MILITARY MEDICINE, 177, 9:1015, 2012 Healing Touch With Guided Imagery for PTSD in Returning Active Duty Military: A Randomized Controlled Trial Shamini Jain, PhD*†; CDR George F. McMahon, NC USN‡; LCDR Patricia Hasen, NC USN‡; CDR Madelyn P. Kozub, NC USN‡; Valencia Porter, MD, MPH∥; Rauni King, RN, MIH, CHTP§; Erminia M. Guarneri, MD§ ABSTRACT Post-traumatic stress disorder (PTSD) remains a significant problem in returning military and warrantsswift and effective treatment. We conducted a randomized controlled trial to determine whether a complementarymedicine intervention (Healing Touch with Guided Imagery [HT+GI]) reduced PTSD symptoms as compared totreatment as usual (TAU) returning combat-exposed active duty military with significant PTSD symptoms. Active dutymilitary (n = 123) were randomized to 6 sessions (within 3 weeks) of HT+GI vs. TAU. The primary outcome was PTSDsymptoms; secondary outcomes were depression, quality of life, and hostility. Repeated measures analysis of covariancewith intent-to-treat analyses revealed statistically and clinically significant reduction in PTSD symptoms ( p < 0.0005,Cohen's d = 0.85) as well as depression ( p < 0.0005, Cohen's d = 0.70) for HT+GI vs. TAU. HT+GI also showedsignificant improvements in mental quality of life ( p = 0.002, Cohen's d = 0.58) and cynicism ( p = 0.001, Cohen's d =0.49) vs. TAU. Participation in a complementary medicine intervention resulted in a clinically significant reductionin PTSD and related symptoms in a returning, combat-exposed active duty military population. Further investigation ofGT and biofield therapy approaches for mitigating PTSD in military populations is warranted.
seeking treatment, data suggests there are large numbers of Post-traumatic stress disorder (PTSD) is a common and persis- military personnel who may not meet clinical cutoffs for tent problem in military populations that warrants swift and PTSD immediately upon return from deployment, but whose effective treatment. Recent estimates suggest that among symptoms escalate to clinical levels even up to 12 months recent Iraq and Afghanistan veterans, 21.8% are diagnosed postdeployment.2,13 These findings suggest a need for swift, with PTSD, with prevalence rates increasing 4 to 7 times after effective, and nonstigmatizing treatment of PTSD symptoms the invasion of Iraq.1 Substance use disorders, depression, and in postdeployment active duty personnel, as well as speak to interpersonal conflicts also substantially increase in these the need to address PTSD symptoms for active duty military soldiers,1,2 and physical health-related consequences such as in general health care settings as opposed to providing PTSD increased risk for hypertension and diabetes have also been treatment solely in mental health care settings.
noted.3,4 Not surprisingly, the incidence of PTSD appears toincrease with combat exposure.5–7 Complementary Medicine: Approaches and Use in Despite all best efforts to treat PTSD in our military, it remains untreated in a substantial number of those on active Similar to civilian populations, complementary and alterna- duty and/or recently deployed. These soldiers are more likely tive medicine (CAM) approaches are often sought out by to report mental health issues compared to their reserve military personnel, for a variety of health conditions. Recent comrades,8 and yet are significantly less likely to engage in studies estimate CAM use in U.S. Military populations to mental health services.8,9 In general, the younger cohort of range between 39.3 and 50.7%.14–16 The largest epidemio- Operations Enduring Freedom/Iraqi Freedom veterans are logical study reported that 41% of military personnel had notably loathe to seek conventional PTSD treatment, in part, reported CAM use in the past year, with 27% reporting use because of perceived stigmatization and negative beliefs of practitioner-assisted CAM therapies (such as acupuncture, about conventional mental health care (i.e., psychotherapy biofeedback, and biofield/energy healing14). Interestingly, and medications9–12). Even for those who may be open to the study reported that use of CAM was nearly doubledcompared to no CAM use for those with a PTSD diagnosis, *Samueli Institute, 2101 East Coast Highway, Suite 330, Corona Del Mar, suggesting that military personnel with PTSD are relatively CA 92625-1900.
high users of CAM.
†University of California San Diego, 9500 Gilman Drive, La Jolla, ‡Marine Corps Base, 21 Area Branch Medical Clinic, Naval Hospital Study Purpose and Hypotheses Camp Pendleton, Box 555191, Camp Pendleton, CA 92055-5191.
Given the high prevalence of PTSD symptoms in active §Scripps Center for Integrative Medicine, 10820 North Torrey Pines Road, duty personnel, a noted lack of initiation and/or adherence La Jolla, CA 92037.
to mental health treatments for PTSD in this population, kThe Chopra Center for Well Being, 2013 Costa Del Mar Road, Carlsbad, and supporting literature suggesting a potential openness to MILITARY MEDICINE, Vol. 177, September 2012 Delivered by Publishing Technology to: ProQuest IP: on: Tue, 04 Sep 2012 21:03:21 Copyright (c) Association of Military Surgeons of the U.S. All rights reserved.
HT+GI for PTSD in Returning Military CAM approaches in those with PTSD symptoms, we participants were awaiting further deployment and would not conducted a pilot, two-armed randomized controlled trial be available for follow-up assessment. Participants were ran- (RCT) of a CAM intervention (Healing Touch with Guided domized using a computer-generated randomization table by a Imagery [HT+GI]), compared to treatment as usual (TAU), statistician not affiliated with the study. This table was pro- in 123 active duty military personnel at Camp Pendleton, vided to two study co-ordinators who, each assigned patients to California. We hypothesized that this intervention would be their respective groups upon entry. Both the principal investi- effective in reducing PTSD symptoms (primary outcome) as gator and data analyst were blind to group assignment (group well as depression, health-related quality of life, and hostility status was coded with study numbers until data analyses were completed, at which point the group assignment was revealed).
Those randomized to the HT+GI group received 6 treatments over a 3-week period in addition to any other standard care,and those in TAU continued to receive their standard care for Recruitment, Eligibility, Screening, and Enrollment PTSD, which included various forms of psychotherapy The study took place at the Marine Corps Base Camp in Camp (including cognitive behavioral therapy, biofeedback, and Pendleton, California and was approved by the Clinical Inves- relaxation training), as well as in many cases, medications.
tigation Department, Naval Medical Center San Diego andScripps Office for the Protection of Research Subjects.
Recruitment and enrollment took place from July 2008 to July 2010. Flyers announcing the study were posted at the Deploy- Participants randomized to the intervention group received a ment Health Clinics (DHC) and the hospital mental health combined intervention of HT+GI. The purpose of combining department on Camp Pendleton. Health care providers at these these interventions was to provide the participant both with locations were introduced to the study by research staff mem- practitioner-based treatment (HT) to establish a "safe space" bers. During the postdeployment health reassessment for mil- using a nonstigmatizing touch-based therapy aimed at itary personnel returning from a combat zone, the Base DHC eliciting the participant's own healing response, whereas also providers identified potential candidates for the study via engaging in a self-care therapy (listening to GI CD) that screening of PTSD symptoms. To be potentially eligible for helped the patient to work with trauma-related issues includ- the study, participants were identified by DHC providers to be ing trust and self-esteem. HT is a type of biofield therapy that currently experiencing at least one or more of the following involves gentle, noninvasive touch by trained practitioners, hallmark PTSD symptoms: re-experiencing of trauma (via, e.g., who utilize specific techniques with the intention of working flashbacks, nightmares, intrusive thoughts/images, exaggerated with the body's vital energy system to stimulate a healing physical and/or emotional responses to triggers of trauma), response. Two nurses certified in HT, with several years of exaggerated arousal (including insomnia and/or sleep distur- experience in using HT with patients, provided the HT inter- bance, irritability, exaggerated startle response), emotional vention. Practitioners met on a regular basis to discuss use numbing, and/or avoidance (i.e., of people, places, or situations of specific techniques and ensure intervention delivery consis- that might remind them of the trauma). Potentially eligible tency. Practitioners utilized three specific HT techniques: participants were then referred to the research staff for further Chakra Connection (involving techniques used along the body, screening via telephone. If the person was eligible, appoint- intended to stimulate movement of vital energy through the ments were made to sign consent, complete pretest question- body), Mind Clearing (techniques performed on the head, naires and after completion, obtain randomized group status.
intended to stimulate mental relaxation), and Chakra Spread Inclusion criteria were as follows: (1) female or male subjects (an advanced technique utilized by HT practitioners and gener- 18 years or older, (2) postdeployment from a combat zone, (3) ally reserved for patients with more severe symptoms, intended referred by Camp Pendleton clinician, and (4) identified by to promote deep healing for emotional and/or physical pain).
postdeployment health reassessment to have PTSD symptoms GI is a complementary therapy that utilizes visualization (as described above). Exclusion criteria were as follows: (1) to induce a state of deep relaxation. The GI recording (CD) Currently pregnant or nursing, (2) currently using HT or GI used in this study was specifically for use in PTSD (Healing from other sources, and (3) inability to sign informed consent.
Trauma (PTSD)—Healthy Journeys by Belleruth Naparstek).
The study screened 205 potential participants; of these, 123 This recording does not utilize imagined exposure but uses were eligible and enrolled in the study.
imagery and affirmations to enhance relaxation, reduce negativeemotions associated with PTSD (such as terror and shame), Overview of Research Design and promote healthy self-esteem and sense of protection.
This was a Phase 2, two-armed, RCT with one arm random- Participants randomized to the HT+GI group received ized to receive HT+GI and one arm randomized to a TAU 6 sessions of HT over a 3-week period (two sessions per week).
control group. Each participant was studied over a 1-month Each session was of 1 hour's duration and consisted of the period. Although follow-up assessment was originally planned participant lying fully clothed on a massage table, listening for this study, it was not possible as the active duty study to the GI CD, whereas the practitioner provided HT. After the MILITARY MEDICINE, Vol. 177, September 2012 Delivered by Publishing Technology to: ProQuest IP: on: Tue, 04 Sep 2012 21:03:21 Copyright (c) Association of Military Surgeons of the U.S. All rights reserved.
HT+GI for PTSD in Returning Military first HT+GI session, participants were given the GI recording status, number of children, years of service, number of times on CD and encouraged to listen to the GI recording at least deployed in a combat zone, alcohol use, and PTSD medication once daily or more often if desired. Participant's adherence use) were examined for potential correlations with outcome to listening to the GI CD was not assessed.
variables and entered as covariates in the analysis if associatedwith the dependent variable at p < 0.05. Intent-to-treat analyses were performed using the last-score carried forward approach;this approach was compared to per-protocol analyses (using Primary Outcome Measure—PTSD Symptoms (PCL-Military) casewise deletion) to confirm agreement in results. Alpha was The primary outcome examined was PTSD symptoms as set to 0.05; to avoid Type 1 error with multiple comparisons, indexed by the gold-standard PTSD Checklist (PCL)-Military.
alphas for secondary outcome measures comprised of separate This reliable and valid17 17-item self-report measure was subscales (i.e., SF-36 and Cook–Medley Hostility Inventory) developed by the National Center for PTSD and measures were Bonferroni corrected (0.05/2 or 0.025 for SF-36 MCS PTSD symptom severity in reference to stressful military and PCS scales, and 0.05/3 or 0.016 for Cook–Medley Cyni- experiences. Scores range from 17 to 85. A clinical cutoff cism, Hostile Affect, and Aggressiveness scales). Effect sizes score of 50 has been established as an optimal cut point for were calculated using absolute values of Cohen's d, using PTSD diagnosis using this measure.18 the standard formula: d (Mpost, E − Mpre, E)/SDpre, E − (Mpost, E − Mpre, C)/SDpre, C.
Secondary Outcome Measures—Depression (BDI), Quality of Life(SF-36), and Hostility (Cook–Medley Hostility Inventory) Given recent data indicating the clustering of depression and poorer quality of life as well as higher hostility with higher Figure 1 depicts the Consolidated Standards of Reporting Trials PTSD in military populations,19,20 we examined potential (CONSORT) flow diagram for participants through the study.
changes in depression, quality of life, and hostility as second- Of the 123 participants, there were 21 dropouts for a total ary outcomes. Depression was measured via the Beck Depres- attrition rate of 17%. Of these dropouts, 15 were in the control sion Inventory (BDI-II), a highly reliable and valid 21-item group (28.3% attrition rate) and 6 were in the treatment group self-report scale that measures depressive symptomatology (12.2% attrition rate). No adverse effects were reported.
including sadness, feelings of guilt, perceptions of self-worth,suicidal ideation, and changes in appetite and body weight,among other characteristics.21 Scores range from 0 to 63;scores above 18 indicate likelihood of major depressive dis-order (MDD).22 Quality of life was measured using the gold-standard SF-36 measure, which has been found to have highreliability and validity23 and is widely used to examine bothmental quality of life (summated via the mental componentscore [MCS]) as well as physical quality of life (summated viathe physical component score [PCS]). Scores range from 0to 100 with higher scores representing higher quality of life.
Norms for the general U.S. population for the PCS and MCSare 50.24 Finally, we utilized the reliable and valid Cook–Medley Hostility Inventory, to measure the derived scales ofhostile affect, cynicism, and aggressive responding.25 Statistical Analysis Strategy To determine sample size, a power analysis using the pro-gram G-Power was performed for the primary variable ofinterest (PCL-Military), using means and SDs derived fromthe instrument's standardization report, a = 0.05, and apower of 0.90. A mean initial PCL score of 64 was hypothe-sized based on previous norms. For a hypothesized reductionof 10% in the mean PCL score from 64 to 58, a total of 126(63 subjects per group) were needed. Data were analyzed viarepeated measures analysis of covariance (RMANCOVA),using SPSS 17.0. Outcome data were examined for potentialoutliers and verification of normal distribution. Demographicand behavioral characteristics (age, gender, ethnicity, marital CONSORT patient flow diagram.
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HT+GI for PTSD in Returning Military Demographic/behavioral characteristics of participants are 23.0, p < 0.0005), with PTSD symptoms markedly declining for found in Table I. All data were normally distributed with no the HT+GI group (Cohen's d = 0.85). This group by time inter- outliers. Intent to treat analyses based on RMANCOVA were action is depicted in Figure 2.
conducted using relevant covariates in each analysis. Meansand SDs for primary and secondary outcome measures are Secondary Outcomes—Depression, Quality of Life, depicted in Table II.
Alcohol use was significantly positively correlated with Primary Outcome—PTSD Symptoms BDI depression scores and was entered as a covariate in PTSD medication use was significantly positively correlated with RMANCOVA analyses. Results indicated a significant increased PCL scores and entered as a covariate in analysis.
group + time interaction (F 15.3, p < 0.0005), with RMANCOVA analysis for PCL scores controlling for medica- the HT+GI group showing notable decreases in depression tion use indicated a significant group + time interaction (F over time (Cohen's d = 0.70).
For quality of life, PTSD medication use was significantly Baseline Medical and Demographic Characteristics of associated with poorer SF-36 mental health as indexed by 123 Active Duty Personnel: Means (Range) for Continuous MCS scores, and alcohol use was significantly positively Variables and Percentages for Categorical Variables correlated with poorer physical health as indexed by PCSscores. These were entered as covariates in subsequent ana- lyses. RMANCOVA for MCS scores indicated a significant group + time interaction (F 10.0, p = 0.002), with Military Service, Years those in the HT+GI group showing increases in mental health quality of life over time (Cohen's d = 0.58). Results for the PCS scores when controlling for alcohol use were not signif- icant when Bonferroni corrected ( p = 0.04, Cohen's d = 0.2).
For Cook–Medley Hostility scales, increasing age, years of military service, and number of children were negatively asso- ciated with Cynicism; ethnicity was significantly associated with Hostile Affect, and increasing age and number of children were negatively associated with Aggressive Responding. These Asian/Pacific Islander were entered as covariates in respective analyses. Results indi- cated a significant group by time interaction for cynicism 11.2, p = 0.001, Cohen's d = 0.49), a trend for hostile 5.3, p = 0.02, Cohen's d = 0.58), and no effect for aggressive responding (p Number of Children = 0.67, Cohen's d = 0.03).
Currently Use Medications To verify that our use of the last-score carried forward approach for intention-to-treat analyses was appropriate, we conducted per-protocol analyses (RMANCOVA without sub- stitution of missing values using casewise deletion). Results Means (95% Confidence Intervals) for Outcome Variables by Group HT+GI+TAU (n = 68) RMANCOVA p-Value; Effect Size (Cohen's d) 54.0 (50.9, 57.2) 55.6 (52.1, 59.1) 40.7 (37.0, 44.2) 52.0 (48.0, 56.0) p < 0.0005; Cohen's d = 0.85 BDI Preintervention 25.6 (22.9, 28.4) 26.8 (23.7, 29.8) BDI Postintervention 16.4 (13.5, 19.4) 23.9 (20.6, 27.1) p < 0.0005; Cohen's d = 0.70 SF-36 PCS Preintervention 48.5 (46.1, 50.1) 48.0 (45.5, 50.6) SF-36 PCS Postintervention 49.9 (47.7, 52.1) 47.2 (44.7, 49.7) p = 0.04; Cohen's d = 0.20 SF-36 MCS Preintervention 30.3 (27.6, 33.1) 30.1 (27.1, 33.3) SF-36 MCS Postintervention 39.6 (36.5, 42.6) 32.9 (29.5, 36.3) p = 0.002; Cohen's d = 0.58 CM Cynicism Preintervention CM Cynicism Postintervention p = 0.001; Cohen's d = 0.49 CM Hostile Affect Preintervention CM Hostile Affect Postintervention p = 0.02; Cohen's d = 0.58 CM Aggressiveness Preintervention CM Aggressiveness Postintervention p = 0.67; Cohen's d = 0.03 CM = Cook–Medley.
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HT+GI for PTSD in Returning Military less explicitly focused on "mental disorder" may serve toreduce soldiers' potential stigmatizing beliefs about mentalhealth care (ostensibly through the positive perception anddevelopment of a patient–practitioner relationship) and pos-sibly provide them with tools to better cope with PTSDsymptoms as they emerge (potentially through enhancementof the relaxation response and increased sense of safety).
However, specific dose-response effects and the potential long-term effectiveness of this intervention on maintaining reductionsin PTSD symptoms are unclear. In contrast, the short- andlong-term efficacy of gold-standard approaches (such as expo-sure, cognitive behavioral therapy, and eye movement desen-sitization and reprocessing) to reducing and preventingrelapse of PTSD has been demonstrated.27,28 However, initi-ation of treatment and adherence to these therapies is noted tobe problematic in this population.29 A future direction forstudies in this area may be to directly examine the effective-ness of complementary medicine interventions on increasingadherence and positive clinical outcomes in response to other Group + time interaction for primary outcome variable (PCL- gold-standard treatments for PTSD and/or depression. One Military symptom scores), controlling for the significant covariate of PTSD might examine the potential mediating roles of decreased stig- medication use.
matizing beliefs and enhanced sense of safety, on complemen-tary medicine interventions' effects on adherence and were identical in terms of significance/nonsignificance of outcomes to gold-standard approaches for eliminating PTSD.
outcomes with comparable effect sizes, suggesting that the There are notable limitations to this study, including lack intention-to-treat analyses in this study were appropriate.
of follow-up (which was not feasible for this studied popula-tion), lack of adherence monitoring (for listening to the GI recordings outside of sessions), and lack of an active compar- This phase 2 RCT examined the effectiveness of a combined ison group. The study also had notably low representation complementary medicine intervention (HT+GI) compared to among certain ethnic minority groups; although, this may be TAU on PTSD and related symptoms in active duty military.
partly because of the lack of representation of these groups in Results indicate significant and substantial reductions in PTSD the geographical area, it may also be due to selection bias.
symptoms, depression, and cynicism as well as improved Some may point to the combining of the interventions of HT mental quality of life for those receiving the intervention.
and GI as a limitation. However, this study was aimed at Clinical cutoffs for PTSD diagnosis using the PCL are 50,18 determining feasibility and effectiveness of the combined and changes of 10 to 20 points are considered to be clinically intervention, not mechanisms of action for each component.
significant.26 The drop in PTSD symptoms for the intervention The decision to combine the two complementary medicine group by 14 points (from 54.7 to 40.7) thus has clinical as well interventions was based on consultations with expert practi- as statistical significance. A score of 18 on the BDI has been tioners who, based on prior experience with similar pop- found to be optimal in predicting major depressive disorder22; ulations, suggested that the combination of both biofield thus, the pre–post drop from 26.1 to 16.4 for the intervention healing and GI would synergize to provide maximum effec- group also suggests a clinically meaningful reduction in tiveness in reducing PTSD symptoms in the following man- depression. Although these results may generalize to other ner: the GI, which focuses on creating a sense of spiritual active duty military with combat-related PTSD symptoms, it safety and deep relaxation, provides an atmosphere where the is unclear how these results may generalize to other military participant could allow him or herself to safely and deeply populations (e.g., veterans with continued PTSD).
engage into a relaxation response and therefore also gain The decrease in cynicism (with a medium effect size), for maximum benefit from the interaction with the HT practi- participants receiving the intervention, is particularly note- tioner. The continued pairing of this relaxation response with worthy. Reports of higher cynicism are common among the positive and trusting interaction with a health care pro- active duty combat soldiers and likely relate to issues of fessional and invitation for spiritual grounding and self- perceived stigma and negative beliefs about traditional men- connection would further the possibility of the mind–body to tal health care (i.e., clinical psychology and psychiatry) that "let go" of the residual conditioning of previous trauma, and appear to hinder these soldiers from seeking help from men- thus reduce PTSD symptoms. The underlying rationale for tal health sources for PTSD. Our data support the notion that combining the two techniques is not unlike the underlying engagement in a complementary medicine approach that is rationale for many psychotherapeutic approaches, where it is MILITARY MEDICINE, Vol. 177, September 2012 Delivered by Publishing Technology to: ProQuest IP: on: Tue, 04 Sep 2012 21:03:21 Copyright (c) Association of Military Surgeons of the U.S. All rights reserved.
HT+GI for PTSD in Returning Military understood that establishing trust, rapport, and often also a 2. Milliken CS, Auchterlonie JL, Hoge CW: Longitudinal assessment of sense of relaxation are fundamental to the therapy process— mental health problems among active and reserve component soldiersreturning from the Iraq war. JAMA 2007; 298(18): 2141–8.
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8. Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL: HT+GI vs. TAU. Effect sizes found for this intervention are Combat duty in Iraq and Afghanistan, mental health problems and bar- comparable and sometimes superior to those reported in the riers to care. US Army Med Dep J 2008; 7–17.
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would also like to acknowledge Elizabeth Fraser, BSN, CHTP and Jessie 19. Analysis HP and E (HPA&E): 2003-2004 Active Duty Health Study: Kobylski, RN, who provided the Healing Touch Interventions, and Eva Revised Final Report. Falls Church, VA, TRICARE Management Stuart, RN, who was the Research Co-ordinator.
Activity, 2006.
We thank our funders Donald and Ruth Taylor as well as Samueli Institute.
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RANDOMISED CONTROLLED CLINICAL TRIAL Marco Esposito, Carlo Barausse, Roberto Pistilli, Vittorio Checchi, Michele Diazzi, Maria Rosaria Gatto, Pietro Felice Posterior jaws rehabilitated with partial prostheses supported by 4.0 x 4.0 mm or by longer implants: Four-month post-loading data from a randomised Marco Esposito, DDS, PhDFreelance researcher and Associated Professor, Department of Biomaterials,

DENUNCIA CIUDADANA Señora Ruth Obando, Delegada Departamental del Ministerio del Ambiente y Recursos Naturales del Departamento de Chontales. Nosotros los abajo firmantes, ciudadanos y ciudadanas nicaragüenses todos mayores de edad, domiciliados en los municipios de Santo Domingo y Managua amparados en el artículo 2 de la Ley 217, Ley General de Medio Ambiente y los Recursos Naturales, que establece que toda