The NCCAM Exploratory/Developmental Grant for Clinical Studies (R21) PA NUMBER: PAR-06-090 encourages """"""""research characterized by novel ideas that may differ substantially from current thinking in a field,"""""""" providing solid data to support justification for a future clinical study."""""""" It encourages studies to develop and validate testing of biological and behavioral outcome measures in humans for use in CAM clinical research. The central question in this research proposal is: can a popular technique that specifically targets active mastery and improved affect regulation, yoga, which is utilized by approximately 4% of the US population each year (1), improve the constellation of PTSD symptoms, multiple somatic complaints, social and occupational impairment and high health care utilization that has been documented in hundreds of thousands of women in the US? Research has demonstrated a close association between trauma exposure and 1) PTSD, anxiety &depression, 2) loss of affect regulation, 3) poor quality of life, and 4) high health care utilization (2, 3). This study will explore how a popular body-mind technique, yoga, compares with a attentional control group condition, Women's Health Education (WHE), in the treatment of heretofore treatment- unresponsive adults with PTSD, and measure whether yoga can affect """"""""the attitudes and beliefs"""""""" that """"""""can reduce psychological stress and contribute to positive health outcomes."""""""" The study of yoga for chronic PTSD is in line with the empirical research that supports the notion that autonomic dysregulation plays a significant role in the persistence of PTSD (4), and with the hypothesis that an increased capacity for self-regulation is associated with a decrease in the severity of this symptom constellation. We recently completed a small pilot study of yoga for PTSD with promising results that deserve further exploration. In the proposed study, 128 women between the ages of 18 and 58 with treatment resistant PTSD and at least three years of previous conventional treatment will be screened, of whom 64 will be randomly assigned to receive 10 weeks of yoga classes or an attentional control group, WHE. Both Yoga treatment and WHE will entail one weekly one-hour protocolized group meeting. Treatment expectations will be measured. Blind raters will conduct detailed measures of psychiatric status and treatment efficacy at baseline, wk 5 (half way through treatment), wk 10 (termination of treatment), and 3 months after termination of treatment. Both psychological and biological assessment measures will be used: 1) standard psychological tests for PTSD, 2) other psychiatric conditions, 3) measures of affect and mood regulation, 4) body awareness, 5) quality of life, 6) health care utilization, 7) resting heart rate (HR) and heart rate variability (HRV). 1 Saper, R.B., Eisenberg, D.M., Davis, R.B., Culpepper, L., Phillips, R.S., 2004. Prevalence and patterns of adult yoga use in the United States: results of a national survey. Altern. Ther. Health Med. 10 (2), 44-49. 2 Van der Kolk Empirical Basis of Complex PTSD van der Kolk BA, Roth S, Pelcovitz D, Sunday S, Spinazzola J: Disorders of Extreme Stress: The Empirical Foundation of a Complex Adaptation to Trauma J Traum Stress, 18 ( 5), 389-399, 2005. 3 Felitti, V.J., Anda, R.F., Nordenberg, D, Williamson, D.F., Spitz, A.M., Edwards, V., et al. (1997). Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults: The Adverse Childhood Experiences (ACE) Study. Am J Preventive Med, 14, 245-258. 4 van der Kolk BA. 2006. Clinical Implications of Neuroscience Research in PTSD. Ann N.Y. Acad. Sci. 1071: 277-293.
Because about 7.8% of the US population suffers from PTSD, which has high co-morbidity with multiple medical, social and occupational problems, and because more than 10% of the US population has a childhood history of trauma, and because people with such histories have a 4-12 times greater risk to develop alcoholism, depression, drug abuse, and to make suicide attempts, a 2-4 times greater risk for smoking, a 1.4- 1.6 times greater risk for physical inactivity and obesity, and a 1.6-2.9 times greater risk for heart disease, cancer, chronic lung disease, stroke and diabetes (1), finding effective interventions has profound public health implications. 1, Felitti, V.J., Anda, R.F., Nordenberg, D, Williamson, D.F., Spitz, A.M., Edwards, V., et al. (1997). Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults: The Adverse Childhood Experiences (ACE) Study. Am J Preventive Med, 14, 245-258.
|West, Jennifer; Liang, Belle; Spinazzola, Joseph (2017) Trauma Sensitive Yoga as a complementary treatment for posttraumatic stress disorder: A Qualitative Descriptive analysis. Int J Stress Manag 24:173-195|
|van der Kolk, Bessel A; Stone, Laura; West, Jennifer et al. (2014) Yoga as an adjunctive treatment for posttraumatic stress disorder: a randomized controlled trial. J Clin Psychiatry 75:e559-65|