Yoga versus transdiagnostic cognitive behavioural therapy for emotional disorders in community-dwelling adults: Study protocol for a non-inferiority randomised controlled trial

IF 1.7 Q2 Medicine

Advances in integrative medicine Pub Date : 2025-04-02 DOI:10.1016/j.aimed.2025.100484

Danielle C. Mathersul , Jean M. Byrne , Joyce J.Y. Lau , Robert M. Schütze , Yvonne C. Learmonth , Hakuei Fujiyama , Kristin Naragon-Gainey , Peter M. McEvoy , Peter J. Bayley

{"title":"Yoga versus transdiagnostic cognitive behavioural therapy for emotional disorders in community-dwelling adults: Study protocol for a non-inferiority randomised controlled trial","authors":"Danielle C. Mathersul , Jean M. Byrne , Joyce J.Y. Lau , Robert M. Schütze , Yvonne C. Learmonth , Hakuei Fujiyama , Kristin Naragon-Gainey , Peter M. McEvoy , Peter J. Bayley","doi":"10.1016/j.aimed.2025.100484","DOIUrl":null,"url":null,"abstract":"<div><div>Cognitive behavioural therapy (CBT) is the first-line non-pharmacological intervention for the most prevalent and co-occurring mental health conditions (anxiety, major depressive, posttraumatic stress, and alcohol use disorders). However, CBT response rates are variable and access is limited by cost, availability, and up-take. Yoga demonstrates efficacy for these conditions and may be more accessible than CBT. However, to better refine personalised healthcare and ensure maximum generalisability to “real-world” presentations, we need methodologically robust randomised controlled trials (RCTs) that compare yoga to appropriate controls, monitor mental health co-occurrences, and examine biomarkers and mechanisms of action alongside outcomes. We present the study protocol for an ongoing, experimenter-masked, parallel-group, non-inferiority design RCT to evaluate the efficacy of 10-week yoga (novel intervention) versus 10-week transdiagnostic CBT (the <em>Unified Protocol</em>; evidence-based active control) for co-occurring anxiety, major depressive, posttraumatic stress, or alcohol use disorders among community-dwelling Australian adults (aged ≥18 years). The protocol is approved by Murdoch University Human Research Ethics Committee. The primary outcome measure is the Kessler Psychological Distress Scale (weeks 0, 11, 23, 35) and power analyses determined a minimum of 67 participants per group are required to assess non-inferiority. Secondary outcomes include a clinician-administered interview, self-reported symptoms, and functional outcomes. Sleep and emotion regulation self-report measures (including ecological momentary assessment) and physiological biomarkers (actigraphy, heart rate variability) will be tested as potential moderators and mediators of outcome. Experimenter-masked analyses will use both intent-to-treat and per-protocol approaches.</div></div><div><h3>Findings</h3><div>will inform evidence-based formal recommendations and policy regarding the implementation of yoga into healthcare and may advance precision medicine.</div></div>","PeriodicalId":7343,"journal":{"name":"Advances in integrative medicine","volume":"12 3","pages":"Article 100484"},"PeriodicalIF":1.7000,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in integrative medicine","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2212958825000436","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}

引用次数: 0

Abstract

Cognitive behavioural therapy (CBT) is the first-line non-pharmacological intervention for the most prevalent and co-occurring mental health conditions (anxiety, major depressive, posttraumatic stress, and alcohol use disorders). However, CBT response rates are variable and access is limited by cost, availability, and up-take. Yoga demonstrates efficacy for these conditions and may be more accessible than CBT. However, to better refine personalised healthcare and ensure maximum generalisability to “real-world” presentations, we need methodologically robust randomised controlled trials (RCTs) that compare yoga to appropriate controls, monitor mental health co-occurrences, and examine biomarkers and mechanisms of action alongside outcomes. We present the study protocol for an ongoing, experimenter-masked, parallel-group, non-inferiority design RCT to evaluate the efficacy of 10-week yoga (novel intervention) versus 10-week transdiagnostic CBT (the Unified Protocol; evidence-based active control) for co-occurring anxiety, major depressive, posttraumatic stress, or alcohol use disorders among community-dwelling Australian adults (aged ≥18 years). The protocol is approved by Murdoch University Human Research Ethics Committee. The primary outcome measure is the Kessler Psychological Distress Scale (weeks 0, 11, 23, 35) and power analyses determined a minimum of 67 participants per group are required to assess non-inferiority. Secondary outcomes include a clinician-administered interview, self-reported symptoms, and functional outcomes. Sleep and emotion regulation self-report measures (including ecological momentary assessment) and physiological biomarkers (actigraphy, heart rate variability) will be tested as potential moderators and mediators of outcome. Experimenter-masked analyses will use both intent-to-treat and per-protocol approaches.

Findings

will inform evidence-based formal recommendations and policy regarding the implementation of yoga into healthcare and may advance precision medicine.

查看原文本刊更多论文

瑜伽与跨诊断认知行为疗法治疗社区成人情绪障碍：一项非劣效性随机对照试验的研究方案

认知行为疗法（CBT）是最普遍和同时发生的精神健康状况（焦虑、重度抑郁、创伤后应激和酒精使用障碍）的一线非药物干预手段。然而，CBT的响应率是可变的，并且受成本、可用性和使用率的限制。瑜伽证明了对这些疾病的疗效，可能比认知行为疗法更容易获得。然而，为了更好地完善个性化医疗保健，并确保最大限度地推广到“现实世界”的演示，我们需要方法学上可靠的随机对照试验（rct），将瑜伽与适当的对照进行比较，监测心理健康的共同发生情况，并检查生物标志物和作用机制以及结果。我们提出了一项正在进行的、实验者隐藏的、平行组、非劣效性设计的随机对照试验的研究方案，以评估10周瑜伽（新干预）与10周跨诊断CBT(统一方案；循证主动控制)在澳大利亚社区居住成年人（年龄≥18岁）中共同发生的焦虑、重度抑郁、创伤后应激或酒精使用障碍。本协议经莫道克大学人类研究伦理委员会批准。主要结果测量是Kessler心理困扰量表（第0、11、23、35周），功率分析确定每组至少需要67名参与者来评估非劣效性。次要结局包括临床医生的访谈、自我报告的症状和功能结局。睡眠和情绪调节自我报告测量（包括生态瞬间评估）和生理生物标志物（活动记录仪，心率变异性）将作为结果的潜在调节和中介进行测试。实验者屏蔽分析将使用意向治疗和协议处理两种方法。研究结果将为在医疗保健中实施瑜伽的循证正式建议和政策提供信息，并可能推动精准医学的发展。

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

Advances in integrative medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-

CiteScore

3.20

自引率

11.80%

发文量

审稿时长

15 weeks

期刊介绍： Advances in Integrative Medicine (AIMED) is an international peer-reviewed, evidence-based research and review journal that is multi-disciplinary within the fields of Integrative and Complementary Medicine. The journal focuses on rigorous quantitative and qualitative research including systematic reviews, clinical trials and surveys, whilst also welcoming medical hypotheses and clinically-relevant articles and case studies disclosing practical learning tools for the consulting practitioner. By promoting research and practice excellence in the field, and cross collaboration between relevant practitioner groups and associations, the journal aims to advance the practice of IM, identify areas for future research, and improve patient health outcomes. International networking is encouraged through clinical innovation, the establishment of best practice and by providing opportunities for cooperation between organisations and communities.