aspects of emotion dysregulation. The measure yields a total score as well as scores on six scales derived through factor analysis: 1) Nonacceptance of emotional responses (NONACCEPTANCE), 2) Difficulties engaging in goal directed behavior (GOALS), 3) Impulse control difficulties (IMPULSE), 4) Lack of emotional awareness (AWARENESS), 5) Limited access to emotion regulation strategies (STRATEGIES), 6) Lack of emotional clarity (CLARITY)

The presence of military sexual trauma will be assessed via the following "yes/no" questions: "While you were in the military, did you receive uninvited and unwanted sexual attention, such as touching, cornering, pressure for sexual favors, or sexual remarks?" and "Did someone ever use force or threat of force to have sexual contact with you against your will?"

The STAS consists of 20 statements that require individuals to rate how they generally feel on a four point scale and is designed to distinguish experiences of trait anger (a general tendency to react angrily to perceived situations) and state anger (a temporary emotional state).

The Veterans SF-36 will be used to assess health-related quality of life. This measure has demonstrated good internal consistency (.78-.93 across 8 subscales) and is strongly correlated with socioeconomic status and morbidities.

The Pain Catastrophizing Scale is a 13-item self report scale that examines thoughts and feelings people may experience when they are in pain and are grouped into three different categories: Rumination, Magnification and Helplessness.

The Kentucky Inventory of Mindfulness Skills is a 39-item self report measure assessing four facets of mindfulness including observing, describing, acting with awareness, and nonjudgment.

The Anxiety Sensitivity Index is a 16-item self-report measure that assesses fear of anxiety-related body sensations. Respondents rate the extent to which they agree with each statement using a 5 point Likert Scale.

12 sessions of Mindful Yoga Therapy delivered two times per week for 75 minutes each.

Mindful Yoga Therapy for Veterans With PTSD and Pain

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?