Behavioral Exposure for Interoceptive Tolerance (BE-FIT): A stage II randomized clinical trial protocol

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2024-10-09 DOI:10.1016/j.cct.2024.107706

Samantha G. Farris , Mindy M. Kibbey , Brittany Keller , Lilly Derby , Teresa M. Leyro , Brandon L. Alderman , Angelo M. DiBello , Michael B. Steinberg , Ana M. Abrantes

{"title":"Behavioral Exposure for Interoceptive Tolerance (BE-FIT): A stage II randomized clinical trial protocol","authors":"Samantha G. Farris , Mindy M. Kibbey , Brittany Keller , Lilly Derby , Teresa M. Leyro , Brandon L. Alderman , Angelo M. DiBello , Michael B. Steinberg , Ana M. Abrantes","doi":"10.1016/j.cct.2024.107706","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Exercise anxiety is a novel mechanism related to non-adherence to exercise and lifestyle physical activity. We developed a cognitive-behavioral treatment, Behavioral Exposure For Interoceptive Tolerance (BE-FIT), which is a manualized, values-based exposure intervention designed to target exercise anxiety that is delivered as a supplement to outpatient cardiac rehabilitation (CR).</div></div><div><h3>Method</h3><div>We describe a Stage II randomized controlled trial (RCT) to test BE-FIT, compared to a Health Education Control (HEC) intervention on exercise and physical activity outcomes at end-of-treatment (EOT) and follow-ups (Weeks 12, 18, and 24), and evaluate mechanisms of change (i.e., reductions in exercise anxiety). Adults (<em>N</em> = 146) who are ≥40 years of age, cleared for outpatient exercise-based CR, low active, and have elevated exercise anxiety will be recruited. The primary study hypothesis is that BE-FIT compared to HEC will result in higher levels of overall exercise and lifestyle physical activity at EOT and follow-ups. The second hypothesis is that BE-FIT vs HEC will produce greater reductions in exercise anxiety at EOT and Week 12. The third hypothesis is that reductions in exercise anxiety at EOT and Weeks 12 will mediate the effect of BE-FIT on activity outcomes at Weeks 18 and 24.</div></div><div><h3>Discussion</h3><div>We expect the results of this study will produce knowledge regarding BE-FIT's efficacy and mechanisms of action. Our goal is to better understand “how and why” the intervention is (or is not) effective and for whom, and increase collective knowledge and reproducibility of behavior change research.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"147 ","pages":"Article 107706"},"PeriodicalIF":2.0000,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714424002891","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Exercise anxiety is a novel mechanism related to non-adherence to exercise and lifestyle physical activity. We developed a cognitive-behavioral treatment, Behavioral Exposure For Interoceptive Tolerance (BE-FIT), which is a manualized, values-based exposure intervention designed to target exercise anxiety that is delivered as a supplement to outpatient cardiac rehabilitation (CR).

Method

We describe a Stage II randomized controlled trial (RCT) to test BE-FIT, compared to a Health Education Control (HEC) intervention on exercise and physical activity outcomes at end-of-treatment (EOT) and follow-ups (Weeks 12, 18, and 24), and evaluate mechanisms of change (i.e., reductions in exercise anxiety). Adults (N = 146) who are ≥40 years of age, cleared for outpatient exercise-based CR, low active, and have elevated exercise anxiety will be recruited. The primary study hypothesis is that BE-FIT compared to HEC will result in higher levels of overall exercise and lifestyle physical activity at EOT and follow-ups. The second hypothesis is that BE-FIT vs HEC will produce greater reductions in exercise anxiety at EOT and Week 12. The third hypothesis is that reductions in exercise anxiety at EOT and Weeks 12 will mediate the effect of BE-FIT on activity outcomes at Weeks 18 and 24.

Discussion

We expect the results of this study will produce knowledge regarding BE-FIT's efficacy and mechanisms of action. Our goal is to better understand “how and why” the intervention is (or is not) effective and for whom, and increase collective knowledge and reproducibility of behavior change research.

查看原文本刊更多论文

行为暴露促进感知间耐受（BE-FIT）：第二阶段随机临床试验方案。

背景：运动焦虑是一种与不坚持运动和生活方式体育锻炼有关的新机制。我们开发了一种认知行为疗法--行为暴露促进互感耐受（BE-FIT），这是一种针对运动焦虑开发的手动化、基于价值观的暴露干预，作为门诊心脏康复（CR）的补充疗法：我们介绍了一项第二阶段随机对照试验（RCT），该试验旨在测试 BE-FIT 与健康教育对照（HEC）干预相比，在治疗结束（EOT）和随访（第 12、18 和 24 周）时对运动和体育锻炼结果的影响，并评估变化机制（即运动焦虑的减轻）。将招募年龄≥40 岁、已获准接受门诊以运动为基础的 CR 治疗、运动量低且运动焦虑升高的成年人（N = 146）。主要研究假设是，与 HEC 相比，BE-FIT 将提高 EOT 和随访时的总体运动和生活方式体育锻炼水平。第二个假设是，BE-FIT 与 HEC 相比，将在 EOT 和第 12 周时更大程度地降低运动焦虑。第三个假设是，在 EOT 和第 12 周时，运动焦虑的减轻将调节 BE-FIT 对第 18 周和第 24 周活动结果的影响：我们希望这项研究的结果能让我们了解 BE-FIT 的疗效和作用机制。我们的目标是更好地了解干预 "如何以及为何 "有效（或无效），以及对谁有效，并增加行为改变研究的集体知识和可重复性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts 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 disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.