Stephen H.A. Hernandez , Jacqueline Killian , Mark B. Parshall , Tonya Y. White , Enesha J. Hicks , Victoria Hughes , Theresa A. Bedford , Yiliang Zhu
{"title":"Increasing Resiliency in U.S. Air Force Personnel: A Multi-Site Trial Protocol","authors":"Stephen H.A. Hernandez , Jacqueline Killian , Mark B. Parshall , Tonya Y. White , Enesha J. Hicks , Victoria Hughes , Theresa A. Bedford , Yiliang Zhu","doi":"10.1016/j.conctc.2025.101507","DOIUrl":null,"url":null,"abstract":"<div><div>The purpose of this study is to examine the efficacy of the Stress Management and Resilience Training (SMART) in increasing the resilience of U.S. Air Force personnel. We aim to recruit up to 500 active component Air Force personnel and provide a two-arm randomization modality to make SMART more accessible and adaptive to the personnel's schedules. Two-arm randomization will be used to assign three sites for participants to choose in-person or computer-based training (CBT) and two sites where participants are randomized into their training type (in-person or CBT). The use of two-arm randomization will enable the examination of the difference between real-world settings within the framework of causal inference, as well as, differences based upon self-selection and a randomized control trial. We propose to examine the intervention effects at 12, 24 and 36-weeks post-intervention. Initial analysis will include descriptive statistics to characterize demographic status, military grade, duty location, and military occupation. The objectives of our analyses will include testing and estimating the intervention effects by comparing pre-post intervention changes in resilience, stress, anxiety, and QoL at each follow-up. Scores will also be pooled to test for overall intervention effects over time. Intervention effectiveness will be reported by comparing mean or median effects using 95 % confidence intervals and effect size estimates. An analysis of the longitudinal trend over the study period will be conducted by simultaneously examining data from all follow-ups using mixed-effects models in which random effects will be used to characterize between and within-subject variations.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101507"},"PeriodicalIF":1.4000,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S245186542500081X","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
The purpose of this study is to examine the efficacy of the Stress Management and Resilience Training (SMART) in increasing the resilience of U.S. Air Force personnel. We aim to recruit up to 500 active component Air Force personnel and provide a two-arm randomization modality to make SMART more accessible and adaptive to the personnel's schedules. Two-arm randomization will be used to assign three sites for participants to choose in-person or computer-based training (CBT) and two sites where participants are randomized into their training type (in-person or CBT). The use of two-arm randomization will enable the examination of the difference between real-world settings within the framework of causal inference, as well as, differences based upon self-selection and a randomized control trial. We propose to examine the intervention effects at 12, 24 and 36-weeks post-intervention. Initial analysis will include descriptive statistics to characterize demographic status, military grade, duty location, and military occupation. The objectives of our analyses will include testing and estimating the intervention effects by comparing pre-post intervention changes in resilience, stress, anxiety, and QoL at each follow-up. Scores will also be pooled to test for overall intervention effects over time. Intervention effectiveness will be reported by comparing mean or median effects using 95 % confidence intervals and effect size estimates. An analysis of the longitudinal trend over the study period will be conducted by simultaneously examining data from all follow-ups using mixed-effects models in which random effects will be used to characterize between and within-subject variations.
期刊介绍:
Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.