此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Advancing Online Psychology Tools for Chronic Pain (ADOPT-CP)

2026年6月15日 更新者:Women's College Hospital

Advancing Online Psychology Tools for Chronic Pain (ADOPT-CP): Feasibility of a Scalable Digital Psychology Intervention and AI-Powered Support for Patients on the Waitlist for Pain Services

Chronic pain affects more than 20% of Canadians and is associated with significant impacts on physical function, mental health, and quality of life. Despite efforts to improve access to multidisciplinary pain care through centralized referral systems, many patients continue to experience prolonged wait times before receiving treatment.

This study evaluates a self-guided digital psychological intervention designed to support chronic pain self-management during the waiting period for specialized pain care. The intervention was developed through a collaboration between the Transitional Pain Service and ManagingLife and aims to improve access to evidence-based psychological support, enhance self-management skills, and reduce pain-related distress among individuals living with chronic pain.

研究概览

详细说明

The Advancing Online Psychology Tools for Chronic Pain (ADOPT-CP) intervention provides participants with access to the Manage My Pain (MMP) platform, including a self-guided Acceptance and Commitment Therapy (ACT)-based digital psychology program and Solace, an artificial intelligence (AI)-enabled conversational support tool for chronic pain. Together, these tools are designed to support pain self-management, emotional coping, and engagement in care.

This study will evaluate the feasibility, acceptability, and preliminary clinical effects of the ADOPT-CP intervention among individuals waiting to access multidisciplinary chronic pain services through the Toronto Academic Pain Medicine Institute (TAPMI). The intervention aims to provide accessible psychological support and self-management resources during the waiting period for specialized pain care.

研究类型

介入性

注册 (估计的)

60

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。

学习联系方式

研究联系人备份

学习地点

    • Ontario
      • Toronto、Ontario、加拿大、M5S 1B2
        • Women's College Hospital

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

Inclusion Criteria:

  1. Must be deemed to have capacity to provide informed consent;
  2. Must sign and date the informed consent form;
  3. Must state willingness to comply with all study procedures;
  4. Must be at least 18 years of age;
  5. Must be referred to TAPMI;
  6. Must have either fibromyalgia or chronic pelvic pain
  7. Must be on the waitlist at TAPMI;
  8. Must have access to a device that can connect to the Internet with access to email.

Exclusion Criteria:

  1. Currently engaged in psychotherapy or engaged in psychotherapy within the last month at the time of enrolment;
  2. Unable to read, understand, or communicate in English sufficiently to provide informed consent and complete the study procedures and questionnaires;
  3. Has active serious mental illness or psychiatric instability that, in the opinion of the research team, may impair the ability to safely participate in the study or to provide informed consent (e.g., active psychosis, active mania);
  4. Has a visual, auditory, or other functional impairment that would prevent independent access to and use of the digital intervention and study procedures on an internet-enabled device.

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:支持治疗
  • 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
实验性的:Intervention Group
The ADOPT-CP intervention includes the Manage My Pain (MMP) app with integrated tools: a customizable pain tracker for monitoring symptoms and generating reports, the Pain Guide with educational content on pain management, a self-guided Acceptance and Commitment Therapy (ACT)-based psychology program, and Solace, an AI-driven conversational agent designed to provide structured, evidence-based psychological support for chronic pain self-management.
The intervention, Manage My Pain (MMP), is a clinically validated app-based platform that supports individuals with chronic pain in self-managing their symptoms and improving communication and engagement with their care team.
有源比较器:Control Group
The control group will receive treatment as usual plus weekly emailed resources. These resources include materials introduced during the TAPMI orientation session, including Power Over Pain and Progress Over Pain.
Weekly emailed pain self-management resources introduced during the Toronto Academic Pain Medicine Institute (TAPMI) orientation

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
Trial feasibility
大体时间:10 weeks
Measured according to the CONSORT criteria and include: eligibility rate, recruitment rate, retention rate, measure completion, absence of or minor adverse events.
10 weeks
Engagement with the digital ADOPT-CP intervention
大体时间:10 weeks
Measured via MMP app analytics (usage rates, completion of psychology program, etc.)
10 weeks
Acceptability and Appropriateness of the ADOPT-CP intervention
大体时间:10 weeks
The Treatment Evaluation Inventory-Short Form (TEI-SF) is a self-report measure assessing the acceptability and perceived appropriateness of a treatment or intervention, with higher scores indicating greater treatment acceptability.
10 weeks
Acceptability and Adherence of the ADOPT-CP intervention
大体时间:10 weeks
The Treatment Acceptability/Adherence Scale (TAAS) is a self-report measure assessing perceived acceptability of an intervention and anticipated or actual adherence, with higher scores indicating greater acceptability and adherence.
10 weeks
Experience using the ADOPT-CP intervention
大体时间:14 weeks
a semi-structured interview guide will be used to explore participant experiences, barriers and facilitators to use, acceptability, engagement, and opportunities to refine the digital intervention prior to a larger trial.
14 weeks

次要结果测量

结果测量
措施说明
大体时间
Quality of Life and Pain Interference
大体时间:10 weeks

Modified PROMIS-29 Health Domains (Quality of Life and Pain Interference 8a): A validated patient-reported outcome system assessing the impact of health conditions on physical, mental, and social functioning.

Higher scores indicate greater pain interference and worse health-related quality of life, while lower scores indicate better functioning and quality of life.

10 weeks
Pain Acceptance
大体时间:10 weeks

Measured by the Chronic Pain Acceptance Questionnaire-Short Form: A validated self-report measure of acceptance of chronic pain.

Higher scores indicate greater acceptance of chronic pain, including continued activity engagement and reduced avoidance of pain-related experiences.

10 weeks
Psychological Flexibility
大体时间:10 weeks

Measured by the Acceptance and Action Questionnaire-II (AAQ-II): A validated self-report measure of psychological inflexibility and experiential avoidance.

Higher scores indicate greater psychological inflexibility and experiential avoidance, while lower scores indicate greater psychological flexibility.

10 weeks
Kinesiophobia
大体时间:10 weeks
Measured by the Tampa Scale of Kinesiophobia (TSK): a validated self-report questionnaire used to assess fear of movement and fear of re-injury. Higher scores indicate greater fear of movement.
10 weeks
Pain Resiliency
大体时间:10 weeks

Measured by the Pain Resiliency Scale: Measures how well a person can adapt and maintain function despite chronic pain.

Higher scores indicate greater resilience in coping with chronic pain, while lower scores indicate reduced adaptive coping.

10 weeks

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:Tania Di Renna, MD, FRCPC、Women's College Hospital

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 (估计的)

2026年10月1日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2028年3月1日

研究注册日期

首次提交

2026年6月15日

首先提交符合 QC 标准的

2026年6月15日

首次发布 (实际的)

2026年6月22日

研究记录更新

最后更新发布 (实际的)

2026年6月22日

上次提交的符合 QC 标准的更新

2026年6月15日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

At this time, no external data sharing arrangements or future secondary use arrangements are planned. Study data will be retained and used only for the purposes described in this protocol. If future secondary use or collaboration with internal or external investigators is proposed at a later date, this would occur only in accordance with participant consent, WCH REB requirements, and any required data sharing agreements or institutional approvals.

Results from this study may be disseminated through academic publications, presentations, and reports. Only aggregate or de-identified information will be used for these purposes. No participant-identifiable information will be included in any publication or dissemination arising from this study. Study data will not be shared with individuals outside the research team for secondary use.

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

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.

订阅