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Background: The impact of posttraumatic stress disorder (PTSD) is substantial and often results in pervasive functional impairments. Although evidence-based treatments for PTSD are established, there remains room for improvement as many individuals continue to meet diagnostic criteria even after successful treatment completion. Cannabidiol (CBD) has attracted considerable attention based on its potential to treat a myriad of health conditions. CBD may decrease anxiety and facilitate extinction learning processes, two critical targets of trauma-focused psychotherapies. We present the design and methods for a pilot randomized clinical trial to examine the combination of CBD and prolonged exposure for PTSD. Methods: Participants (n = 24) will be randomized to CBD or placebo for 18 days delivered in combination with ten daily prolonged exposure sessions over two weeks. The study medication will be Epidiolex® (250 mg BID). The PTSD Checklist for DSM-5 will be the primary outcome to assess PTSD severity at baseline, during treatment, and at 1-month follow-up. Blood, saliva, and heart rate will be collected during treatment to assess intervention effects on biological outcomes related to PTSD and the endocannabinoid system. Results: Consistent with the purpose of a pilot, our goals are to evaluate the feasibility of study procedures, safety of the intervention, and the preliminary effect of CBD to inform a larger trial. Descriptive and inferential statistics will be used to address study aims. Conclusion: Findings will inform decision making on combining CBD with behavioral interventions for PTSD to enhance outcomes and mitigate the morbidity of this debilitating condition.

Posttraumatic headache (PTH) is a common debilitating condition arising from head injury and is highly prevalent among military service members and veterans with traumatic brain injury (TBI). Diagnosis and treatment for PTH is still evolving, and surprisingly little is known about the putative mechanisms that drive these headaches. This manuscript describes the design of a randomized clinical trial of two nonpharmacological (i.e., behavioral) interventions for posttraumatic headache. Design of this trial required careful consideration of PTH diagnosis and inclusion criteria, which was challenging due to the lack of standard clinical characteristics in PTH unique from other types of headaches. The treatments under study differed in clinical focus and dose (i.e., number of treatment sessions), but the trial was designed to balance the treatments as well as possible. Finally, while the primary endpoints for pain research can vary from assessments of pain intensity to objective and subjective functional measures, this trial of PTH interventions chose carefully to establish clinically relevant endpoints and to maximize the opportunity to detect significant differences between groups with two primary outcomes. All these issues are discussed in this manuscript.

Objectives: Several recent studies have demonstrated that posttraumatic stress disorder (PTSD) and insomnia treatments are associated with significant reductions in suicidal ideation (SI) among service members. However, few investigations have evaluated the manner in which suicide risk changes over time among military personnel receiving PTSD or insomnia treatments. This paper describes the study protocol for a project with these aims: (1) explore potential genetic, clinical, and demographic subtypes of suicide risk in a large cohort of deployed service members; (2) explore subtype change in SI as a result of evidence-based psychotherapies for PTSD and insomnia; (3) evaluate the speed of change in suicide risk; and (4) identify predictors of higher- and lower-risk for suicide. Methods: Active duty military personnel were recruited for four clinical trials (three for PTSD treatment and one for insomnia treatment) and a large prospective epidemiological study of deployed service members, all conducted through the South Texas Research Organizational Network Guiding Studies on Trauma and Resilience (STRONG STAR Consortium). Participants completed similar measures of demographic and clinical characteristics and subsets provided blood samples for genetic testing. The primary measures that we will analyze are the Beck Scale for Suicide Ideation, Beck Depression Inventory, and the PTSD Checklist for DSM-IV. Discussion: Results from this study will offer new insights into the presence of discrete subtypes of suicide risk among active duty personnel, changes in risk over time among those subtypes, and predictors of subtypes. Findings will inform treatment development for military service members at risk for suicide.

Although there are a number of effective treatments for posttraumatic stress disorder (PTSD), there is a need to develop more efficient evidence-based PTSD treatments to address barriers to seeking and receiving treatment. Written exposure therapy (WET) is a potential alternative that is a 5-session treatment without any between-session assignments. WET has demonstrated efficacy, and low treatment dropout rates. However, prior studies with WET have primarily focused on civilian samples. Identifying efficient PTSD treatments for military service members is critical given the high prevalence of PTSD in this population. The current ongoing randomized clinical trial builds upon the existing literature by investigating whether WET is equally efficacious as Cognitive Processing Therapy (CPT) in a sample of 150 active duty military service members diagnosed with PTSD who are randomly assigned to either WET (n = 75) or CPT (n = 75). Participants are assessed at baseline and 10, 20, and 30 weeks after the first treatment session. The primary outcome measure is PTSD symptom severity assessed with the Clinician Administered PTSD Scale for DSM-5. Given the prevalence of PTSD and the aforementioned limitations of currently available first-line PTSD treatments, the identification of a brief, efficacious treatment that is associated with reduced patient dropout would represent a significant public health development. Keywords: Clinical trial, Posttraumatic stress disorder, Cognitive behavioral therapy, Written exposure therapy

Combat-related trauma exposures have been associated with increased risk for posttraumatic stress disorder (PTSD) and comorbid mental health conditions. Cognitive Processing Therapy (CPT) is a 12-session manualized cognitive-behavioral therapy that has emerged as one of the leading evidence-based treatments for combat-related PTSD among military personnel and veterans. However, rates of remission have been less in both veterans and active duty military personnel compared to civilians, suggesting that studies are needed to identify strategies to improve upon outcomes in veterans of military combat. There is existing evidence that varying the number of sessions in the CPT protocol based on patient response to treatment improves outcomes in civilians. This paper describes the rationale, design, and methodology of a clinical trial examining a variable-length CPT intervention in a treatment-seeking active duty sample with PTSD to determine if some service members would benefit from a longer or shorter dose of treatment, and to identify predictors of length of treatment response to reach good end-state functioning. In addition to individual demographic and trauma-related variables, the trial is designed to evaluate factors related to internalizing/externalizing personality traits, neuropsychological measures of cognitive functioning, and biological markers as predictors of treatment response. This study attempts to develop a personalized approach to achieving positive treatment outcomes for service members suffering from PTSD. Determining predictors of treatment response can help to develop an adaptable treatment regimen that returns the greatest number of service members to full functioning in the shortest amount of time. Keywords: Posttraumatic stress disorder, PTSD, Cognitive processing therapy, Military, Functioning