Web-based mindfulness and skills-based distress reduction for patients with cancer: study protocol of the multicentre, randomised, controlled confirmatory intervention trial Reduct.
Web-based mindfulness and skills-based distress reduction for patients with cancer: study protocol of the multicentre, randomised, controlled confirmatory intervention trial Reduct.
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DOI：
10.1136/bmjopen-2021-056973
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发表时间：
2022-06-01
期刊：
影响因子：
2.9
通讯作者：
Teufel, Martin
中科院分区：
文献类型：
--
作者：
Baeuerle, Alexander;Martus, Peter;Erim, Yesim;Schug, Caterina;Heinen, Jana;Krakowczyk, Julia Barbara;Steinbach, Jasmin;Damerau, Mirjam;Bethge, Wolfgang;Dinkel, Andreas;Dries, Sebastian;Mehnert-Theuerkauf, Anja;Neumann, Anja;Schadendorf, Dirk;Tewes, Mitra;Wiltink, Joerg;Wuensch, Alexander;Zipfel, Stephan;Graf, Johanna;Teufel, Martin
许多癌症患者经历严重的心理困扰，但由于各种障碍，他们中很少有人得到心理肿瘤支持。电子心理健康干预措施试图克服其中一些障碍和医疗保健服务的局限性，使癌症患者能够更好地科普心理困扰。在拟议的试验中，我们的目标是评估手动电子心理健康干预的有效性和成本效益，使其培训-基于正念和基于技能的减轻肿瘤痛苦。Make It Training是一种自我指导和基于网络的心理肿瘤干预，其中包括认知行为疗法，基于正念的减压以及接受和承诺疗法的元素。该培训为患者提供为期4个月的支持。我们预计，在完成干预后（T1，主要终点）减少痛苦方面，Make It Training上级常规优化治疗（TAU-O）。该研究包括一项多中心、前瞻性、随机对照、确证性干预试验，有两个平行组。拟定的试验包括四个不同的测量时间点：随机化前的基线评估、治疗后评估以及3个月和6个月的随访评估。我们将纳入在过去12个月内接受过癌症诊断、处于治愈性治疗环境中、年龄为18-65岁、已提供知情同意书并经历了至少1周的高度自觉心理困扰（医院焦虑和抑郁量表≥13）的患者。患者将随机分为两组（Make It vs TAU-O）。目的是分配600名癌症患者，并将556名纳入意向治疗分析。一旦完成干预（T1），将使用基线校正的ANCOVA分析主要终点（痛苦）的痛苦测量值，研究组作为二元因素，基线作为连续测量值，研究中心作为额外的分类协变量。埃森医学院伦理委员会已批准本研究（21-10076-BO）。研究结果将发表在同行评审期刊、会议报告、项目网站和自助组织中。德国临床试验注册中心（DRKS）; DRKS-ID：DRKS 00025213。
Many patients with cancer experience severe psychological distress, but as a result of various barriers, few of them receive psycho-oncological support. E-mental health interventions try to overcome some of these barriers and the limitation of healthcare offers, enabling patients with cancer to better cope with psychological distress. In the proposed trial, we aim to assess the efficacy and cost-effectiveness of the manualised e-mental health intervention Make It Training- Mindfulness-Based and Skills-Based Distress Reduction in Oncology. Make It Training is a self-guided and web-based psycho-oncological intervention, which includes elements of cognitive behavioural therapy, mindfulness-based stress reduction and acceptance and commitment therapy. The training supports the patients over a period of 4 months. We expect the Make It Training to be superior to treatment as usual optimised (TAU-O) in terms of reducing distress after completing the intervention (T1, primary endpoint). The study comprises a multicentre, prospective, randomised controlled confirmatory interventional trial with two parallel arms. The proposed trial incorporates four distinct measurement time points: the baseline assessment before randomisation, a post-treatment assessment and 3 and 6 month follow-up assessments. We will include patients who have received a cancer diagnosis in the past 12 months, are in a curative treatment setting, are 18–65 years old, have given informed consent and experience high perceived psychological distress (Hospital Anxiety and Depression Scale ≥13) for at least 1 week. Patients will be randomised into two groups (Make It vs TAU-O). The aim is to allocate 600 patients with cancer and include 556 into the intention to treat analysis. The primary endpoint, distress, will be analysed using a baseline-adjusted ANCOVA for distress measurement once the intervention (T1) has been completed, with study arm as a binary factor, baseline as continuous measurement and study centre as an additional categorical covariate. The Ethics Committee of the Medical Faculty Essen has approved the study (21-10076-BO). Results will be published in peer-reviewed journals, conference presentations, the project website, and among self-help organisations. German Clinical Trial Register (DRKS); DRKS-ID: DRKS00025213.
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