Agile development of a digital exposure treatment for youth with chronic musculoskeletal pain: protocol of a user-centred design approach and examination of feasibility and preliminary efficacy.
Agile development of a digital exposure treatment for youth with chronic musculoskeletal pain: protocol of a user-centred design approach and examination of feasibility and preliminary efficacy.
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DOI：
10.1136/bmjopen-2022-065997
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发表时间：
2022-09-15
期刊：
影响因子：
2.9
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中科院分区：
文献类型：
--
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慢性疼痛影响到大量儿童，影响多个领域，包括社会、情感和行为功能，并对家庭功能产生负面影响。大约5%患有慢性疼痛的青少年经历中度至重度疼痛相关的残疾，与疼痛相关的恐惧和避免活动被确定为治疗参与的实质性障碍。证据支持有针对性的心理和身体干预措施来解决这些障碍（例如，分级暴露治疗），但干预的可及性受到城市地区以外服务短缺，治疗相关费用高以及长期供应商等待名单的影响;强调需要开发数字化交付的行为干预，使用敏捷和迭代的研究设计，支持快速开发和及时传播。本研究旨在为患有慢性疼痛的青少年及其护理人员制定有效且可扩展的干预措施。本文提出了一个以用户为中心的协议，为青年和照顾者的数字暴露治疗的发展和完善，以及研究设计，以检查使用单例实验设计（SCED）的治疗的可行性和初步疗效。评估包括从基线和整个干预期间（约6周）和3个月随访时完成的每日日记，以及在基线、干预结束和3个月随访时完成的自我报告测量。主要结局包括治疗满意度、治疗预期、坚持每日日记和功能障碍。次要结局是疼痛相关的恐惧和活动回避，疼痛灾难化和疼痛接受。我们将根据SCED报告指南进行描述性和基于模型的推断分析。我们将计算每个个体对每个结果的效应量。我们将检查平均治疗预期、可信度和满意度评分以及患者脱落率。本研究由斯坦福大学的机构审查委员会批准（方案编号53323）。研究结果将通过同行评审期刊、会议报告和社交媒体积极传播。NCT 05079984。
Chronic pain affects a significant number of children and impacts multiple domains including social, emotional and behavioural functioning, and negatively impacts family functioning. Roughly 5% of youth with chronic pain experience moderate to severe pain-related disability, with pain-related fear and avoidance of activities being identified as substantial barriers to treatment engagement. Evidence supports targeted psychological and physical interventions to address these barriers (eg, graded-exposure treatment), but accessibility to intervention is undermined by a shortage of services outside of urban areas, high treatment-related costs, and long provider waitlists; highlighting the need to develop digitally delivered behavioural intervention, using agile and iterative study designs that support rapid development and timely dissemination. This study seeks to develop an effective and scalable intervention for youth with chronic pain and their caregivers. This paper presents a user-centred protocol for the development and refinement of a digital exposure treatment for youth and caregivers, as well as the study design to examine feasibility and preliminary efficacy of the treatment using single-case experimental design (SCED). Assessments include daily diaries, completed from baseline and daily throughout the intervention (~6 weeks), and at 3-month follow-up, as well as self-report measures completed at baseline, end of intervention and 3-month follow-up. Primary outcomes include treatment satisfaction, treatment expectancy, adherence to daily dairies and functional disability. Secondary outcomes are pain-related fear and avoidance of activities, pain catastrophising and pain acceptance. We will present descriptive and model-based inference analyses, based on SCED reporting guidelines. We will calculate effect sizes for each individual on each outcome. We will examine mean treatment expectancy, credibility and satisfaction scores, and patient drop-out percentage. This study is approved by the Institutional Review Board at Stanford University (protocol #53323). Findings will be actively disseminated through peer-reviewed journals, conference presentations and social media. NCT05079984.
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