Adequate reporting of randomized, controlled trials (RCTs) is necessary to allow accurate critical appraisal of the validity and applicability of the results. The CONSORT (Consolidated Standards of Reporting Trials) Statement, a 22-item checklist and flow diagram, is intended to address this problem by improving the reporting of RCTs. However, some specific issues that apply to trials of nonpharmacologic treatments (for example, surgery, technical interventions, devices, rehabilitation, psychotherapy, and behavioral intervention) are not specifically addressed in the CONSORT Statement. Furthermore, considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement. Therefore, the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments. A consensus meeting of 33 experts was organized in Paris, France, in February 2006, to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments. The participants extended 11 items from the CONSORT Statement, added 1 item, and developed a modified flow diagram. To allow adequate understanding and implementation of the CONSORT extension, the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting. This extension, in conjunction with the main CONSORT Statement and other CONSORT extensions, should help to improve the reporting of RCTs performed in this field.

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Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration.

ContextTo promote early identification of mental health problems among combat veterans, the Department of Defense initiated population-wide screening at 2 time points, immediately on return from deployment and 3 to 6 months later. A previous article focusing only on the initial screening is likely to have underestimated the mental health burden.ObjectiveTo measure the mental health needs among soldiers returning from Iraq and the association of screening with mental health care utilization.Design, Setting, and ParticipantsPopulation-based, longitudinal descriptive study of the initial large cohort of 88 235 US soldiers returning from Iraq who completed both a Post-Deployment Health Assessment (PDHA) and a Post-Deployment Health Re-Assessment (PDHRA) with a median of 6 months between the 2 assessments.Main Outcome MeasuresScreening positive for posttraumatic stress disorder (PTSD), major depression, alcohol misuse, or other mental health problems; referral and use of mental health services.ResultsSoldiers reported more mental health concerns and were referred at significantly higher rates from the PDHRA than from the PDHA. Based on the combined screening, clinicians identified 20.3% of active and 42.4% of reserve component soldiers as requiring mental health treatment. Concerns about interpersonal conflict increased 4-fold. Soldiers frequently reported alcohol concerns, yet very few were referred to alcohol treatment. Most soldiers who used mental health services had not been referred, even though the majority accessed care within 30 days following the screening. Although soldiers were much more likely to report PTSD symptoms on the PDHRA than on the PDHA, 49% to 59% of those who had PTSD symptoms identified on the PDHA improved by the time they took the PDHRA. There was no direct relationship of referral or treatment with symptom improvement.ConclusionsRescreening soldiers several months after their return from Iraq identified a large cohort missed on initial screening. The large clinical burden recently reported among veterans presenting to Veterans Affairs facilities seems to exist within months of returning home, highlighting the need to enhance military mental health care during this period. Increased relationship problems underscore shortcomings in services for family members. Reserve component soldiers who had returned to civilian status were referred at higher rates on the PDHRA, which could reflect their concerns about their ongoing health coverage. Lack of confidentiality may deter soldiers with alcohol problems from accessing treatment. In the context of an overburdened system of care, the effectiveness of population mental health screening was difficult to ascertain.

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Longitudinal assessment of mental health problems among active and reserve component soldiers returning from the Iraq war.

A meta-analytic review of prolonged exposure for posttraumatic stress disorder

The purpose of this experiment was to conduct a dismantling study of cognitive processing therapy in which the full protocol was compared with its constituent components—cognitive therapy only (CPT-C) and written accounts (WA)—for the treatment of posttraumatic stress disorder (PTSD) and comorbid symptoms. The intent-to-treat (ITT) sample included 150 adult women with PTSD who were randomized into 1 of the 3 conditions. Each condition consisted of 2 hr of therapy per week for 6 weeks; blind assessments were conducted before treatment, 2 weeks following the last session, and 6 months following treatment. Measures of PTSD and depression were collected weekly to examine the course of recovery during treatment as well as before and after treatment. Secondary measures assessed anxiety, anger, shame, guilt, and dysfunctional cognitions. Independent ratings of adherence and competence were also conducted. Analyses with the ITT sample and with study completers indicate that patients in all 3 treatments improved substantially on PTSD and depression, the primary measures, and improved on other indices of adjustment. However, there were significant group differences in symptom reduction during the course of treatment whereby the CPT-C condition reported greater improvement in PTSD than the WA condition.

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A randomized clinical trial to dismantle components of cognitive processing therapy for posttraumatic stress disorder in female victims of interpersonal violence.

Importance Posttraumatic stress disorder (PTSD) is a disabling psychiatric disorder common among military personnel and veterans. First-line psychotherapies most often recommended for PTSD consist mainly of “trauma-focused” psychotherapies that involve focusing on details of the trauma or associated cognitive and emotional effects. Objective To examine the effectiveness of psychotherapies for PTSD in military and veteran populations. Evidence Review PubMed, PsycINFO, and PILOTS were searched for randomized clinical trials (RCTs) of individual and group psychotherapies for PTSD in military personnel and veterans, published from January 1980 to March 1, 2015. We also searched reference lists of articles, selected reviews, and meta-analyses. Of 891 publications initially identified, 36 were included. Findings Two trauma-focused therapies, cognitive processing therapy (CPT) and prolonged exposure, have been the most frequently studied psychotherapies for military-related PTSD. Five RCTs of CPT (that included 481 patients) and 4 RCTs of prolonged exposure (that included 402 patients) met inclusion criteria. Focusing on intent-to-treat outcomes, within-group posttreatment effect sizes for CPT and prolonged exposure were large (Cohen d range, 0.78-1.10). CPT and prolonged exposure also outperformed waitlist and treatment-as-usual control conditions. Forty-nine percent to 70% of participants receiving CPT and prolonged exposure attained clinically meaningful symptom improvement (defined as a 10- to 12-point decrease in interviewer-assessed or self-reported symptoms). However, mean posttreatment scores for CPT and prolonged exposure remained at or above clinical criteria for PTSD, and approximately two-thirds of patients receiving CPT or prolonged exposure retained their PTSD diagnosis after treatment (range, 60%-72%). CPT and prolonged exposure were marginally superior compared with non–trauma-focused psychotherapy comparison conditions. Conclusions and Relevance In military and veteran populations, trials of the first-line trauma-focused interventions CPT and prolonged exposure have shown clinically meaningful improvements for many patients with PTSD. However, nonresponse rates have been high, many patients continue to have symptoms, and trauma-focused interventions show marginally superior results compared with active control conditions. There is a need for improvement in existing PTSD treatments and for development and testing of novel evidence-based treatments, both trauma-focused and non–trauma-focused.

Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials.

ContextThe prevalence of posttraumatic stress disorder (PTSD) is elevated among women who have served in the military, but no prior study has evaluated treatment for PTSD in this population. Prior research suggests that cognitive behavioral therapy is a particularly effective treatment for PTSD.ObjectiveTo compare prolonged exposure, a type of cognitive behavioral therapy, with present-centered therapy, a supportive intervention, for the treatment of PTSD.Design, Setting, and ParticipantsA randomized controlled trial of female veterans (n=277) and active-duty personnel (n=7) with PTSD recruited from 9 VA medical centers, 2 VA readjustment counseling centers, and 1 military hospital from August 2002 through October 2005.InterventionParticipants were randomly assigned to receive prolonged exposure (n = 141) or present-centered therapy (n = 143), delivered according to standard protocols in 10 weekly 90-minute sessions.Main Outcome MeasuresPosttraumatic stress disorder symptom severity was the primary outcome. Comorbid symptoms, functioning, and quality of life were secondary outcomes. Blinded assessors collected data before and after treatment and at 3- and 6-month follow-up.ResultsWomen who received prolonged exposure experienced greater reduction of PTSD symptoms relative to women who received present-centered therapy (effect size, 0.27; P = .03). The prolonged exposure group was more likely than the present-centered therapy group to no longer meet PTSD diagnostic criteria (41.0% vs 27.8%; odds ratio, 1.80; 95% confidence interval, 1.10-2.96; P = .01) and achieve total remission (15.2% vs 6.9%; odds ratio, 2.43; 95% confidence interval, 1.10-5.37; P = .01). Effects were consistent over time in longitudinal analyses, although in cross-sectional analyses most differences occurred immediately after treatment.ConclusionsProlonged exposure is an effective treatment for PTSD in female veterans and active-duty military personnel. It is feasible to implement prolonged exposure across a range of clinical settings.Trial Registrationclinicaltrials.gov Identifier: NCT00032617

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Cognitive Behavioral Therapy for Posttraumatic Stress Disorder in Women: A Randomized Controlled Trial

BACKGROUND
Although collaborative care is effective for treating depression and other mental disorders in primary care, there have been no randomized trials of collaborative care specifically for patients with Posttraumatic stress disorder (PTSD).

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RESPECT-PTSD: re-engineering systems for the primary care treatment of PTSD, a randomized controlled trial.

Background: This study examined dysfunctional sexual behavior and sexual concerns in women treated for posttraumatic stress disorder (PTSD). There were three objectives: to characterize the relationship between symptoms of PTSD and sexual outcomes, to examine the effect of treatment on sexual outcomes, and to examine the relationship between change in PTSD and change in sexual outcomes. Methods: Female veterans and active duty personnel with PTSD (n = 242), 93% of whom had experienced sexual trauma, were randomly assigned to receive 10 weekly sessions of either Prolonged Exposure or Present-Centered Therapy. PTSD and sexual outcomes were assessed before and after treatment and then 3 and 6 months later. Results: At baseline, the reexperiencing, numbing, and hyperarousal symptom clusters were related to one or both sexual outcomes. Although prior analyses had shown that Prolonged Exposure resulted in better PTSD outcomes, there were no differences between treatments for either dysfunctional sexual...

Veronica Thurston

Papers

Cognitive Behavioral Therapy for Posttraumatic Stress Disorder in Women: A Randomized Controlled Trial

RESPECT-PTSD: re-engineering systems for the primary care treatment of PTSD, a randomized controlled trial.

Sexual function outcomes in women treated for posttraumatic stress disorder.

Cognitive Behavioral Therapy for Posttraumatic Stress Disorder in Women