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Study design comparing written exposure therapy to cognitive processing therapy for PTSD among military service members: A noninferiority trial.

ABSTRACT: 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.

SUBMITTER: Sloan DM

PROVIDER: S-EPMC6926127 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Study design comparing written exposure therapy to cognitive processing therapy for PTSD among military service members: A noninferiority trial.

Sloan Denise M DM Marx Brian P BP Resick Patricia A PA Young-McCaughan Stacey S Dondanville Katherine A KA Mintz Jim J Litz Brett T BT Peterson Alan L AL

Contemporary clinical trials communications 20191210

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. Identify ...[more]

PMID: 31890987

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Project description:ImportancePosttraumatic stress disorder (PTSD) occurs more commonly among military service members than among civilians; however, despite the availability of several evidence-based treatments, there is a need for more efficient evidence-based PTSD treatments to better address the needs of service members. Written exposure therapy is a brief PTSD intervention that consists of 5 sessions with no between-session assignments, has demonstrated efficacy, and is associated with low treatment dropout rates, but prior randomized clinical trials of this intervention have focused on civilian populations.ObjectiveTo investigate whether the brief intervention, written exposure therapy, is noninferior in the treatment of PTSD vs the more time-intensive cognitive processing therapy among service members diagnosed with PTSD.Design, setting, and participantsThe study used a randomized, noninferiority design with a 1:1 randomization allocation. Recruitment for the study took place from August 2016 through October 2020. Participants were active-duty military service members diagnosed with posttraumatic stress disorder. The study was conducted in an outpatient setting for service members seeking PTSD treatment at military bases in San Antonio or Killeen, Texas.InterventionsParticipants received either written exposure therapy, which consisted of 5 weekly sessions, or cognitive processing therapy, which consisted of 12 twice-weekly sessions.Main outcomes and measuresParticipants were assessed at baseline and at 10, 20, and 30 weeks after the first treatment session. The primary outcome measure was PTSD symptom severity assessed with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Noninferiority was defined as the difference between the 2 groups being less than the upper bound of the 1-sided 95% CI-specified margin of 10 points on the CAPS-5.ResultsOverall, 169 participants were included in the study. Participants were predominantly male (136 [80.5%]), serving in the Army (167 [98.8%]), with a mean (SD) age of 34 (8) years. Eighty-five participants were randomly assigned to written exposure therapy, with 65 (76.5%) completing all treatment sessions, and 84 to cognitive processing therapy, with 47 (54.8%) completing all treatment sessions. Findings indicated that written exposure therapy was noninferior to cognitive processing therapy, with the largest difference in change in outcome between the treatment conditions of 3.96 points on the outcome measure. The 1-sided 95% CI upper limit was less than 10 points across time points in both groups and ranged from 4.59 at week 30 to 6.81 at week 10. Within-condition effect sizes ranged from a Cohen d of 0.48 for the written exposure therapy group in the intention-to-treat analysis at week 10 to 0.95 for the cognitive processing therapy group in the per-protocol analysis at week 10, and between-condition effect size ranged from 0.06 in the intention-to-treat analysis at week 30 to 0.22 in the per-protocol analysis at week 10.Conclusions and relevanceIn this randomized clinical trial, support was found for an effective and more efficient PTSD treatment approach for service members. Future research should determine who does and does not benefit from PTSD treatment to best maximize treatment outcomes.Trial registrationClinicalTrials.gov Identifier: NCT03033602.

Project description:BackgroundThe underlying molecular mechanisms of PTSD are largely unknown. Distinct expression signatures for PTSD have been found, in particular for immune activation transcripts. DNA methylation may be significant in the pathophysiology of PTSD, since the process is intrinsically linked to gene expression. We evaluated temporal changes in DNA methylation in select promoter regions of immune system-related genes in U.S. military service members with a PTSD diagnosis, pre- and post-diagnosis, and in controls.MethodsCases (n?=?75) had a post-deployment diagnosis of PTSD in their medical record. Controls (n?=?75) were randomly selected service members with no PTSD diagnosis. DNA was extracted from pre- and post-deployment sera. DNA methylation (%5-mC) was quantified at specific CpG sites in promoter regions of insulin-like growth factor 2 (IGF2), long non-coding RNA transcript H19, interleukin-8 (IL8), IL16, and IL18 via pyrosequencing. We used multivariate analysis of variance and generalized linear models to calculate adjusted means (adjusted for age, gender, and race) to make temporal comparisons of %5-mC for cases (pre- to post-deployment) versus controls (pre- to post-deployment).ResultsThere were significant differences in the change of %5-mC pre- to post-deployment between cases and controls for H19 (cases: +0.57%, controls: -1.97%; p?=?0.04) and IL18 (cases: +1.39%, controls: -3.83%; p?=?0.01). For H19 the difference was driven by a significant reduction in %5-mC among controls; for IL18 the difference was driven by both a reduction in %5-mC among controls and an increase in %5-mC among cases. Stratified analyses revealed more pronounced differences in the adjusted means of pre-post H19 and IL18 methylation differences for cases versus controls among older service members, males, service members of white race, and those with shorter deployments (6-12?months).ConclusionIn the study of deployed personnel, those who did not develop PTSD had reduced %5-mC levels of H19 and IL18 after deployment, while those who did develop PTSD had increased levels of IL18. Additionally, pre-deployment the people who later became cases had lower levels of IL18 %5-mC compared with controls. These findings are preliminary and should be investigated in larger studies.

Project description:To detect cerebral microhemorrhages in military service members with chronic traumatic brain injury by using susceptibility-weighted magnetic resonance (MR) imaging. The longitudinal evolution of microhemorrhages was monitored in a subset of patients by using quantitative susceptibility mapping.The study was approved by the Walter Reed National Military Medical Center institutional review board and is compliant with HIPAA guidelines. All participants underwent two-dimensional conventional gradient-recalled-echo MR imaging and three-dimensional flow-compensated multiecho gradient-recalled-echo MR imaging (processed to generate susceptibility-weighted images and quantitative susceptibility maps), and a subset of patients underwent follow-up imaging. Microhemorrhages were identified by two radiologists independently. Comparisons of microhemorrhage number, size, and magnetic susceptibility derived from quantitative susceptibility maps between baseline and follow-up imaging examinations were performed by using the paired t test.Among the 603 patients, cerebral microhemorrhages were identified in 43 patients, with six excluded for further analysis owing to artifacts. Seventy-seven percent (451 of 585) of the microhemorrhages on susceptibility-weighted images had a more conspicuous appearance than on gradient-recalled-echo images. Thirteen of the 37 patients underwent follow-up imaging examinations. In these patients, a smaller number of microhemorrhages were identified at follow-up imaging compared with baseline on quantitative susceptibility maps (mean ± standard deviation, 9.8 microhemorrhages ± 12.8 vs 13.7 microhemorrhages ± 16.6; P = .019). Quantitative susceptibility mapping-derived quantitative measures of microhemorrhages also decreased over time: -0.85 mm(3) per day ± 1.59 for total volume (P = .039) and -0.10 parts per billion per day ± 0.14 for mean magnetic susceptibility (P = .016).The number of microhemorrhages and quantitative susceptibility mapping-derived quantitative measures of microhemorrhages all decreased over time, suggesting that hemosiderin products undergo continued, subtle evolution in the chronic stage.

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Study design comparing written exposure therapy to cognitive processing therapy for PTSD among military service members: A noninferiority trial.

Publications

Study design comparing written exposure therapy to cognitive processing therapy for PTSD among military service members: A noninferiority trial.

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