A proof-of-concept randomized crossover clinical trial of a first-in-class vasopressin 1a receptor antagonist for PTSD: Design, methods, and recruitment.

Background: Almost eight million Americans suffer from Posttraumatic Stress Disorder (PTSD). Current PTSD drug therapies rely on repurposed antidepressants and anxiolytics, which produce undesirable side effects and have recognized compliance issues. Vasopressin represents a promising and novel target for pharmacological intervention. Logistical issues implementing a clinical trial for a novel PTSD pharmaceutical are relatively uncharted territory as trials concerning a new agent have not been published in the past several decades. All published trials have repurposed FDA-approved psychoactive medications with known risk profiles. Our recruitment challenges are discussed in this context. Methods: An 18-week proof-of-concept randomized crossover clinical trial of a first-in-class vasopressin 1a receptor antagonist (SRX246) for PTSD was conducted. All participants received SRX246 for 8 weeks, the placebo for 8 weeks, and the drug vs. placebo arms were compared. Participants were assessed every 2 weeks for PTSD symptoms as well as other medication effects. Results were expected to provide an initial demonstration of safety and tolerability in this clinical population and potentially clinical efficacy in SRX246-treated patients measured by Clinician Administered PTSD Scale (CAPS) score changes, clinical impression, and other indices compared to placebo. The primary hypothesis was that SRX246 would result in a clinically meaningful 10-point reduction in mean CAPS score compared to placebo. Discussion: This study is the first to investigate an oral vasopressin 1a receptor antagonist for PTSD. As a wave of PTSD clinical trials with new pharmaceutical compounds are beginning now, lessons learned from our recruitment challenges may be invaluable to these endeavors.

Training Staff Across the Veterans Affairs Health Care System to Use Mobile Mental Health Apps: A National Quality Improvement Project.

BACKGROUND: The National Center for PTSD, within the Department of Veterans Affairs (VA), has developed a suite of free, publicly available, evidence-informed apps that can reach an increasing number of veterans and bridge gaps in care by providing resources to those who are not engaged in mental health treatment. To expand the reach of these apps, staff across VA service lines learned about these apps, their features and limitations, and how to introduce them to veterans. OBJECTIVE: This study aimed to develop, disseminate, and evaluate a training for multidisciplinary staff as part of a national quality improvement project to increase the reach of mobile mental health apps as a resource for veterans. METHODS: Sites from all of VA's 18 geographic regions enrolled in this project. At each site, a minimum of 25 VA staff members who had direct contact with veterans, including staff from the mental health service line and all other service lines, were recruited to participate. Training included a 3-hour multidisciplinary core module, and a 1-hour clinical integration module designed specifically for mental health clinicians. Owing to the COVID-19 pandemic, the trainings were adapted to a live, web-based format. Pre- and posttraining surveys assessed program reach (ie, participants enrolled per site), satisfaction, and effectiveness of the training as measured by changes in knowledge, basic skills, and behavioral intentions to use apps with veterans. RESULTS: A total of 1110 participants representing 34 disciplines at 19 VA sites completed the training. Overall, 67% (743/1109) of participants were mental health staff members. Sites averaged 58.4 participants (SD 36.49, median [IQR] 51). Most (961/1024, 93.85%) participants were satisfied with the training and reported that they (941/1018, 92.44%) would recommend it to others. App knowledge scores significantly increased from pretraining (mean 80.8% correct, SD 15.77%) to posttraining (mean 91.1% correct, SD 9.57%; P<.001). At posttraining, participants also reported greater confidence in their ability to show veterans how to download (z=-13.86; P<.001) and use VA mental health apps (z=-15.13; P<.001). There was near universal endorsement by staff for their intentions to recommend apps to veterans as well as their ability to think of at least one specific veteran to whom they could recommend an app. Staff also reported a strong motivation to encourage other VA staff to share apps with veterans. CONCLUSIONS: The training far exceeded the initial goals for staff recruitment and training for all three metrics. Overall, 33% (366/1109) of participants came from service lines outside of mental health, indicating the feasibility of introducing these mental health resources during medical appointments and in other contexts.

Military acculturation and readjustment to the civilian context.

OBJECTIVE: Attitudes and beliefs related to immersion in military culture can affect postseparation transition to the civilian setting. The etiology and complexity of these reactions are often overlooked by mental health providers, which can result in negative consequences for treatment. This qualitative study examined veterans' perceptions of military culture and the impact of military service on veterans' values, beliefs, and behaviors. The goal of this research was to identify aspects of military culture that are important for health care providers to consider as they care for veterans and to inform culturally sensitive mental health care for veterans. METHOD: Fifty-two military veterans completed a self-report survey and participated in semistructured focus groups. RESULTS: Participants reported diverse military experiences, and many endorsed a high level of continuing identification with aspects of military culture. Seven broad themes related to military culture emerged from qualitative analyses: (a) military values, beliefs, and behaviors; (b) relationships; (c) occupational habits and practices; (d) acquired skills; (e) communication; (f) affiliation; and (g) psychological health and well-being. CONCLUSION: This thematic analysis elucidated strategies to improve mental health services for veterans, using a nuanced model that encourages providers to better distinguish aspects of cultural transition from psychopathology. Results underscored the importance of training mental health providers to ensure sensitivity to military culture. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Deployment Anxiety Reduction Training: A Pilot Study of Acceptability and Feasibility in Current or Recent Active Duty Service Members.

Objectives: The Deployment Anxiety Reduction Training (DART) is a manualized tool that was developed and piloted with active duty service members and recently deployed veterans regarding their response to potential and experienced acute combat stress reactions. DART is low risk and has high potential to be beneficial. It is a brief, one-session, non-pharmacological approach designed to reduce symptoms of peritraumatic panic and increase resilience in the face of a potentially traumatic stressor. Methods: This study was a mixed-methods pilot study to assess the utility and acceptability of DART during deployment. Results: Self-report and interview responses indicated that participants generally found the DART techniques acceptable and easy to understand. Overall, the techniques were perceived as likely to be helpful with high utility, although there was variation in perceived helpfulness among the different techniques. Participants overwhelmingly positively endorsed delivery of the DART protocol through use of smartphone technology. Conclusions: Results indicate that the DART components were considered highly acceptable and feasible for use in the deployed environment.