Complementary and Alternative Medicine treatment for Post-Traumatic Stress Disorder (PTSD) was the subject of the meeting held May 17, 2011 in Washington DC. Participants who attended included representatives of the Department of Defense, Department of Veterans Affairs, and the Department of Health and Human Services (National Institutes of Health, National Center for Complimentary and Alternative Medicine).
An evidence review identified that the highest quality evidence exists for acupuncture. However, strong conclusions cannot reliably be drawn on the basis of a single Randomized Control Trial (RCT). The greatest breadth of evidence exists for relaxation interventions-three RCTs were identified that examined forms of breathing and muscle relaxation. In each case, the trials were preliminary and design flaws limited interpretation of study findings, which were positive overall. Further conclusions cannot be made in the absence of well-designed investigations of these modalities.
The evidence base for meditation therapies is similarly limited by a paucity of well-designed trials, although early evidence is promising. In addition to a lack of scientific rigor and the need to replicate preliminary findings, the current literature is limited to concentrative meditative techniques. No RCTs of other common mind-body interventions, including mindfulness meditation and yoga, were identified in our review of the published, peer-reviewed literature. For manipulative and body-based CAM therapies, the evidence base is extremely limited, and for movement-based and energy therapies, we identified no RCTs, published or in progress. Based on the discussion at the meeting an addendum to the report will examine CAM treatments in depression and anxiety disorder.
In a survey presented at the meeting concerning CAM practice in the Department of Veterans Affairs, in 2011, 89% of VA facilities offer CAM therapies compared to 84% in 2002. Of facilities offering CAM, more directly provide CAM therapies compared to a 2002 (65% versus 45%). The five most common CAM provided are Meditation (72% of VA hospitals); Stress Management / Relaxation Therapy (66%); Guided Imagery (58%) Progressive Muscle Relaxation (53%); and Biofeedback (50%).
Participants identified that efforts should be undertaken to improve documentation of CAM in the VA electronic health record. A Veterans Affairs CAM working group is developing clinical directives related to the use of CAM therapies within the VA. The workgroup will also recommend standards for credentialing and privileging CAM providers within VA.
Study design issues for PTSD and CAM include: defining fidelity, clarification therapeutic dose, defining controls/placebos, and qualitative / quantitative data collection strategies. Participants recommended that the study of the underlying mechanism should be included in studies. Examples of mechanism measures include - control of attention, relaxation response, norepinephrine, epinephrine, cytokines, neuropeptides, cortisols, hyperarousal, heart rate variability, and advanced imaging such as Positron Emission Tomography, functional Magnetic Resonance Imaging and Magnetoencephalography. CAM approaches may need to be modified to ensure appropriateness for the PTSD patient population. Sleep is an important issue for PTSD and outcome measures should include this domain. Similarly, there may be promise in evaluating outcome measures which focus on pain, treatment adherence, anxiety, adjustment issues, adverse effects, family and social functioning, depression and other co-morbidities.
The VA Office of Research and Development (ORD) is in the process of reviewing applications for the recent Request for Application (RFA) focused on meditative based treatments for PTSD. Depending on scientific review and available funding it is anticipated that up to 3 projects will be supported and will begin in the fall of 2011. ORD will discuss the results of this meeting with VA research offices and post a meeting summary on the ORD internet page. The VA Office of Research and Development has a continuing interest in this topic and encourages investigators to apply for support through merit review mechanisms.
The VA Office of Mental Health is pursuing development of clinical demonstration projects which would examine current treatment and practice of meditation for PTSD at 4 to 8 sites. Meeting participants noted that it is important for the demonstration projects to examine how changes in provider type, setting, and context impact patient CAM outcomes, and potential adverse events associated with CAM treatments.
Meeting participants identified the following issues for consideration. 1) developing CAM manuals and moving treatment approaches towards standardized versions of CAM; 2) using common measures across sites; 3) exploring provider acceptability of CAM treatment in this population; and 4) developing plans if there are a lack of qualified instructors for CAM.
In 2007, a national survey identified that 38.3% of adults use Complementary and Alternative Medicine (CAM). CAM use is greater in women and those with higher education and income. The most CAM use reported was of natural products (17.7%) followed by deep breathing (12.7%) and meditation (9.4%). A recent publication examined CAM use in active duty military personnel who participated in the millennium cohort study. Over a 12 month period, 39% indicated that they used at least one CAM treatment. Individuals reporting one or more health conditions were more likely to use CAM.
CAM is coming into the mainstream of healthcare, with rapid growth in utilization over the last several years. CAM use in Post-Traumatic Stress Disorder (PTSD) was the subject of the meeting held May 17, 2011 in Washington DC. Participants who attended included representatives of the Department of Defense, Department of Veterans Affairs (VA), and the Department of Health and Human Services (National Institutes of Health, National Center for Complimentary and Alternative Medicine).
In his opening remarks, the VA Deputy Secretary emphasized that the VA has begun the following activities:
The Deputy Secretary emphasized that collaborating with one another will help us advance this research more quickly and more effectively. The Deputy Secretary emphasized that one particular treatment to evaluate is meditation. Meditative techniques should be culturally sensitive, easily learned, and translate across different veteran populations. The VA and DoD have dedicated funds for this research; additional funding sources are also sought.
The evidence review sought to address the following questions:
Additionally, an assessment of risk of bias: applied quality criteria described in Agency for Healthcare and Research Quality (AHRQ) Methods Guide for Effectiveness and Comparative Effectiveness Reviews was conducted.
Considered in sum, the highest quality evidence exists for acupuncture. However, strong conclusions cannot reliably be drawn on the basis of a single RCT; replication of findings is required. The greatest breadth of evidence exists for relaxation interventions-three RCTs were identified that examined forms of breathing and muscle relaxation. In each case, the trials were preliminary and design flaws limited interpretation of study findings, which were positive overall. Further conclusions cannot be made in the absence of well-designed investigations of these modalities.
The evidence base for meditation therapies is similarly limited by a paucity of well-designed trials, although early evidence is promising. In addition to a lack of scientific rigor and the need to replicate preliminary findings, the current literature is limited to concentrative meditative techniques. No RCTs of other common mind-body interventions, including mindfulness meditation and yoga, were identified in our review of the published, peer-reviewed literature. However, 17 ongoing and/or unpublished studies registered with ClinicalTrials.gov, suggesting that this is a burgeoning area of research. Approximately half of these trials are ongoing, and the majority are recruiting active military and/or Veteran samples. Thus, a significantly larger, broader, and stronger evidence base can be anticipated within the next several years.
For manipulative and body-based CAM therapies, the evidence base is extremely limited, and for movement-based and energy therapies, we identified no RCTs, published or in progress. Research on CAM therapies for PTSD appears to be on the rise, as suggested by the 17 pertinent RCTs identified in ClinicalTrials.gov.

The term CAM was used in the discussion to refer to a category of therapies - mind-body medicine (e.g., meditation, yoga, and acupuncture), manipulative, and body-based practices (e.g., spinal manipulation, massage therapy). Meeting participants at times did not identify the particular CAM therapy that was the focus of their comments. Another issue relates to the definition of CAM, some regard biofeedback, progressive muscle relaxation, or other treatments as CAM, while others consider these techniques to be standard treatment. Regarding classification of PTSD, current thinking is that PTSD is a disorder of physical and emotional dysregulation rather than as an anxiety disorder.
Comments raised by meeting participants:
It was suggested that the topic area of meditation include strategies that build off meditative techniques such as yoga, and other movement based forms of meditation. Lessons also might be learned from the incorporation of mindfulness in cognitive behavioral therapy. Another potential question for a different literature review might be to consider which CAM treatments may be the most likely candidates for greatest potential benefit based on how well the theoretical mechanisms of action match the key features of PTSD that would be targets for improvement (i.e. hyperarousal, numbing, avoidance and re-experiencing). For example, mindfulness meditation could be a candidate due to the findings that mindfulness meditation reduces hyperarousal and promotes openness to versus avoidance of experience, e.g. distressing images, memories, emotions.
The team that developed the evidence review will also perform a search for systematic reviews that evaluate eligible CAM treatments for related mental health disorders such as depression and anxiety disorder. The team will use a formal process to identify eligible reviews, and apply criteria to rate the quality of eligible reviews. In the report they will summarize and critically discuss each fair or good quality systematic review. Included reviews will be limited to those published within the past 5 years. A separate summary will be developed as a supplement to the current report.
In 2011, 89% of VA facilities offer CAM therapies compared to 84% in 2002. Of facilities offering CAM, more directly provide CAM therapies compared to a 2002 (65% versus 45%). The five most common CAM provided are Meditation (72% of VA hospitals); Stress Management / Relaxation Therapy (66%); Guided Imagery (58%) Progressive Muscle Relaxation (53%); and Biofeedback (50%);. If facilities offer CAM, they are providing more types of CAM therapy compared to 2002. The most common reasons for providing CAM therapy are for wellness promotion and patient preference. The most common reasons for not providing CAM are lack of providers, perceived lack of patient interest, and perceived lack of evidence for efficacy.
Of the facilities that offer meditation, 79% offer mindfulness meditation, 13% offer mantra repetition meditation, and 8% offer Transcendental Meditation. The top five most common conditions associated with CAM treatment are stress management, anxiety, PTSD, depression, and back pain. The greatest use of CAM therapies is in the mental health field. A variety of VA providers offer CAM therapies - psychologists, physicians, recreational therapist, nurses, physical therapists, occupational therapists, social workers, and others. The survey indicated that documentation of CAM therapies in the medical record is poor. Additionally CPT and HCPCS codes are usually not used. The survey indicated that the belief by health care providers in the scientific evidence of the effectiveness of CAM therapies appears greater than the actual documented evidence of effectiveness.
There is a wide array of clinical practice approaches to CAM. CAM modalities can help connect patients with mental health services and provides an entry way to other evidenced-based treatment modalities as needed.
Efforts should be undertaken to improve documentation of CAM in the VA. A CAM working group led by Dr. Ezeji-Okoye is working on clinical directives related to the use of CAM therapies within the VA. The workgroup will also recommend standards for credentialing and privileging CAM providers within VA.
CAM therapies are likely to have modest treatment effect sizes. Additionally, providing CAM as an adjunctive treatment can make sample sizes needed to conduct the study a challenge. Selection of appropriate outcome measures is also important. It should not be lost that CAM treatments are desired by patients, so quality of life, perceived health status, and satisfaction should be considered.
Meditation at its basic level is learning to train attention. This is also a central ingredient in many other CAM techniques (tai chi, yoga, etc.). How does learning to focus attention or training attention affect/help existing strategies for managing PTSD?
Design issues include: defining fidelity, clarification therapeutic dose, defining controls/placebos, and qualitative / quantitative data collection strategies. Touch based / movement therapies should also be investigated, but may not be appropriate for every veteran patient suffering from PTSD. The study of the underlying mechanism should be included in studies, but may conflict with perceptions regarding the holistic philosophy of CAM. Examples of mechanism measures include - control of attention, relaxation response, norepinephrine, epinephrine, cytokines, neuropeptides, cortisols, hyperarousal, heart rate variability, and advanced imaging such as Positron Emission Tomography, functional Magnetic Resonance Imaging and Magnetoencephalography.
CAM approaches may need to be modified to ensure appropriateness for the PTSD patient population. Difficulties in learning meditation due to hyper arousal may require adapting meditative techniques for this population and individualizing techniques when necessary. Potential for disassociation may necessitate reducing overall length of meditations and periods of silent practice. Modifying the environment, time of therapy, intensity, etc. should be considered and these issues could be considered as questions for empirical study. It was suggested that CAM may have an impact on traditional treatment effectiveness, loss to follow up, number of required sessions, and patient adherence to standard therapy.
Sleep is another important issue for PTSD and outcome measures should include this domain. Similarly, there may be promise in evaluating outcome measures which focus on pain, treatment adherence, anxiety, adjustment issues, adverse effects, family and social functioning, depression and other co-morbidities. The potential of CAM as an adjunctive therapy to more proven therapies needs to be addressed. In addition, CAM may offer some Veterans a more acceptable avenue for entering care than more evidence-based therapies. Studies should examine whether offering CAM increases uptake of and retention in more proven therapies such as prolonged exposure therapy.
Self- administered and health care provider-administered approaches should be included. We need better descriptive / observational data. As noted, a challenge is that CAM is not coded consistently in the medical record. PTSD chronicity also merits consideration. Veterans may receive VA services for PTSD well after the initial traumatic exposure (>1 Yr). Fidelity of treatment is an important challenge in a clinical study. We also need to have better measures of CAM treatment fidelity.
Also, it was recommended that it would be premature to initiate large randomized trials of CAM treatments before we have worked out key methodological issues such as fidelity of treatment, outcome measures, and understanding contextual effects. Intent to treat analysis may not be the best approach for CAM therapies. Measuring adherence is important.
CAM therapy can have patient benefits even without treatment efficacy. We should attempt to understand these as well. In CAM study designs, many sham control procedures are difficult and may not be an appropriate control strategy.
Existing studies of non-CAM therapies such as prolonged exposure has often used relaxation therapy as a control, giving us evidence that relaxation therapy in isolation is not as effective as prolonged exposure.
The VA Office of Research and Development (ORD) is in the process of reviewing 21 applications for the recent Request for Application (RFA) focused on meditative based treatments for PTSD. Depending on scientific review and available funding it is anticipated that up to 3 projects will be supported and will begin in the fall of 2011. The VA Office of Research and Development has a continuing interest in this topic and encourages investigators to apply for support through merit review mechanisms.
VA also will fund demonstration projects to determine the feasibility of incorporating meditation into VA mental health care for PTSD and to examine outcomes for at least two forms of meditation. Demonstration projects also will provide some information on the impact of various contextual factors, such as sequencing of meditation with other evidence-based treatments, provider type, setting, and context, on patient CAM outcomes. Potential adverse events associated with CAM treatments can also be monitored.
A meeting participant noted, based on his experience treating active duty PTSD patients, that many of them have pain in some form, such as persistent headaches. Patients with chronic pain are distracted from living a normal life style, and for patients with PTSD it is a reminder of their injury. In this state, incorporating meditation may be difficult. Based on his experience, acupuncture appeared to provide benefit for these patients.
Questions suggested for consideration in the demonstration projects:
The VA Office of Mental Health is pursuing development of clinical demonstration projects which would examine current treatment and practice of meditation for PTSD at 4 to 8 sites. Meeting participants identified the following important issues for consideration.
David Atkins, MD, Director of the Quality Enhancement Research Initiative (QUERI) program, ORD, VHA
Ranjana Banerjea, PhD, Portfolio Manager, Health Services Research and Development, ORD, VHA
Jean-Louis Belard, MD, PhD, Mac, Colonel (Ret), Scientific Director, Henry Jackson Foundation for the Advancement of Military Medicine
Jill Bormann, PhD, RN, Clinical Nurse Specialist in Adult Psychiatric-Mental Health Nursing at the VA San Diego Healthcare System
Josephine P. Briggs, MD, Director, National Center for Complementary and Alternative Medicine, NIH.
Remy Coeytaux, MD, PhD, Associate Professor of Community and Family Medicine at Duke University School of Medicine
Louanne Davis, PsyD, Psychologist at the Roudebush VA Medical Center
Ralph G. DePalma, MD, FACS, Special Operations Officer, VA Office of Research and Development
Emmeline Edwards, PhD, Director of the Division of Extramural Research, NCCAM, NIH
Stephen Ezeji-Okoye, MD, Deputy Chief of Staff, VA Palo Alto Health Care System.
Thomas Findley, MD, PhD, clinician, VA Medical Center East Orange NJ
Tracy W. Gaudet, MD, Director of the VHA Office of Patient-Centered Care and Cultural Transformation
Thomas Geracioti, MD Research Physician at the Cincinnati VAMC
Theresa C. Gleason, PhD, Portfolio Manager, Mental Health Research Portfolio, ORD, VHA
John R. Glowa, PhD, Program Officer NCCAM, NIH
W. Scott Gould, Deputy Secretary, Department of Veterans Affairs
Anita Hickey, MD, Director of Integrative Pain Medicine and Pain Research, Naval Medical Center San Diego
Kristen Huntley, PhD, Program Officer, Division of Extramural Research, NCCAM
Sat Bir Singh Khalsa, PhD, Research Director of the Kripalu Center for Yoga and Health and an Assistant Professor of Medicine at Harvard Medical School at Brigham and Women's Hospital
Amy Kilbourne, PhD Director of the VA Ann Arbor National Serious Mental Illness Treatment Resource and Evaluation Center
John (Jack) Killen, Jr., MD, Deputy Director of NCCAM, NIH
Joel Kupersmith, MD Chief Research and Development Officer, VHA
Kathryn Marley Magruder, MPH, PhD, Research Health Scientist, VA Medical Center in Charleston SC
Richard C. Niemtzow, M.D., Ph.D., MPH, Colonel (Ret), USAF, MC, FS Represents the Department of Defense at the National
Institutes of Health National Center for Complementary and Alternative Medicine Advisory Council.
Bob O'Brien, PhD, Portfolio Manager, Health Services Research and Development, ORD, VHA
Alexander Ommaya, DSc, MA, Director of Translational Research, ORD, VHA
Timothy O'Leary, MD, PhD, Deputy Chief Research and Development Officer, ORD, VHA
Michelle Kennedy Prisco, MSN, ANP-C, Environmental exposure specialist, Department of Veterans Affairs' War Related Illness and Injury Study Center (WRIISC) , Washington, D.C.
Paula Schnurr, PhD, Deputy Executive Director of the VA National Center for Posttraumatic Stress Disorder
Jennifer Strauss, PhD, Clinical Psychologist, Health Services Investigator, Center for Health Services Research in Primary Care, Durham, NC and VISN Mental Illness Research, Education, and Clinical Center
Frances Stewart, MD, CAPT, MC, USN National Intrepid Center of Excellence (NICoE)
Helané Wahbeh, ND, Assistant Professor of Neurology at Oregon Health Sciences University
Antonette Zeiss, PhD, Acting Deputy Chief Patient Care Services Officer for VHA Office of Mental Health