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敏捷开发针对患有慢性肌肉骨骼疼痛的青少年的数字暴露治疗

2026年6月23日 更新者:Lauren Harrison、Stanford University

该项目拟采用连续重复和随机单病例实验设计(SCED),系统地开发和评估针对患有慢性肌肉骨骼疼痛的青少年的数字化分级暴露治疗的可行性和初步有效性。 SCED 提供了在个人层面严格评估治疗效果的机会。

iGET Living 的开发将基于一系列短期迭代,对患有慢性疼痛的青少年 (N = 15) 及其父母 (N = 15) 的小样本进行 alpha 测试(目标 1)。 对于目标 1,参与者将参加三个两小时的焦点小组(三周内每周一次),因此每个参与者总共参与目标 1 的时间为 6 个小时。

目标 2 将涉及幼稚最终用户样本(N = 20 名青少年,N = 20 名家长)。 参与者将在 7-25 天的基线期(这样做是为了支持 SCED 方法)进行登记,之后他们将参加为期 6 周的在线干预计划。 我们将在治疗出院后 3 个月(入组第 22 周)联系患者,并在此时完成自我报告结果测量。

研究概览

研究类型

介入性

注册 (实际的)

108

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

    • California
      • Menlo Park、California、美国、94025
        • Pediatric Pain Management Clinic

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

10年 至 17年 (孩子、成人)

接受健康志愿者

不

描述

纳入标准:

  • 10-17岁青少年
  • 诊断为慢性肌肉骨骼疼痛(>3 个月)
  • 有中度至高度疼痛干扰(PROMIS 疼痛干扰 ≥ 61)
  • 懂英语
  • 可以使用具有互联网连接的计算机、智能手机或平板电脑

排除标准:

  • 严重的认知障碍(例如脑损伤)
  • 会干扰治疗的重大医疗或精神问题

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:非随机化
  • 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
实验性的:分级暴露干预
对于目标 2,患有慢性疼痛的青少年将参加一项单臂可行性试验,检查一种新型、数字化、分级暴露治疗的可接受性、可行性和初步有效性。
分级暴露是一种理论驱动的、个体化的、基于证据的行为干预,针对慢性疼痛患者,通过让患者进行以前害怕和避免的活动来针对疼痛相关的损伤。
无干预:User centered development
For Aim 1, participants engaged with the prototypes of the intervention and provided feedback.

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
Assessment of Acceptability of Treatment Content - Likert Scale (Aim 1)
大体时间:One day
Participant-rated acceptability measured on 5-point Likert scale. Range 0-4 (higher scores indicate more acceptable). Questionnaire will be administered to youth with chronic pain and their parents.
One day
Participant Satisfaction With the Intervention (Aim 2)
大体时间:10 weeks (assessed at discharge)
Treatment satisfaction at the end of treatment will be evaluated by examining mean satisfaction scores on an adapted version of the Pain Service Satisfaction Test (PSST, McCracken et al., 1997). The PSST consists of 23 items rated on a 5-point Likert Scale (0 = not at all satisfied to 4 = very satisfied) and assesses the patient and parent's experience of the intervention. Scores range from 0-92. A score greater than/equal to 40 of 60 (satisfied to very satisfied) will indicate high levels of satisfaction with the intervention content. Caregivers were not assessed for this Outcome Measure.
10 weeks (assessed at discharge)
Percentage of Participants Dropped Out of Intervention (Aim 2)
大体时间:10 weeks (Completed at discharge)
As a measure of treatment adherence, we will calculate the percentage of participants who drop out or withdraw from the intervention prior to completion of the intervention.
10 weeks (Completed at discharge)
Expectations for Treatment (Aim 2)
大体时间:Assessed seven days after starting the intervention (7 days post-baseline)
To assess expectations for treatment effectiveness, participants completed the Credibility/Effectiveness Questionnaire (CEQ; Borkovec & Nau, 1972) after engaging with iGET Living for one week. The CEQ consists of six items rated on a 0 (not at all) to 10 (very much) Likert scale and assesses expectations related to the effects of the intervention across two subscales: Credibility (e.g., "How confident would you be recommending iGET Living to a friend with the same problems?") and Expectancy (e.g., "By the end of iGET Living, how much do you think your functioning will improve?"). Credibility is calculated by summing items 1-3 and Expectancy by summing items 4-6. Possible range of scores for each subscale is 0-30, with higher scores reflecting greater perceived credibility and expectancy.
Assessed seven days after starting the intervention (7 days post-baseline)
Functional Disability (Aim 2)
大体时间:Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
Functional disability will be assessed using the Functional Disability Inventory (FDI, Walker & Greene, 1991), a 15-item self-report measure of perceived difficulty in performing activities in school, home, physical, and social contexts. Items are rated on a 5-point Likert scale ranging from 0 (no trouble) to 4 (impossible). Scores from all the Items are summed to create a total score (range 0-60), with higher scores indicating greater disability.
Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)

次要结果测量

结果测量
措施说明
大体时间
Child Fear of Pain (Aim 2)
大体时间:Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
Fear of Pain Questionnaire, Child Report, Short Form (FOPQ-C-SF, Heathcote et al., 2020) is a 10-item self-report measure that assesses pain-related fear and avoidance of activities. Items are rated on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). Scores from all the Items are summed to create a total score ranging from 0 - 40. Higher scores indicate higher levels of pain-related fear and avoidance (worst outcome).
Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
Parental Fear of Pain (Aim 2)
大体时间:Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
The Parent Fear of Pain Questionnaire (PFOPQ, Simons et al., 2015) assesses parent's fear associated with their child's pain experiences. The PFOPQ contains 23 items assessed on a 5-point Likert scale (0 = "strongly disagree" to 4 "strongly agree"). Items are summed to create a total score (0-92), with higher scores indicated greater parent fear associated with their child's pain.
Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
Child Pain Catastrophizing (Aim 2)
大体时间:Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
The Pain Catastrophizing Scale -Child Version (PCS-C, Crombez et al., 2003) assesses negative cognitions associated with pain. The PCS-C is comprised of 13-items rated on a 5-point Likert scale (0= "not at all true" to 4 "very true"). A total score (0-52) is obtained by summing all items. Higher scores indicate higher levels of catastrophic thinking.
Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
Parent Pain Catastrophizing (Aim 2)
大体时间:Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
Pain Catastrophizing Scale-Parent Version (PCS-P, Goubert et al., 2006) assesses parents' negative cognitions associated with their child's pain. It is comprised of 13 items rated on a 5-point Likert scale (0 = "not true at all" to 4 = "very true"). A total score (0-52) is derived by summing items, with higher scores indicating higher levels of catastrophic thinking.
Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
Child Pain Acceptance (Aim 2)
大体时间:Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
Child report on the Chronic Pain Acceptance Questionnaire for Adolescents-short form (CPAQ-A8, Gauntlett-Gilbert et al., 2018) will be used to assess pain acceptance in the child. The CPAQ-A8 is an 8-item measure consisting of two subscales: Activity Engagement (4 items) and Pain Willingness (4 items). Items are rated on a 5-point Likert scale ranging from 0 (Never True) to 4 (Always True) and yield a total score for each subscale ranging from 0-16. Higher scores indicate greater Activity Engagement and greater Pain Willingness (positive outcome) .
Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
Parent Psychological Flexibility (Aim 2)
大体时间:Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
The Parent Psychological Flexibility Questionnaire (PPFQ-10, Timmers et al., 2019) is a 10-item parent self-report questionnaire assessing a parent's ability to accept their own distress and respond adaptively and flexibly to their child's pain. Items are rated on a 5-point Likert scale (0= " never true" to 4 = "always true") and are summed to create a total score, ranging from 0 - 40. Higher scores indicate greater parent psychological flexibility (positive outcome).
Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
Parent Responses to Childs Pain (Aim 2)
大体时间:Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
Adult Responses to Children's Symptoms (ARCS, Claar et al., 2010) assesses parents' behavioral responses to children's pain behaviors. The Protect subscale (13 items) will be utilized in this study. The Protect scale refers to protective parental behavior, such as giving the child special attention and limiting the child's normal activities and responsibilities. All items are rated on a 5-point Likert scale (0 = "never" to 4 "always"), and are averaged to create a total score ranging from 0-4. Higher scores indicating greater use of protective behavioral responses to their child's pain (worst outcome).
Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)

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。

调查人员

  • 首席研究员:Lauren E Harrison, PhD、Stanford University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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)

2022年5月2日

初级完成 (实际的)

2025年5月13日

研究完成 (实际的)

2025年10月1日

研究注册日期

首次提交

2021年10月4日

首先提交符合 QC 标准的

2021年10月4日

首次发布 (实际的)

2021年10月15日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年6月23日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 53323
  • 1K23AR079608-01 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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