Clinician-Administered Posttraumatic Stress Disorder Scale For DSM-5 Research Articles

Supplemental Material for Reliable and Clinically Significant Change in the Clinician-Administered PTSD Scale for DSM-5 and PTSD Checklist for DSM-5 Among Male Veterans

Supplemental Material for Reliable and Clinically Significant Change in the Clinician-Administered PTSD Scale for DSM-5 and PTSD Checklist for DSM-5 Among Male Veterans

Exploring the relationship between the gut microbiome and mental health outcomes in a posttraumatic stress disorder cohort relative to trauma-exposed controls

Posttraumatic stress disorder (PTSD) imposes a significant burden on patients and communities. Although the microbiome-gut-brain axis has been proposed as a mediator or moderator of PTSD risk and persistence of symptoms, clinical data directly delineating the gut microbiome's relationship to PTSD are sparse. This study investigated associations between the gut microbiome and mental health outcomes in participants with PTSD (n = 79) and trauma-exposed controls (TECs) (n = 58). Diagnoses of PTSD, major depressive disorder (MDD), and childhood trauma were made using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), MINI International Neuropsychiatric Interview (MINI), and Childhood Trauma Questionnaire (CTQ), respectively. Microbial communities from stool samples were profiled using 16S ribosomal RNA gene V4 amplicon sequencing and tested for associations with PTSD-related variables of interest. Random forest models identified a consortium of four genera, i.e., a combination of Mitsuokella, Odoribacter, Catenibacterium, and Olsenella, previously associated with periodontal disease, that could distinguish PTSD status with 66.4% accuracy. The relative abundance of this consortium was higher in the PTSD group and correlated positively with CAPS-5 and CTQ scores. MDD diagnosis was also associated with increased relative abundance of the Bacteroidetes phylum. Current use of psychotropics significantly impacted community composition and the relative abundances of several taxa. Early life trauma may prime the microbiome for changes in composition that facilitate a pro-inflammatory cascade and increase the risk of development of PTSD. Future studies should rigorously stratify participants into healthy controls, TECs, and PTSD (stratified by psychotropic drug use) to explore the role of the oral-gut-microbiome-brain axis in trauma-related disorders.

Global prevalence and associated risk factors of posttraumatic stress disorder during COVID-19 pandemic: A meta-analysis

BackgroundThe COVID-19 pandemic has negatively impacted the psychological well-being of individuals and society. Previous studies conducted on coronavirus outbreaks including Severe Acute Respiratory Syndrome and Middle East Respiratory Syndrome pandemic found that posttraumatic stress disorder (PTSD), depression, and anxiety were the most common mental health problems and long-term consequences of these outbreaks. Currently, comprehensive and integrated information on the global prevalence of PTSD due to the COVID-19 pandemic is lacking. ObjectiveIn the present meta-analysis, we examined the global prevalence and associated risk factors of PTSD in patients/survivors of COVID-19, health professionals, and the population at large. DesignMeta-analysis. Data SourceCochrane, CINAHL, Embase, MEDLINE, PubMed, Scopus, Web of Science, and manual search up to June 2021. MethodsWe included studies evaluating the prevalence of PTSD during the COVID-19 pandemic in either patients/survivors, health professionals, and the population at large. The data were analyzed using logit transformation with the random-effects model. Risk of bias assessment was conducted using Hoy and colleagues. ResultsA total of 63 studies (n = 124,952) from 24 different countries were involved. The overall pooled estimate of PTSD prevalence was 17.52% (95% CI 13.89 to 21.86), with no evidence of publication bias (t=-0.22, p-value=0.83). This study found a high prevalence of PTSD among patients with COVID-19 (15.45%; 95% CI 10.59 to 21.99), health professionals (17.23%; 95% CI 11.78 to 24.50), and the population at large (17.34%; 95% CI 12.21 to 24.03). Subgroup analyses showed that those working in COVID-19 units (30.98%; 95% CI, 16.85 to 49.86), nurses (28.22%; 95% CI, 15.83 to 45.10), those living in European countries (25.05%; 95% CI 19.14 to 32.06), and studies that used Clinician-Administered PTSD Scale for DSM-5 (30.18%, 95% CI 25.78 to 34.98) demonstrated to have the highest PTSD prevalence compared to other subgroups. Meta-regression analyses revealed that the elderly (above age 65) had lower PTSD prevalence (-1.75, 95% CI -3.16 to -0.34) than the adult population. Conclusion and ImplicationsSubstantial PTSD prevalence was found in patients with COVID-19, health professionals, and the population at large. Moderator analysis revealed that age, unit of work, health profession, continent, and assessment tools as significant moderators. Mental health services are needed for everyone, especially adults under the age of 65, those who work in COVID-19 units, nurses, and people in the European continent. RegistrationThe study protocol was registered with the International database of prospective registered systematic reviews (PROSPERO): CRD42020218762.Tweetable abstract: The pooled PTSD prevalence during COVID-19 pandemic for patients with COVID-19, health professionals, and the population at large was 17.52%.

Hippocampal Resting-State Functional Connectivity Forecasts Individual Posttraumatic Stress Disorder Symptoms: A Data-Driven Approach

BackgroundPosttraumatic stress disorder (PTSD) is a debilitating disorder, and there is no current accurate prediction of who develops it after trauma. Neurobiologically, individuals with chronic PTSD exhibit aberrant resting-state functional connectivity (rsFC) between the hippocampus and other brain regions (e.g., amygdala, prefrontal cortex, posterior cingulate), and these aberrations correlate with severity of illness. Previous small-scale research (n < 25) has also shown that hippocampal rsFC measured acutely after trauma is predictive of future severity using a region-of-interest–based approach. While this is a promising biomarker, to date, no study has used a data-driven approach to test whole-brain hippocampal FC patterns in forecasting the development of PTSD symptoms. MethodsA total of 98 adults at risk of PTSD were recruited from the emergency department after traumatic injury and completed resting-state functional magnetic resonance imaging (8 min) within 1 month; 6 months later, they completed the Clinician-Administered PTSD Scale for DSM-5 for assessment of PTSD symptom severity. Whole-brain rsFC values with bilateral hippocampi were extracted (using CONN) and used in a machine learning kernel ridge regression analysis (PRoNTo); a k-folds (k = 10) and 70/30 testing versus training split approach were used for cross-validation (1000 iterations to bootstrap confidence intervals for significance values). ResultsAcute hippocampal rsFC significantly predicted Clinician-Administered PTSD Scale for DSM-5 scores at 6 months (r = 0.30, p = .006; mean squared error = 120.58, p = .006; R2 = 0.09, p = .025). In post hoc analyses, hippocampal rsFC remained significant after controlling for demographics, PTSD symptoms at baseline, and depression, anxiety, and stress severity at 6 months (B = 0.59, SE = 0.20, p = .003). ConclusionsFindings suggest that functional connectivity of the hippocampus across the brain acutely after traumatic injury is associated with prospective PTSD symptom severity.

Longitudinal change in self-reported peritraumatic dissociation during and after a course of posttraumatic stress disorder treatment: Contributions of symptom severity and time.

Objective: Peritraumatic dissociation, a dissociative reaction that occurs at the time of a traumatic event, has been established as a strong risk factor for posttraumatic stress disorder (PTSD). However, self-reported peritraumatic dissociation is typically assessed months or years after trauma exposure and may be influenced by current distress levels and other factors. Method: We examined the temporal stability of scores on the Peritraumatic Dissociative Experiences Questionnaire (PDEQ) among 126 treatment-seeking adults with PTSD during and after trauma-focused treatment. Participants reported dissociation during the same index event at baseline and 6, 12, 24, 36, and 60 weeks after the first treatment session. Results: There were substantial changes in PDEQ total scores over time, with > 40% of participants experiencing reliable change from baseline at least once during the study. Multilevel modeling revealed an overall decrease in PDEQ scores over time; scores on the Clinician-Administered PTSD Scale for DSM-5, Beck Depression Inventory-II, and PTSD Checklist for DSM-5 were each significantly associated with PDEQ scores. Conclusions: Our findings suggest the PDEQ does not provide temporally stable assessment of peritraumatic dissociation. Accordingly, it is crucial to control for current PTSD symptom levels when examining the degree to which peritraumatic dissociation confers risk for future symptom severity. Without such an accounting, our understanding of the relationship between PTSD and peritraumatic dissociation may be incorrect. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

A-139 Relationship between Obstructive Sleep Apnea and Neurocognitive Performance in a Veteran Population with Post-Traumatic Stress Disorder Symptomatology

Abstract Objective Obstructive Sleep Apnea (OSA) is associated with neuropsychological challenges, including attentional difficulties (Kim et al., 2017), and commonly comorbid with Posttraumatic Stress Disorder (PTSD) in veteran samples (Yesavage et al., 2014). We further explore the relationship between OSA and cognition in veterans with PTSD symptomatology. Method 58 veterans (6 females; mean age = 57.53 years, SD = 13.63) with OSA were screened as part of a larger outpatient study at Palo Alto VA Hospital, completing neuropsychological testing and Clinician Administered PTSD Scale for DSM-5 (CAPS-5) interview. Mean Apnea Hypopnea Index (AHI) was 23.95 (SD = 15.97). Positive Airway Pressure (PAP) therapy had not started at the time of screening. Domain-specific composite scores were created using z-score transformation of individual test scores and hierarchical regression used. Results Initial regression model was significant (F(1,57) = 4.99, p = 0.03, R2 = 0.081) with AHI significantly predicting executive function (EF; β = −0.28, p = 0.03). Attention was then entered into the model (F(2,56) = 22.31, p &amp;lt; 0.01, R2 = 0.44) and significantly predicted EF (β = 0.63, p &amp;lt; 0.01), but AHI was no longer significant. Lastly, CAPS-5 score (last month) was entered as a covariate to control for PTSD symptom severity (F(3,55) = 14.94, p &amp;lt; 0.01, R2 = 0.45); however, attention remained the only significant predictor of EF (β = 0.63, p &amp;lt; 0.01). Conclusions Findings suggest that EF concerns related to OSA may be driven by decreased attention performance, suggesting areas to highlight when formulating recommendations and treatment planning. Further implications and directions to be discussed. Funding Acknowledgements Supported by the Research Service of the Department of Veterans Affairs (Grant Number 1I01RX001799-01A2), VAPAHCS, and Sierra-Pacific MIRECC.

After a disaster: Validation of PTSD checklist for DSM-5 and the four- and eight-item abbreviated versions in mental health service users

Posttraumatic stress disorder (PTSD) is a common and disabling condition developing in one of four survivors after an earthquake. Brief and self-reported validated measures for assessing PTSD symptom severity are necessary to improve care access and assess disorder progress and treatment response. Therefore, we evaluated the psychometric properties of the PTSD-Checklist for the DSM-5 (PCL-5) of 20-, 8- and 4-item in patients that sought specialized mental health services after a catastrophic earthquake that stroke Mexico on September 19th, 2017. The internal consistency of 20-, 8- and 4-item PCL-5 was adequate (≥.7). Using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) as a reference, signal detection analyses revealed a PCL-5 score of 27 as optimal (sensitivity = .96, specificity = .73) for identifying probable PTSD cases. The shortened versions highly correlated with the full PCL-5 and had comparable diagnostic utility. Our results indicate that the 20-item PCL-5 and the abridged versions can effectively identify possible PTSD cases. The 8-item version has better psychometric properties and more consistent diagnostic utility across time and civil populations. These measures must be evaluated in independent samples to corroborate their utility in different populations and regarding diverse traumatic events.

The impact of childhood maltreatment on the severity of childhood-related posttraumatic stress disorder in adults

BackgroundChildhood maltreatment is relatively common and is related to a range of negative consequences, such as Posttraumatic Stress Disorder (PTSD). There are indications that various maltreatment types are related to PTSD severity, although not all types, such as emotional abuse, meet the PTSD Criterion-A. ObjectiveThe aim of the present study was to examine the relationship between 5 types of childhood maltreatment (i.e., sexual, physical, and emotional abuse, and physical and emotional neglect) and the severity of adult PTSD and PTSD symptoms. Participants and settingAdult participants (N = 147) with Childhood-related PTSD (Ch-PTSD) recruited from clinical sites completed the Childhood Trauma Questionnaire-short form (CTQ-sf) and 2 PTSD measures: The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Checklist for DSM-5 (PCL-5). MethodsChildhood maltreatment predictors and 2 covariates, age and gender, were analysed in multivariate multilevel models as participants were nested within sites. A model selection procedure, in which all combinations of predictors were examined, was used to select a final set of predictors. ResultsThe results indicated that emotional abuse was the only trauma type that was significantly related to severity of PTSD and to the severity of specific PTSD symptom clusters (r between 0.130 and 0.338). The final models explained between 6.5% and 16.7% of the variance in PTSD severity. ConclusionsThe findings suggest that emotional abuse plays a more important role in Ch-PTSD than hitherto assumed, and that treatment should not neglect processing of childhood emotional abuse.

Scaling Up: Multisite Open-Label Clinical Trials of MDMA-Assisted Therapy for Severe Posttraumatic Stress Disorder

Background: Posttraumatic stress disorder (PTSD) is a debilitating mental health condition associated with serious adverse health outcomes and functional impairment. Previous MDMA–assisted therapy (MDMA-AT) studies have shown promising results in single site studies. Two open-label studies tested this modality in multisite clinical trials to assess the feasibility of scaling this manualized therapy across 14 North American sites. Method: Cotherapist dyads were trained in the manualized MDMA-AT protocol and administered three experimental sessions 3 to 5 weeks apart among participants with severe PTSD. Cotherapist dyads were provided clinical supervision and evaluated for protocol adherence by centralized raters. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) assessed change in symptoms severity. Results: Adherence rating scores were high across cotherapist dyads ( M = 95.08%, SD = 3.70%) and sites ( M = 95.23%, SD = 2.20%). CAPS-5 scores decreased following 3 MDMA-AT sessions at 18 weeks post baseline (Δ M = −29.99, Δ SD = 13.45, p &lt; .0001, n = 37, Cohen’s d = 2.2, confidence interval [1.97, 2.47]). MDMA was well tolerated. Conclusions: These findings corroborate previous results that MDMA-AT can achieve significant improvements in PTSD symptom severity and demonstrate scalability of manualized therapy across clinic sites in the United States and Canada.

Randomized, Placebo-Controlled Trial of the Angiotensin Receptor Antagonist Losartan for Posttraumatic Stress Disorder

BackgroundEvidence-based pharmacological treatments for posttraumatic stress disorder (PTSD) are few and of limited efficacy. Previous work suggests that angiotensin type 1 receptor inhibition facilitates fear inhibition and extinction, important for recovery from PTSD. This study tests the efficacy of the angiotensin type 1 receptor antagonist losartan, an antihypertensive drug, repurposed for the treatment of PTSD. MethodsA randomized controlled trial was conducted for 10 weeks in 149 men and women meeting DSM-5 PTSD criteria. Losartan (vs. placebo) was flexibly titrated from 25 to 100 mg/day by week 6 and held at highest tolerated dose until week 10. Primary outcome was the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) change score at 10 weeks from baseline. A key secondary outcome was change in CAPS-5 associated with a single nucleotide polymorphism of the ACE gene. Additional secondary outcomes included changes in the PTSD Checklist for DSM-5 and the Patient Health Questionnaire-9, and proportion of responders with a Clinical Global Impressions–Improvement scale of “much improved” or “very much improved.” ResultsBoth groups had robust improvement in PTSD symptoms, but there was no significant difference on the primary end point, CAPS-5 measured as week 10 change from baseline, between losartan and placebo (mean change difference, 0.9, 95% confidence interval, −3.2 to 5.0). There was no significant difference in the proportion of Clinical Global Impressions–Improvement scale responders for losartan (58.6%) versus placebo (57.9%), no significant differences in changes in PTSD Checklist for DSM-5 or Patient Health Questionnaire-9, and no association between ACE genotype and CAPS-5 improvement on losartan. ConclusionsAt these doses and durations, there was no significant benefit of losartan compared with placebo for the treatment of PTSD. We discuss implications for failure to determine the benefit of a repurposed drug with strong a priori expectations of success based on preclinical and epidemiological data.

The Efficacy of MDMA (3,4-Methylenedioxymethamphetamine) for Post-traumatic Stress Disorder in Humans: A Systematic Review and Meta-Analysis.

Background: 3,4-methylenedioxymethamphetamine (MDMA), known recreationally as “Molly” or “Ecstasy”, is a triple monoamine reuptake inhibitor. MDMA specifically acts as a weak 5-HT1 and 5-HT2 receptor agonist, targeting 5-HT2A, 5-HT2B, and 5-HT2C receptors. Its potential use for therapeutic purposes with these pharmacological profiles remains a controversial subject. Studies have shown the potential benefits in clinical trials for post-traumatic stress disorder (PTSD). A larger amount of data has been provided for the push in support of MDMA-assisted psychotherapy in these patients. Objective: The aim of this article is to compute a meta-analysis and conduct a systematic review of the effects of MDMA on PTSD, discussing the potential benefits and adverse events relative to dosing and stability of treatment.Methods: Articles were collected and analyzed for systematic review: 16 articles were included in the systematic review that met the criteria for the use of MDMA in the treatment of PTSD as well as assessing the safety and efficacy of the drug in human participants. Ten studies were used for the meta-analysis, with a cumulative sample size of 168 patients. The significance of the findings on dosing and efficacy of MDMA in healthy human participants was quantified based on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and PTSD symptom scores.Results: The disorders for which MDMA demonstrated a net positive or net negative effect on symptoms are presented separately. Adverse events in patients across all disease classes are presented. The therapeutic index for patients who demonstrated a benefit is also presented. An odds ratio for beneficial and adverse events is used to determine treatment-resistant patients who may benefit from clinical trials of MDMA.Discussion: Findings show promising evidence for the potential therapeutic use of MDMA alongside psychotherapy in the treatment of PTSD. The pharmacological profile of MDMA may provide direction for future drug developments to treat patients with treatment-resistant psychiatric disorders.

MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study

Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants (n = 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions. PTSD symptoms, measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5, the primary endpoint), and functional impairment, measured with the Sheehan Disability Scale (SDS, the secondary endpoint) were assessed at baseline and at 2 months after the last experimental session. Adverse events and suicidality were tracked throughout the study. MDMA was found to induce significant and robust attenuation in CAPS-5 score compared with placebo (P < 0.0001, d = 0.91) and to significantly decrease the SDS total score (P = 0.0116, d = 0.43). The mean change in CAPS-5 scores in participants completing treatment was −24.4 (s.d. 11.6) in the MDMA group and −13.9 (s.d. 11.5) in the placebo group. MDMA did not induce adverse events of abuse potential, suicidality or QT prolongation. These data indicate that, compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities. We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation.

Development and Validation of a Semi-Structured Clinical Interview for Nightmare Disorder

Objectives Nightmare disorder is highly prevalent in clinical settings and is highly comorbid with posttraumatic stress disorder (PTSD). In the current study, we aimed to develop and validate a semi-structured interview based on the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders-fifth edition for diagnosing nightmare disorder. Methods We developed a Semi-Structured Clinical Interview for Nightmare Disorder (SCIN) in five steps: we interviewed 100 females (mean age, 24.6±5.88 years) using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5); Structured Clinical Interview for DSM-IV Axis 1 Disorders, Research Version (SCID-I); and self-report questionnaires for nightmares (Disturbing Dream and Nightmare Severity Index, DDNSI), depression, state anxiety, trait anxiety, suicidal ideation, and insomnia. Two independent raters assessed the responses of the interviewees. The interrater reliability for the SCIN was calculated. Pearson’s correlation coefficient was used to assess convergent validity between SCIN and the DDNSI. Chi-square analyses were conducted to compare prevalence of PTSD based on nightmare disorder diagnosis. Results Among the participants, 42% were diagnosed with nightmare disorder, 15% had subthreshold nightmare disorder, and 43% did not have nightmare disorder. Interrater reliability was moderate (Kappa=0.707, p<0.001). The semi-structured clinical interview showed good convergent validity with the DDNSI (r=0.639, p<0.001). Additionally, individuals who were identified as having nightmare disorder had higher levels of depression, state anxiety, trait anxiety, suicidal ideation, and insomnia (p<0.001). Based on the PTSD diagnosis using CAPS-5, the nightmare group had a higher proportion of PTSD diagnoses than the no-nightmare group (26.2% vs. 8.6%, respectively; χ2=38.41, p<0.001). Conclusions The semi-structured clinical interview for nightmare disorder appears to have good reliability and validity and can be used in clinical settings. Keywords: Sleep, Parasomnias, Sleep wake disorders, Psychological interview, Nightmares

Electroconvulsive therapy with a memory reactivation intervention for post-traumatic stress disorder: A randomized controlled trial

BackgroundPost-traumatic Stress Disorder (PTSD) often does not respond to available treatments. Memories are vulnerable to disruption during reconsolidation, and electroconvulsive therapy (ECT) has amnestic effects Objective/hypothesisTo test the use of ECT to disrupt the reconsolidation of traumatic memories as a potential treatment for PTSD MethodsParticipants were adults from the civilian population and were referred for ECT treatment for severe depression with comorbid PTSD symptoms. Twenty-eight participants were randomly assigned to reactivation of a traumatic or non-traumatic memory using audio script driven imagery prior to each ECT treatment. Primary outcomes were change in scores on the Modified PTSD Symptom Scale - Self Report (MPSS-SR) and the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Secondary outcomes included a comparison of the change in heart rate while listening to the script ResultsTwenty-five female patients who completed a post-ECT assessment were included in the analysis. No significant group differences were found in the MPSS-SR or CAPS-5 scores from pre-ECT to post-ECT or 3-month follow-ups. However, both groups improved at post-ECT and 3-month follow up. Partial eta squared estimates of effect size showed large effect sizes for all outcomes (η2 > 0.13). Changes in heart rate were not significantly different between groups or over time ConclusionsECT paired with pre-treatment traumatic memory reactivation was not more effective for treating PTSD symptoms than ECT with non-traumatic memory reactivation. While our primary hypothesis was not supported, our data provides further support for the efficacy of ECT for improving symptoms of PTSD with comorbid depression.ClinicalTrials.gov.https://clinicaltrials.gov/ct2/show/NCT04027452. IdentifierNCT04027452.

A Pilot Randomized Controlled Trial of Transcendental Meditation as Treatment for Posttraumatic Stress Disorder in Veterans.

Preliminary studies have demonstrated the efficacy of Transcendental Meditation (TM) for treating posttraumatic stress disorder (PTSD). The present study extended previous research with a pilot trial of TM as a treatment for PTSD via a single-blinded, randomized controlled design. veterans with PTSD (N = 40) were assigned to a TM intervention or treatment-as-usual (TAU) control group. Participants in the TM group engaged in 16 sessions over 12 weeks, primarily in a 60-min group format. Change in PTSD symptoms, measured via the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) was the primary outcome. Secondary outcomes included self-reported PTSD symptoms, depression, anxiety, sleep difficulties, anger, and quality of life (QoL). Assessments were conducted at baseline and 3-month follow-up. Mean CAPS-5 score decreases were significantly larger for participants in the TM group (M = -11.28, 95% CI [-17.35, -5.20]), compared to the TAU group (M = -1.62, 95% CI [-6.77, 3.52]), p = .012, d = -0.84. At posttest, 50.0% of veterans in the TM group no longer met PTSD diagnostic criteria as compared to 10.0% in the TAU group, p = .007. Adjusted mean changes on self-report measures of PTSD symptoms, depression, anxiety, and sleep difficulties indicated significant reductions in the TM group compared to TAU, ds = .80-1.16. There were no significant group differences regarding anger or QoL. These findings demonstrate the efficacy of TM as a treatment for veterans with PTSD and for comorbid symptoms. Combined with other research, they suggest that TM may be a tolerable, non-trauma-focused PTSD treatment.

Trauma-Sensitive Yoga for Post-Traumatic Stress Disorder in Women Veterans who Experienced Military Sexual Trauma: Interim Results from a Randomized Controlled Trial.

Objective: To conduct an interim analysis of data collected from an ongoing multisite randomized clinical trial (RCT) assessing the effectiveness of Trauma Center Trauma-Sensitive Yoga (TCTSY) for post-traumatic stress disorder (PTSD) among women veterans with PTSD related to military sexual trauma (MST). The purpose of the interim analysis was to assess outcomes from the primary site, which is geographically, demographically, culturally, and procedurally distinct from the second site. Design: RCT was conducted within a Veterans Administration Health Care System. Data collection included preintervention through 3 months postintervention. Participants: Enrollment for the main site was 152 women. The sample size for the intent-to-treat analysis was 104. The majority were African American (91.3%) with a mean age of 48.46 years. Intervention: The TCTSY intervention (n = 58) was conducted by TCTSY-certified yoga facilitators and consisted of 10 weekly 60-min group sessions. The control intervention, cognitive processing therapy (CPT; n = 46), consisted of 12 90-min weekly group sessions conducted per Veterans Administration protocol by clinicians in the PTSD Clinic. Outcome measures: The Clinician Administered PTSD Scale for DSM-5 (CAPS-5) was used to assess current PTSD diagnosis and symptom severity, including overall PTSD and four symptom clusters. The PTSD checklist for DSM-5 (PCL-5) was used to obtain self-report of PTSD symptom severity, including total score and four symptom clusters. Results: The findings reported here are interim results from one clinical site. For both the CAPS-5 and PCL-5, total scores and all four criterion scores decreased significantly (p < 0.01) over time in all five multilevel linear models within both TCTSY and CPT groups, without significant differences between groups. There were clinically meaningful improvements seen for both TCTSY and CPT with 51.1%-64.3% of TCTSY subjects and 43.5%-73.7% of CPT decreasing their CAPS-5 scores by 10 points or more. Effect sizes for total symptom severity were large for TCTSY (Cohen's d = 1.10-1.18) and CPT (Cohen's d = 0.90-1.40). Intervention completion was higher in TCTSY (60.3%) than in CPT (34.8%). Symptom improvement occurred earlier for TCTSY (midintervention) than for CPT (2 weeks postintervention). Safety: There were no unanticipated adverse events in this study. Conclusion: The results of this study demonstrate that TCTSY may be an effective treatment for PTSD that yields symptom improvement more quickly, has higher retention than CPT, and has a sustained effect. TCTSY may be an effective alternative to trauma-focused therapy for women veterans with PTSD related to MST. The study is registered in ClinicalTrials.gov (CTR no.: NCT02640690).

Efficacy of Vortioxetine Monotherapy for Posttraumatic Stress Disorder: A Randomized, Placebo-Controlled Trial.

There are few efficacious pharmacological treatments for posttraumatic stress disorder (PTSD) and many patients fail to benefit from existing treatments. Vortioxetine, a recently developed antidepressant, acts as a serotonin modulator through inhibition of the serotonin transporter and actions at multiple types of serotonin receptors. Its unique pharmacodynamic profile suggests it may have efficacy for the treatment of PTSD. We conducted a 12-week placebo-controlled, randomized clinical trial of vortioxetine (flexibly dosed from 10 to 20 mg/d) versus placebo in adults with PTSD. The primary outcome was change from baseline in the past-month version of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), analyzed using a mixed-model repeated-measures analysis of variance. Forty-one patients were randomized, and 32 (78%) completed the 12 weeks of treatment. The mean reduction in CAPS-5 scores at week 12 did not significantly differ between the 2 arms; the effect size for the difference in changes between vortioxetine and placebo on CAPS-5 total scores at week 12 was Cohen d = 0.29. However, at week 8, the drug-placebo difference was d = 0.78, which met the multivariate criteria for statistical significance, P = 0.014. In this study of 41 patients, vortioxetine did not demonstrate superiority over placebo for adults with PTSD. Future PTSD trials may benefit from stratifying the randomization based on number of years since the index traumatic event and a history of failure to respond to treatment.

Pain interference and quality of life in combat veterans: Examining the roles of posttraumatic stress disorder, traumatic brain injury, and sleep quality.

The goal of this study was to examine the associations among posttraumatic stress disorder (PTSD), traumatic brain injury (TBI), sleep quality, pain interference, and quality of life in combat veterans. Veterans (N = 289, 86.51% male) completed the Mid-Atlantic MIRECC Assessment of Traumatic Brain Injury, the Clinician-Administered PTSD Scale for DSM-5, and measures of sleep quality, pain interference, and quality of life. Hierarchical linear regressions evaluated associations between PTSD severity, deployment TBI severity, sleep quality, and the outcomes of pain interference and quality of life after adjusting for demographic variables and the number of nondeployment TBIs. PTSD severity, B = 0.15, SE B = 0.04, deployment TBI severity, B = 3.98, SE B = 1.01, and sleep quality, B = 0.74, SE B = 0.13, were significantly associated with pain interference, p < .001. PTSD severity, B = -0.57, SE B = 0.07, and pain interference, B = -0.45, SE B = 0.11, were significantly, independently associated with quality of life, p < .001. However, pain interference, B = -0.24, SE B = 0.11, was no longer significantly associated with quality of life when sleep quality, B = -1.56, SE B = 0.25, was included in the model. There was no significant association between deployment TBI severity and quality of life. Interactions among the studied variables were not significant for either of the outcome variables. PTSD symptom severity, deployment TBI history, and sleep quality may be important to consider in treatment planning for veterans experiencing pain-related functional interference. For veterans with numerous conditions comorbid with pain, treatment plans may include interventions targeting sleep and PTSD to maximize quality of life improvements. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

A Randomized Controlled Trial of Repeated Ketamine Administration for Chronic Posttraumatic Stress Disorder.

Posttraumatic stress disorder (PTSD) is a chronic and disabling disorder, for which available pharmacotherapies have limited efficacy. The authors' previous proof-of-concept randomized controlled trial of single-dose intravenous ketamine infusion in individuals with PTSD showed significant and rapid PTSD symptom reduction 24 hours postinfusion. The present study is the first randomized controlled trial to test the efficacy and safety of repeated intravenous ketamine infusions for the treatment of chronic PTSD. Individuals with chronic PTSD (N=30) were randomly assigned (1:1) to receive six infusions of ketamine (0.5 mg/kg) or midazolam (0.045 mg/kg) (psychoactive placebo control) over 2 consecutive weeks. Clinician-rated and self-report assessments were administered 24 hours after the first infusion and at weekly visits. The primary outcome measure was change in PTSD symptom severity, as assessed with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), from baseline to 2 weeks (after completion of all infusions). Secondary outcome measures included the Impact of Event Scale-Revised, the Montgomery-Åsberg Depression Rating Scale (MADRS), and side effect measures. The ketamine group showed a significantly greater improvement in CAPS-5 and MADRS total scores than the midazolam group from baseline to week 2. At week 2, the mean CAPS-5 total score was 11.88 points (SE=3.96) lower in the ketamine group than in the midazolam group (d=1.13, 95% CI=0.36, 1.91). Sixty-seven percent of participants in the ketamine group were treatment responders, compared with 20% in the midazolam group. Among ketamine responders, the median time to loss of response was 27.5 days following the 2-week course of infusions. Ketamine infusions were well tolerated overall, without serious adverse events. This randomized controlled trial provides the first evidence of efficacy of repeated ketamine infusions in reducing symptom severity in individuals with chronic PTSD. Further studies are warranted to understand ketamine's full potential as a treatment for chronic PTSD.

The reconsolidation using rewind study (RETURN): trial protocol

ABSTRACT Background: An increasing body of research highlights reconsolidation-based therapies as emerging treatments for post-traumatic stress disorder (PTSD). The Rewind Technique is a non-pharmacological reconsolidation-based therapy with promising early results, which now requires evaluation through an RCT. Objectives: This is a preliminary efficacy RCT to determine if the Rewind Technique is likely to be a good candidate to test against usual care in a future pragmatic efficacy RCT. Methods: 40 participants will be randomised to receive either the Rewind Technique immediately, or after an 8 week wait. The primary outcome will be PTSD symptom severity as measured by the Clinician-Administered PTSD Scale for DSM5 (CAPS-5) at 8 and 16 weeks post-randomisation. Secondary outcome measures include the PTSD Checklist (PCL-5), International Trauma Questionnaire (ITQ), Patient Health Questionnaire (PHQ-9), the General Anxiety Disorder-7 (GAD-7), Insomnia Severity Index, the Euro-Qol-5D (EQ5D-5 L), the prominence of re-experiencing specific symptoms (CAPS-5) and an intervention acceptability questionnaire to measure tolerability of the intervention. Conclusions: This study will be the first RCT to assess the Rewind Technique. Using a cross-over methodology we hope to rigorously assess the efficacy and tolerability of Rewind using pragmatic inclusion criteria. Potential challenges include participant recruitment and retention. Trial registration: ISRCTN91345822