基于应用程序的躯体症状障碍和医学无法解释症状自我管理：一项试点研究
2026年5月27日 更新者：Jooyoung Oh、Gangnam Severance Hospital
探索管理躯体症状障碍与医学无法解释症状（MUS）应用的有效性：一项试点研究
目的 本研究的主要目的是评估一款为期八周的自我管理移动应用程序对患有躯体症状障碍（SSD）或医学无法解释症状（MUS）的成年人的有效性。 改善情况将使用PHQ-15进行评估。 次要目的是检查使用应用程序后临床症状和生理指标的变化，并评估干预的可接受性和可用性。
科学依据 无明显医学解释的躯体症状占初级保健就诊的15-30%（Peveler等人，1997；Fink等人，1999；Ko等人，2011）。 诊断术语已从DSM-IV中的躯体形式障碍和MUS演变为DSM-5中的SSD，强调伴随适应不良思想、情绪或行为的痛苦症状（Scott等人，2022）。 SSD常与述情障碍、情绪压抑和愤怒调节困难相关，这与躯体化作为未处理情感的身体表达理论一致（Anuk & Bahadir, 2017; Liu等人，2011）。 这些困难导致人际功能受损和过度医疗使用，常使临床医生感到挫败（Orzechowska等人，2020）。
心理治疗，包括CBT、MBSR、MBCT和ACT，已证明在减轻IBS、纤维肌痛、耳鸣和慢性疲劳等病症的症状负担方面有效（Hauge等人，2015；Kikuchi等人，2020；Roland等人，2015）。 这些疗法共享增强身心意识、减少生理过度唤醒以及促进适应性应对和接受等机制（Aktas等人，2019；Jing等人，2019）。 然而，传播障碍依然存在，因为SSD患者常拒绝心理解释、进行医疗购物并保持强烈的躯体归因（Brown, 2007；Harris等人，2009）。
数字干预通过以可访问的日常生活形式提供身心连接的心理教育、基于CBT和正念的策略、压力管理工具和行为监测，提供了可扩展的解决方案。 证据表明，基于互联网和应用程序的CBT程序可以改善躯体痛苦和相关结果，同时降低治疗成本并提高依从性（Van等人，2022）。
心率变异性（HRV）等生理测量提供了压力调节的客观生物标志物。 较低的HRV反映韧性降低和情绪失调加剧，而较高的HRV表明过度唤醒或恢复受损。 尽管自主神经调节与躯体化之间存在理论联系，但很少有研究在SSD人群中结合心理干预检查HRV反应。 本研究旨在填补这一空白。
研究设计 一项随机对照试验将招募110名年龄≥19岁、报告显著躯体痛苦的成年人。 经过筛选和知情同意后，参与者将使用独立于研究人员的R生成分配表，随机（1:1）分配到干预组（n=55）或对照组（n=55）。
基线评估包括标准化问卷和HRV测量。 干预组将使用移动应用程序八周，而对照组将继续常规治疗。 八周后，两组都将完成随访问卷和HRV测量。 随后，干预组将停止使用应用程序，对照组将被提供应用程序访问权限。 在16周时，将对两组进行额外的在线随访调查。
预期影响 本研究将为SSD和MUS的数字干预的有效性、可用性和可接受性提供实证证据。 通过将自我管理策略与生理监测相结合，旨在为在传统医疗模式中历来难以治疗的人群推进可扩展、基于证据的方法。
研究概览
研究类型
介入性
注册 (实际的)
46
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Seoul、韩国、06273
- Gangnam Severance Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 年龄在19岁或以上的成年人
- PHQ-15评分达到4分或更高
- 存在医学上无法解释的身体症状（MUS）
- 无显著的阅读或写作能力障碍
- 熟悉智能手机和互联网使用
排除标准：
- 当前诊断为物质使用障碍（酒精或药物）
- 当前诊断为精神分裂症或双相情感障碍，或存在临床医生认为会干扰参与的的精神症状
- 目前正在接受针对躯体症状的专门心理治疗
- 诊断为自闭症或智力残疾等发育障碍，或有明显认知障碍的证据
- 任何其他被临床医生认为不适合参与的医疗状况
- 因智能手机故障或缺乏足够的智能手机使用技能而无法继续参与
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：应用程序干预组
该组参与者将在接受常规护理的基础上，使用针对躯体症状障碍和医学无法解释症状的移动自我管理应用程序，为期8周。
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被分配到干预组的参与者将使用一款专为躯体症状障碍和医学无法解释症状患者设计的移动自我管理应用程序。
除了参与者的常规护理外，该应用程序在8周内提供心理教育、基于CBT和正念的治疗内容、压力管理工具以及行为监测。
对照组参与者将继续接受为期8周的常规治疗，且无法使用该移动应用程序。
在完成8周的主要终点后，他们将获得使用该移动应用程序的机会。
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无干预：等候名单对照组
该组参与者将在8周内继续按常规治疗，期间无法使用移动应用程序。
在8周的主要阶段结束后，他们将获得使用该应用程序的权限。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Somatic Symptom Severity (Patient Health Questionnaire-15; PHQ-15)
大体时间：Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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The primary outcome is the change in somatic symptom severity measured by the Patient Health Questionnaire-15 (PHQ-15).
The PHQ-15 is a 15-item self-report scale developed to assess the severity of somatic symptoms in primary care (Kroenke et al., 1998) and validated in psychiatric outpatient populations (Han et al., 2009).
Scores range from 0 to 30, with higher scores indicating greater somatic symptom burden.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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疾病态度量表（IAS）
大体时间：基线、干预开始后8周和干预开始后16周
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健康相关态度和担忧将使用疾病态度量表（IAS）进行测量。
IAS是一个包含27个项目的自我报告量表，用于评估疑病担忧、健康焦虑、疾病确信以及相关的疾病态度。
项目采用0-4分评分，分数越高反映与疾病相关的更负面或适应不良的态度和恐惧。
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基线、干预开始后8周和干预开始后16周
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Somatic Symptom Disorder B-Criteria Scale (SSD-12)
大体时间：Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Somatic symptom-related cognitive, affective, and behavioral distress will be assessed using the Somatic Symptom Disorder B-Criteria Scale (SSD-12).
The SSD-12 is a 12-item self-report measure that evaluates the psychological B-criteria of somatic symptom disorder, including excessive health-related thoughts, negative emotions, and maladaptive behaviors in response to somatic symptoms.
Each item is rated on a 0-4 scale, with higher scores indicating greater somatic symptom-related psychological distress.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Patient Health Questionnaire-9 (PHQ-9)
大体时间：Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Depressive symptoms will be measured using the Patient Health Questionnaire-9 (PHQ-9).
The PHQ-9 is a 9-item self-report scale that assesses the frequency of core depressive symptoms over the past week, with items rated from 0 ("not at all") to 3 ("nearly every day").
Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Generalized Anxiety Disorder-7 (GAD-7)
大体时间：Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7).
The GAD-7 is a 7-item self-report questionnaire that measures the severity of generalized anxiety symptoms over the past week, with each item rated from 0 ("not at all") to 3 ("nearly every day").
Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Liebowitz Social Anxiety Scale, Self-Rated (LSAS-SR)
大体时间：Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Social anxiety symptoms will be measured using the self-rated version of the Liebowitz Social Anxiety Scale (LSAS-SR).
The LSAS-SR consists of 20 items assessing fear and avoidance across a range of social and performance situations, with each item rated on 0-4 scales for fear and avoidance.
Higher scores reflect more severe social anxiety and greater avoidance of social situations.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Korean Version of the Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)
大体时间：Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Trait mindfulness will be assessed using the Korean version of the Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF).
The FFMQ-SF is a 15-item self-report scale that evaluates five facets of mindfulness: non-reactivity, observing, acting with awareness, describing, and nonjudging.
Items are rated on a 1-7 scale, with higher scores indicating higher levels of dispositional mindfulness across these facets.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Acceptance and Action Questionnaire-II (AAQ-II)
大体时间：Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Psychological acceptance will be measured using the Korean version of the Acceptance and Action Questionnaire-II (AAQ-II).
The AAQ-II is a self-report measure that assesses acceptance of internal experiences and willingness to act in line with values in the presence of difficult thoughts and feelings.
Items are rated on a Likert-type scale, and in the Korean scoring used in this study, higher scores indicate a higher level of acceptance and openness toward internal experiences.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Cognitive Emotion Regulation Questionnaire (CERQ)
大体时间：Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Cognitive emotion regulation strategies will be assessed using the Cognitive Emotion Regulation Questionnaire (CERQ).
The CERQ is a 35-item self-report measure that evaluates nine cognitive strategies used in response to negative life events, including acceptance, putting into perspective, positive refocusing, refocus on planning, positive reappraisal, self-blame, catastrophizing, other-blame, and rumination.
Items are rated on a 1-5 scale, with higher subscale scores indicating more frequent use of the corresponding cognitive emotion regulation strategy.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Intolerance of Uncertainty Scale - Short Form (IUS-12)
大体时间：Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Intolerance of uncertainty will be measured using the 12-item Intolerance of Uncertainty Scale - Short Form (IUS-12).
The IUS-12 assesses negative beliefs, distress, and difficulty functioning in situations involving ambiguity or uncertainty, with items rated on a 1-4 scale.
Higher scores indicate greater intolerance of uncertain or ambiguous situations.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Forms of Self-Criticism/Attacking and Self-Reassuring Scale (FSCRS)
大体时间：Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Self-criticism and self-reassurance will be assessed using the Korean version of the Forms of Self-Criticism/Attacking and Self-Reassuring Scale (FSCRS).
The FSCRS is an 18-item self-report measure that assesses two main dimensions: self-critical attitudes and self-reassuring responses toward oneself when facing setbacks or failures.
Items are rated on a 0-4 scale, with higher scores on self-criticism indicating more frequent self-attacking, and higher scores on self-reassurance indicating a greater ability to respond to oneself with kindness and support.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Korean Multidimensional Assessment of Interoceptive Awareness (K-MAIA)
大体时间：Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Interoceptive awareness will be assessed using the Korean Multidimensional Assessment of Interoceptive Awareness (K-MAIA).
The K-MAIA is a 32-item self-report scale that measures multiple dimensions of how individuals perceive and relate to internal bodily sensations, including noticing, attention regulation, emotional awareness, self-regulation, and body listening.
Items are rated on a 0-5 scale, with higher scores indicating more adaptive and accurate interoceptive awareness.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Korean Shapiro Control Inventory (K-SCI; Control and Desire for Control Subscales)
大体时间：Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Perceived control and desire for control will be measured using the Korean version of the Shapiro Control Inventory (K-SCI), focusing on the positive control, negative control, and desire for control subscales.
These subscales together comprise 24 items rated on a 1-7 scale and assess individuals' beliefs about their ability to exert control, their experiences of lacking control, and their motivation to maintain or increase control.
Higher scores on each subscale indicate stronger positive sense of control, greater negative control experiences, or greater desire for control, respectively.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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App Usability and Acceptability
大体时间：Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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Perceived usability and acceptability of the mobile application will be assessed using a 24-item self-report questionnaire adapted from prior work on smartphone-based interventions for serious mental illness.
Items are rated on a three-point scale (disagree, neutral, agree) and evaluate ease of use, perceived usefulness, satisfaction, and willingness to continue using or recommend the app.
Higher scores indicate greater perceived usability, acceptability, and perceived value of the digital intervention.
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Baseline, posttreatment assessment at week 6 with an allowable visit window from week 4 to week 8, and follow-up assessment at week 12 with an allowable visit window from week 10 to week 14
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年7月9日
初级完成 (实际的)
2025年8月30日
研究完成 (实际的)
2025年8月30日
研究注册日期
首次提交
2025年9月9日
首先提交符合 QC 标准的
2025年12月8日
首次发布 (实际的)
2025年12月22日
研究记录更新
最后更新发布 (实际的)
2026年5月29日
上次提交的符合 QC 标准的更新
2026年5月27日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- 3-2024-0119
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研究美国 FDA 监管的药品
不
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