跳至主要内容
临床试验/NCT06002074
NCT06002074终止不适用

Impact of the Stress Management and Resilience Training (SMART) Program on Quality of Life in Patients with Inflammatory Bowel Diseases

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2023年9月28日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
Mayo Clinic
入组人数
17
试验地点
2
主要终点
Change in Inflammatory Bowel Disease (IBD) Quality of Life (QOL)

研究概览

简要总结

This research study is being done to look at the impact of a Stress Management and Resilience Training (SMART) Program on the quality of life and healthcare utilization of patients with inflammatory bowel disease.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • History of IBD defined by a physician global assessment (PGA) of quiescent, mild, moderate, or severe disease.
  • Access to internet/device such as smart phone, tablet, or computer
  • Patient reports stress as a trigger to their GI symptoms

排除标准

  • Corticosteroids in the previous 3 months
  • Elicit substance use (including medical marijuana)

结局指标

主要结局

Change in Inflammatory Bowel Disease (IBD) Quality of Life (QOL)

时间窗: Baseline, approximately 20 weeks

Measured by self-reported 32-item Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ) designed to assess feelings about symptoms as a results of IBD over the last 2 weeks. Responses to each question are scored on a 7-point Likert scale ranging from 1 (a very severe problem) to 7 (not a problem). Possible total scores range from 32 to 224, where higher scores indicate better outcome/better quality of life.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Victor Chedid

Principal Investigator

Mayo Clinic

研究点 (2)

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