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临床试验/NCT05847881
NCT05847881已完成不适用

Toward Thriving: A Set of Reflective Tools to Empower Chronic Pain Patients and Help Them Envision a Personal Path to Thriving.

University of Michigan2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2023年4月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Participants Engaged in the Interventions

研究概览

简要总结

The purpose of this study is to introduce and test the usefulness of a reflective process meant to empower people with chronic pain and help support participant's resiliency and thriving.

The study team hypothesizes that:

-Greater or equal to 80 percent of participants will report that the intervention was relatively easy to understand after orientation, low burden, potentially effective, and will have completed at least 2 of the 3 reflective tools.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Persistent or recurrent pain lasting longer than 3 months
  • Able to read and write English

排除标准

  • Cancer (History of any bone-related cancer or cancer that metastasized to the bone; Currently in treatment for any cancer or plan to start cancer treatment in the next 12 months; History of any cancer treatment in the last 24 months)
  • Active substance abuse
  • Uncontrolled depression or psychosis
  • Visual or hearing difficulties that would preclude participation
  • Individuals started receiving disability or compensation within the past year, or currently involved in litigation
  • Current/planned (in the next 2 years) enrollment in another study of a device or investigational drug that would interfere with this study, this may include participation in a blinded trial.
  • Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators. This would include but not be limited to severe psychiatric disorders, active suicidal ideations or history of suicide attempts, and an uncontrolled drug and/or alcohol addiction)

研究组 & 干预措施

Reflective process group

Experimental

干预措施: Self-guided at home activities (Behavioral)

结局指标

主要结局

Participants Engaged in the Interventions

时间窗: Baseline (T1) to Exit Interview (T4), up to 68 days

The timepoints were as follows: consent and survey (T1), Kick-off Meeting (T2), Workshop (T3), and Exit Interview (T4). Participants had to attend the Kick-off Meeting (T2) to be considered engaged in the intervention. Participants who did not attend the Kick-off Meeting (T2) were withdrawn. Participants who did not attend the Workshop (T3) could still attend the Exit Interview (T4).

次要结局

  • Patient Global Impression of Change (PGIC) at T4 Exit Interview(at T4 Exit Interview, up to 68 days)
  • Change in Pain Interference Based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Version 2.0 Between Baseline (t1) and Approximately 68 Days (t4 Exit Interview)(Up to 68 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hannah Smotrich

Associate Professor of Art and Design

University of Michigan

研究点 (2)

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