Adapting MOVED as a web-based moral elevation intervention for veterans with PTSD: Using feedback from a pilot trial and subject matter experts

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-02-06 DOI:10.1016/j.conctc.2025.101445

Adam P. McGuire , Alexander Riera , Xrystyan Lascano

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引用次数: 0

Abstract

Background

Alternative, easily accessible treatment options are needed to aid efforts to address the negative effects of PTSD among veterans. One approach that has shown promise in a pilot trial is a moral elevation-based intervention titled, MOVED. Qualitative feedback from veterans in the pilot trial identified several strengths, but also highlighted opportunities to improve the intervention. In this adaptation phase, we incorporated feedback from pilot participants with input from subject matter experts (SMEs) to inform adaptation decisions using the Model for Adaptation Design and Impact (MADI) framework. In this paper, we outline the process and final adaptations decisions in preparation for a future efficacy trial to assess the impact of MOVED on targeted outcomes for veterans with PTSD.

Method

We identified 10 SMEs that included veterans, clinicians, and researchers who participated in workgroup meetings to review 17 identified issues from the pilot and potential adaptations to address those concerns. We used the MADI framework to guide workgroup meeting discussions to determine what changes should be incorporated, including identifying potential negative outcomes for any adaptations and if they can be mitigated with other actions.

Results

SMEs agreed with proposed adaptations for 15 of 17 issues and proposed mitigating measures for four of those adaptations to avoid anticipated negative outcomes. Two proposed solutions were refuted and not selected for adaptation.

Conclusions

Using the MADI framework with input from SMEs allowed us to make informed decisions about adaptations for MOVED, thus contributing to further treatment development in preparation for a future efficacy trial.

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改编移动作为一个基于网络的道德提升干预创伤后应激障碍退伍军人：使用来自试点试验和主题专家的反馈

背景：为了帮助解决退伍军人创伤后应激障碍的负面影响，需要替代的、容易获得的治疗方案。一种在试点试验中显示出希望的方法是一种基于道德提升的干预措施，名为MOVED。在试点试验中，来自退伍军人的定性反馈确定了一些优势，但也强调了改进干预的机会。在这一适应阶段，我们将试点参与者的反馈与主题专家（sme）的意见结合起来，利用适应设计和影响模型（MADI）框架为适应决策提供信息。在本文中，我们概述了过程和最终的适应性决定，为未来的疗效试验做准备，以评估移动对PTSD退伍军人的目标结果的影响。方法我们确定了10家中小企业，其中包括退伍军人、临床医生和研究人员，他们参加了工作组会议，审查了从试点中发现的17个问题以及解决这些问题的潜在适应性。我们使用MADI框架来指导工作组会议讨论，以确定应该纳入哪些变化，包括确定任何适应的潜在负面结果，以及是否可以通过其他行动来减轻这些变化。结果：中小企业对17个问题中的15个问题提出了适应建议，并对其中4个问题提出了缓解措施，以避免预期的负面结果。提出的两种解决方案被反驳，没有被选择适应。使用MADI框架和来自中小企业的意见，使我们能够对move的适应性做出明智的决定，从而有助于进一步开发治疗方法，为未来的疗效试验做准备。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

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.