Non-trauma-focused meditation versus exposure therapy in veterans with post-traumatic stress disorder: a randomised controlled trial.

BACKGROUND: Post-traumatic stress disorder (PTSD) is a complex and difficult-to-treat disorder, affecting 10-20% of military veterans. Previous research has raised the question of whether a non-trauma-focused treatment can be as effective as trauma exposure therapy in reducing PTSD symptoms. This study aimed to compare the non-trauma-focused practice of Transcendental Meditation (TM) with prolonged exposure therapy (PE) in a non-inferiority clinical trial, and to compare both therapies with a control of PTSD health education (HE). METHODS: We did a randomised controlled trial at the Department of Veterans Affairs San Diego Healthcare System in CA, USA. We included 203 veterans with a current diagnosis of PTSD resulting from active military service randomly assigned to a TM or PE group, or an active control group of HE, using stratified block randomisation. Each treatment provided 12 sessions over 12 weeks, with daily home practice. TM and HE were mainly given in a group setting and PE was given individually. The primary outcome was change in PTSD symptom severity over 3 months, assessed by the Clinician-Administered PTSD Scale (CAPS). Analysis was by intention to treat. We hypothesised that TM would show non-inferiority to PE in improvement of CAPS score (Δ=10), with TM and PE superior to PTSD HE. This study is registered with ClinicalTrials.gov, number NCT01865123. FINDINGS: Between June 10, 2013, and Oct 7, 2016, 203 veterans were randomly assigned to an intervention group (68 to the TM group, 68 to the PE group, and 67 to the PTSD HE group). TM was significantly non-inferior to PE on change in CAPS score from baseline to 3-month post-test (difference between groups in mean change -5·9, 95% CI -14·3 to 2·4, p=0·0002). In standard superiority comparisons, significant reductions in CAPS scores were found for TM versus PTSD HE (-14·6 95% CI, -23·3 to -5·9, p=0·0009), and PE versus PTSD HE (-8·7 95% CI, -17·0 to -0·32, p=0·041). 61% of those receiving TM, 42% of those receiving PE, and 32% of those receiving HE showed clinically significant improvements on the CAPS score. INTERPRETATION: A non-trauma-focused-therapy, TM, might be a viable option for decreasing the severity of PTSD symptoms in veterans and represents an efficacious alternative for veterans who prefer not to receive or who do not respond to traditional exposure-based treatments of PTSD. FUNDING: Department of Defense, US Army Medical Research.

Individual Treatment of Posttraumatic Stress Disorder Using Mantram Repetition: A Randomized Clinical Trial.

OBJECTIVE: Previous studies suggest that group "mantram" (sacred word) repetition therapy, a non-trauma-focused complementary therapy for posttraumatic stress disorder (PTSD), may be an effective treatment for veterans. The authors compared individually delivered mantram repetition therapy and another non-trauma-focused treatment for PTSD. METHOD: The study was a two-site, open-allocation, blinded-assessment randomized trial involving 173 veterans diagnosed with military-related PTSD from two Veterans Affairs outpatient clinics (January 2012 to March 2014). The mantram group (N=89) learned skills for silent mantram repetition, slowing thoughts, and one-pointed attention. The comparison group (N=84) received present-centered therapy, focusing on currently stressful events and problem-solving skills. Both treatments were delivered individually in eight weekly 1-hour sessions. The primary outcome measure was change in PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale (CAPS) and by self-report. Secondary outcome measures included insomnia, depression, anger, spiritual well-being, mindfulness, and quality of life. Intent-to-treat analysis was conducted using linear mixed models. RESULTS: The mantram group had significantly greater improvements in CAPS score than the present-centered therapy group, both at the posttreatment assessment (between-group difference across time, -9.98, 95% CI=-3.63, -16.00; d=0.49) and at the 2-month follow-up (between-group difference, -9.34, 95% CI=-1.50, -17.18; d=0.46). Self-reported PTSD symptom severity was also lower in the mantram group compared with the present-centered therapy group at the posttreatment assessment, but there was no difference at the 2-month follow-up. Significantly more participants in the mantram group (59%) than in the present-centered therapy group (40%) who completed the 2-month follow-up no longer met criteria for PTSD (p<0.04). However, the percentage of participants in the mantram group (75%) compared with participants in the present-centered therapy group (61%) who experienced clinically meaningful changes (≥10-point improvements) in CAPS score did not differ significantly between groups. Reductions in insomnia were significantly greater for participants in the mantram group at both posttreatment assessment and 2-month follow-up. CONCLUSIONS: In a sample of veterans with PTSD, individually delivered mantram repetition therapy was generally more effective than present-centered therapy for reducing PTSD symptom severity and insomnia.

Telehealth Versus In-Person Acceptance and Commitment Therapy for Chronic Pain: A Randomized Noninferiority Trial.

The purpose of this randomized noninferiority trial was to compare video teleconferencing (VTC) versus in-person (IP) delivery of an 8-week acceptance and commitment therapy (ACT) intervention among veterans with chronic pain (N = 128) at post-treatment and at 6-month follow-up. The primary outcome was the pain interference subscale of the Brief Pain Inventory. Secondary outcomes included measures of pain severity, mental and physical health-related quality of life, pain acceptance, activity level, depression, pain-related anxiety, and sleep quality. In intent to treat analyses using mixed linear effects modeling, both groups exhibited significant improvements on primary and secondary outcomes, with the exception of sleep quality. Further, improvements in activity level at 6-month follow-up were significantly greater in the IP group. The noninferiority hypothesis was supported for the primary outcome and several secondary outcomes. Treatment satisfaction was similar between groups; however, significantly more participants withdrew during treatment in the VTC group compared with the IP group, which was moderated by activity level at baseline. These findings generally suggest that ACT delivered via VTC can be as effective and acceptable as IP delivery for chronic pain. Future studies should examine the optimal delivery of ACT for patients with chronic pain who report low levels of activity. This trial was registered at ClinicalTrials.gov (NCT01055639). PERSPECTIVE: This study suggests that ACT for chronic pain can be implemented via VTC with reductions in pain interference comparable with IP delivery. This article contains potentially important information for clinicians using telehealth technology to deliver psychosocial interventions to individuals with chronic pain.

Efficacy of the Mantram Repetition Program for Insomnia in Veterans With Posttraumatic Stress Disorder: A Naturalistic Study.

Statistics show that more than 80% of Veterans mention posttraumatic stress disorder (PTSD)-related symptoms when seeking treatment. Sleep disturbances and nightmares are among the top 3 presenting problems. Current PTSD trauma-focused therapies generally do not improve sleep disturbances. The mantram repetition program (MRP), a mind-body-spiritual intervention, teaches a portable set of cognitive-spiritual skills for symptom management. The aim of this study was to evaluate the efficacy of the MRP on insomnia in Veterans with PTSD in a naturalistic, clinical setting. Results show that participation in the MRP significantly reduced insomnia, as well as decreased self-reported and clinician-assessed PTSD symptom burden.

Design and rationale of a comparative effectiveness trial evaluating transcendental meditation against established therapies for PTSD.

BACKGROUND: Although meditation therapies such as the Transcendental Meditation (TM) technique are commonly used to assist with stress and stress-related diseases, there remains a lack of rigorous clinical trial research establishing the relative efficacy of these treatments overall and for populations with psychiatric illness. This study uses a comparative effectiveness design to assess the relative benefits of TM to those obtained from a gold-standard cognitive behavioral therapy for posttraumatic stress disorder (PTSD) in a Veteran population. METHODS AND DESIGN: This paper describes the rationale and design of an in progress randomized controlled trial comparing TM to an established cognitive behavioral treatment - Prolonged Exposure (PE) - and an active control condition (health education [HE]) for PTSD. This trial will recruit 210 Veterans meeting DSM-IV criteria for PTSD, with testing conducted at 0 and 3 months for PTSD symptoms, depression, mood disturbance, quality of life, behavioral factors, and physiological/biochemical and gene expression mechanisms using validated measures. The study hypothesis is that TM will be noninferior to PE and superior to HE on changes in PTSD symptoms, using the Clinician Administered PTSD Scale (CAPS). DISCUSSION: The described study represents a methodologically rigorous protocol evaluating the benefits of TM for PTSD. The projected results will help to establish the overall efficacy of TM for PTSD among Veterans, identify bio-behavioral mechanisms through which TM and PE may improve PTSD symptoms, and will permit conclusions regarding the relative value of TM against currently established therapies for PTSD.

Diminished vagal activity and blunted diurnal variation of heart rate dynamics in posttraumatic stress disorder.

Affected autonomic heart regulation is implicated in the pathophysiology of cardiovascular diseases and is associated with posttraumatic stress disorder (PTSD). However, although sympathetic hyperactivation has been repeatedly shown in PTSD, research has neglected parasympathetic function. The objective of this study is the long-term assessment of heart rate (HR) dynamics and its diurnal changes as an index of autonomic imbalance in PTSD. Since tonic parasympathetic activity underlies long-range correlation of heartbeat interval fluctuations in the healthy state, we included nonlinear (unifractal) analysis as an important and sensitive readout to assess functional alterations. We conducted electrocardiogram recordings over a 24-h period in 15 deployed male subjects with moderate to high levels of combat exposure (PTSD: n = 7; combat controls: n = 8) in the supine position. HR dynamics were assessed in two 5-h sub-epochs in the time and frequency domains, and by nonlinear analysis based on detrended fluctuation analysis. Psychiatric symptoms were assessed using structured interviews, including the Clinician Administered PTSD Scale. Subjects with PTSD showed significantly higher baseline HR, higher LF/HF ratio in the frequency domain, blunted differences between day and night-time measures, as well as a higher scaling coefficient αfast during the day, indicating diminished tonic parasympathetic activity. Diminished diurnal differences and blunted tonic parasympathetic activity altering HR dynamics suggest central neuroautonomic dysregulation that could represent a possible link to increased cardiovascular disease in PTSD.

Metabolic syndrome: relative risk associated with post-traumatic stress disorder (PTSD) severity and antipsychotic medication use.

BACKGROUND: In recent years, numerous lines of converging evidence have revealed an association between post-traumatic stress disorder (PTSD) and impaired physical health outcomes, including cardiovascular disease and metabolic syndrome. Although these findings have been interpreted as indicating a direct association of PTSD with metabolic syndrome and obesity, previous studies have not addressed the important confound of antipsychotic drug usage in this population. Second generation antipsychotic medications themselves are associated with metabolic syndrome and obesity, and it is unclear whether the common utilization of these drugs in PTSD may account for some if not all of the observed metabolic problems. OBJECTIVE: The present study examined the relative contributions of PTSD severity and use of antipsychotic medications to risk of metabolic syndrome among veterans. METHOD: Cross-sectional clinical data, including five factors representing metabolic syndrome, psychiatric diagnoses, and medications were gathered from 253 veterans enrolling in mental health services. We used a logistic regression model to measure the relative association of antipsychotic medication use and PTSD severity on risk of metabolic syndrome. RESULTS: We found that antipsychotic medication usage was not uniquely associated with elevated risk of metabolic syndrome (Wald = 0.30, ns) when PTSD severity and other sociodemographic, psychiatric, and behavioral variables were accounted for. Furthermore, PTSD severity continued to be a significant and unique predictor of risk for metabolic syndrome (Wald = 4.04, p < 0.05). CONCLUSIONS: These findings suggest that chronic and moderately severe PTSD, independent of antipsychotic medications, is associated with increased risk of metabolic syndrome.

The comorbidity of self-reported chronic fatigue syndrome, post-traumatic stress disorder, and traumatic symptoms.

BACKGROUND: Data from primary care and community samples suggest higher rates of post-traumatic stress disorder (PTSD) among individuals with chronic fatigue syndrome (CFS). OBJECTIVE: This study investigated the co-occurrence of CFS, PTSD, and trauma symptoms and assessed the contribution of familial factors to the association of CFS with lifetime PTSD and current traumatic symptoms. METHOD: Data on lifetime CFS and PTSD, as measured by self-report of a doctor's diagnosis of the disorder, and standardized questionnaire data on traumatic symptoms, using the Impact of Events Scale (IES), were obtained from 8544 female and male twins from the community-based University of Washington Twin Registry. RESULTS: Lifetime prevalence of CFS was 2% and lifetime prevalence of PTSD was 4%. Participants who reported a history of PTSD were over eight times more likely to report a history of CFS. Participants with scores ≥ 26 on the IES were over four times more likely to report CFS than those who had scores ≤ 25. These associations were attenuated but remained significant after adjusting for familial factors through within-twin pair analyses. CONCLUSION: These results support similar findings that a lifetime diagnosis of CFS is strongly associated with both lifetime PTSD and current traumatic symptoms, although familial factors, such as shared genetic and environmental contributions, played a limited role in the relationship between CFS, PTSD, and traumatic symptoms. These findings suggest that future research should investigate both the familial and the unique environmental factors that may give rise to both CFS and PTSD.

Female veterans of the OEF/OIF conflict: concordance of PTSD symptoms and substance misuse.

This study examined the post-deployment rates of comorbid PTSD and substance abuse in a cohort of female veterans who served in Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF). Female OEF/OIF veterans and reservists (N=36) completed a battery of assessments as part of a larger study. Of the 36 participants, 11 (31%) screened positive for posttraumatic stress disorder (PTSD), 17 (47%) screened positive for high-risk drinking and 2 (6%) screened positive for drug abuse. Higher scores on measures of alcohol and drug use predicted positive PTSD status (p < or = 0.01) and alcohol misuse was significant in explaining unique variance of PTSD status (p < or = 0.05). Our findings suggest a trend toward increased problematic drinking among female OEF/OIF veterans and reservists and a relationship between substance misuse and PTSD. Future research should investigate needs for gender-specific PTSD and substance-abuse treatment needs.

PTSD, combat injury, and headache in Veterans Returning from Iraq/Afghanistan.

OBJECTIVE: To examine the relationship between posttraumatic stress disorder, combat injury, and headache in Operation Iraqi Freedom and Operation Enduring Freedom veterans at the VA San Diego Healthcare System. BACKGROUND: Previous investigations suggest that a relationship between posttraumatic stress disorder and primary headache disorders exists and could be complicated by the contribution of physical injury, especially one that results in loss of consciousness. These associations have not been systematically examined in Operation Iraqi Freedom and Operation Enduring Freedom veterans. METHODS: In this observational cross-sectional study, a battery of self-report, standardized questionnaires was completed by 308 newly registered veterans between March and October 2006. The Davidson Trauma Scale was used to determine the degree of posttraumatic stress disorder symptoms and combat-related physical injury was assessed by self-report. The presence of headache was based on a symptom checklist measure and self-reported doctor diagnoses. Logistic regression analysis was performed to predict presence of headache and determine odds ratios and 95% confidence intervals associated with demographic, military, in-theatre, and mental health characteristics. RESULTS: About 40% of the veterans met the criteria for posttraumatic stress disorder; 40% self-reported current headache, 10% reported a physician diagnosis of migraine, 12% a physician diagnosis of tension-type headache, and 6% reported both types of headache. Results from the logistic regression model indicated that combat-related physical injury (odds ratio: 2.25; 95% confidence interval: 1.17-4.33) and posttraumatic stress disorder (odds ratio: 4.13; 95% confidence interval: 2.44-6.99) were independent predictors of self-reported headache. Additional analyses found that veterans with both tension and migraine headache had higher rates of posttraumatic stress disorder (chi-square [d.f. = 3] = 15.89; P = .001) whereas veterans with migraine headache alone had higher rates of combat-related physical injury (chi-square [d.f. = 9] = 22.00; P = .009). CONCLUSION: Posttraumatic stress disorder and combat-related physical injury were related to higher rates of self-reported headache in newly returning veterans. Our finding that posttraumatic stress disorder and injury during combat are differentially related to migraine and tension-type headache, point to a complex relationship between physical and psychological trauma and headache. These findings have implications for a comprehensive approach to interventions for headache and the physical and psychological sequelae of trauma.

Trauma exposure, branch of service, and physical injury in relation to mental health among U.S. veterans returning from Iraq and Afghanistan.

Significant mental health symptoms are reported in troops deployed to Iraq and Afghanistan (OEF/OIF). Symptomatic troops are more likely to be discharged and become eligible for Department of Veterans Affairs (DVA) care. Prevalence and predictors of mental health symptoms were assessed in 339 OEF/OIF veterans and reservists registering at the San Diego DVA. Participants completed self-report questionnaires assessing combat exposure, posttraumatic stress disorder (PTSD) symptom frequency and severity, depression, and substance and alcohol abuse. A minority of participants (36%) did not screen positive for mental health symptoms; the remainder met threshold for caseness of PTSD, depression, or substance and alcohol abuse. Using a hierarchical logistic regression model, gender, age, race, and rank were not significantly related to PTSD caseness, whereas most recent branch of service and report of injury during combat were. Follow-up analyses revealed that trauma history and combat exposure varied by branch of service. Knowledge of base rates and vulnerability factors can aid in rapid detection of "at risk" individuals.

The association of posttraumatic stress disorder and metabolic syndrome: a study of increased health risk in veterans.

BACKGROUND: There is accumulating evidence for a link between trauma exposure, posttraumatic stress disorder (PTSD) and diminished health status. To assess PTSD-related biological burden, we measured biological factors that comprise metabolic syndrome, an important established predictor of morbidity and mortality, as a correlate of long-term health risk in PTSD. METHODS: We analyzed clinical data from 253 male and female veterans, corresponding to five factors linked to metabolic syndrome (systolic and diastolic blood pressure, waist-to-hip ratio and fasting measures of high-density lipoprotein (HDL) cholesterol, serum triglycerides and plasma glucose concentration). Clinical cut-offs were defined for each biological parameter based on recommendations from the World Health Organization and the National Cholesterol Education Program. Controlling for relevant variables including sociodemographic variables, alcohol/substance/nicotine use and depression, we examined the impact of PTSD on metabolic syndrome using a logistic regression model. RESULTS: Two-fifths (40%) of the sample met criteria for metabolic syndrome. Of those with PTSD (n = 139), 43% met criteria for metabolic syndrome. The model predicted metabolic syndrome well (-2 log likelihood = 316.650, chi-squared = 23.731, p = 0.005). Veterans with higher severity of PTSD were more likely to meet diagnostic criteria for metabolic syndrome (Wald = 4.76, p = 0.03). CONCLUSION: These findings provide preliminary evidence linking higher severity of PTSD with risk factors for diminished health and increased morbidity, as represented by metabolic syndrome.

Regular walking and long-term maintenance of outcomes after pulmonary rehabilitation.

BACKGROUND: Empirical evidence supports the role of exercise as part of pulmonary rehabilitation in improving symptoms of breathlessness (dyspnea), health-related quality of life, and exercise tolerance among patients with chronic lung disease. However, many studies show that these initial benefits tend to diminish 12 to 18 months after rehabilitation. Given the importance of exercise (ie, walking) during rehabilitation, we examined whether patient adherence to regular walking enhanced the long-term maintenance of functional benefits gained from an 8-week pulmonary rehabilitation program. METHODS: One hundred twenty-three patients with moderate to severe chronic lung disease completed an 8-week pulmonary rehabilitation program and participated in a 12-month maintenance intervention trial. Measures of weekly walking, lung function, self-efficacy for walking, dyspnea during activities of daily living, exercise capacity (6-minute walk test, 6MW), perceived breathlessness after the 6MW, and health-related quality of life were obtained at postrehabilitation, and at 6, 12, and 24 months after completing pulmonary rehabilitation. Regular walkers were defined as those active on most days or every single day of the week on the average throughout the 24-month period, whereas irregular walkers walked on some days, rarely, or not at all. RESULTS: The effects of the maintenance program on average frequency of walking were nonsignificant, with 44% of the maintenance patients and 38% of the standard care patients classified as regular walkers. There were no significant differences between walking groups on gender, healthcare utilization over the 24-month follow-up period, and postrehabilitation measures of lung function, 6MW distance, perceived breathlessness after 6MW, health-related quality of life, dyspnea, or age. Repeated measures analyses of variance using a 2 x 4 mixed model approach were applied to examine group differences and changes in outcomes over time. Overall, participants decreased in 6MW distance (P <.001), reported increases in perceived breathlessness after the 6MW (P <.05), and decreased in overall health-related quality of life (P <.001) from postrehabilitation to 24 months. Regular walkers reported significantly better health-related quality of life (P <.05) as compared to irregular walkers, averaging across time points. Irregular walkers declined significantly more than regular walkers on measures of shortness of breath during activities of daily living (P <.01) and walking self-efficacy (P <.001) from postrehabilitation to 24 months. CONCLUSIONS: Findings suggest that participation in regular exercise such as walking after completing pulmonary rehabilitation is associated with slower declines in overall health-related quality of life and walking self-efficacy as well as less progression of dyspnea during activities of daily living. Regular exercise after rehabilitation may be protective against increases in dyspnea symptoms and perceived limitations in walking which are both characteristic of progressing chronic lung disease.