Mindful Yoga Therapy for Veterans With PTSD and Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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PTSD, Chronic Pain

Intervention / Treatment
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* Behavioral: Mindful Yoga Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OIF/OEF/OND Veteran Ages 18-45 A willingness to participate in yoga and ability to commit to two 75-minute sessions per week for 12 weeks. Currently enrolled (under active care) at the PTSD firm or the MST group at VACHS, West Haven Participants will meet clinical criteria of PTSD (DSM-IV-TR) Comorbid conditions, including substance abuse/dependence will be allowed except as noted under exclusion criteria. Veteran with combat exposure or military sexual trauma during deployment(s). Non-cancer pain score (NRS pain score > 4 on a 0-10 scale whereby 0=no pain and 10=worst pain imaginable) and presence of pain for >3 consecutive months Exclusion Criteria: Any diagnosis of current comorbid psychotic disorders or bipolar disorder Active SI/HI Primary and only pain complaint as headache disorder A regular yoga or meditation practice in past month (more than twice weekly) Participants with significant limitations or injuries (Potential participants with significant limitations or injuries will be evaluated on an individual basis by research team and the yoga therapists.) Inability to speak or read English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful Yoga Therapy<br>12 sessions of Mindful Yoga Therapy delivered two times per week for 75 minutes each. | Behavioral: Mindful Yoga Therapy<br>* Veterans will participate in twice weekly Mindful Yoga Therapy, which includes meditation, breathing practices, physical postures/movements, and guided rest (yoga nidra), as well as daily home practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic Stress Disorder Checklist - Military Version (PCL-M) | A 17-item self- report measure of PTSD symptoms. | 24 weeks | 
| Numeric Rating Scale of Pain Intensity (NRS-I) | 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. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| West Haven Yale Multidimensional Pain Inventory - Interference Scale (WHYMPI-I) | The 9 item self-report Interference subscale of the WHYMPI will be used to assess pain-related disability. | 24 weeks | 
| Mindful Yoga Therapy Evaluation of Treatment Questionnaire | Consists of 20 items that require individuals to rate different aspects of the treatment. | 24 weeks | 
| Pain Treatment Credibility Questionnaire | A 3-item self-report measure developed to assess the credibility of Mindful Yoga as a viable intervention for pain. | 24 weeks | 
| Pain Treatment Satisfaction Questionnaire | A 6-item self-report measure developed to assess satisfaction with MYT group logistics (time, frequency, duration, and format). | 24 weeks | 
| Beck Depression Inventory (BDI) | 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. | 24 Weeks | 
| State-Trait Anxiety Inventory (STAI) | 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 | 24 weeks | 
| Difficulties in Emotion Regulation Scale (DERS) | 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) | 24 weeks | 
| Military Sexual Trauma | 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? | 24 weeks | 
| State-Trait Anger Scale (STAS) | 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). | 24 weeks | 
| Quality of Life (QOL) | 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. | 24 Weeks | 
| Pain Catastrophizing Scale (PCS) | 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. | 24 weeks | 
| Kentucky Inventory of Mindfulness Skills (KIMS) | 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. | 24 weeks | 
| Anxiety Sensitivity Index (ASI) | 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. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Yoga, Complementary and Alternative Medicine (CAM), Chronic Pain