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临床试验/NCT04791527
NCT04791527已完成不适用

Assessing the Feasibility and Acceptability of a 12-week Online Stress Reduction/Wellness Intervention for Primary Biliary Cholangitis: a Pre-post Single-arm Interventional Study

University of Alberta2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Perceived Stress Scale

研究概览

简要总结

Primary biliary cholangitis (PBC) is a chronic autoimmune condition of the liver. Persons with PBC have high rates of liver disease-related symptoms and poor health-related quality of life - amongst the lowest of all chronic liver diseases. Patients and the Canadian PBC Society have identified the need for self-care tools to manage symptom burden. Building upon a previously developed online wellness program for inflammatory bowel disease (IBD), the researchers have developed a mind-body wellness module specific for patients with PBC. The 12 week module will be delivered online, and each week is made of an introduction video, 15-20 minutes of yoga, 10-15 minutes of meditation, behavior change tips, and nutrition tips. In a pre-post single arm feasibility study, the researchers will assess how acceptable this module is to patients through looking at rates of refusal, completion rates, and patient feedback. At the beginning and the end of the 12-week research study, participants will complete surveys to assess exploratory outcome measures including stress, anxiety, depression, resilience, quality of life, fatigue, and perceived ability to participate in the 12 week module. After the program, the research team will conduct interviews with participants to allow them to share their other feedback about the program. The researchers will also send surveys to the participants one month after the program ends to asses their continued satisfaction with and adherence to the program.

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

  • Adults (≥18 years)
  • Identified diagnosis of PBC
  • HADS score <=10
  • English language proficiency to complete questionnaires and read the educational material
  • Access to the Internet and a computer or smart device at home.

排除标准

  • Patients with a major medical co-morbidity
  • Inability to provide informed written consent
  • Severe psychiatric disorders (HADS scores >10)

结局指标

主要结局

Perceived Stress Scale

时间窗: 12 Weeks

The degree to which situations in one's life are appraised as stressful will be assessed using the Perceived Stress Scale. The minimum score is 0, the maximum score is 40, and higher scores indicate a worse outcome.

次要结局

  • Connor Davidson Resilience Scale 10(12 Weeks)
  • HADS Anxiety and Depression Scale(12 Weeks)
  • PBC-40(12 Weeks)
  • Modified Fatigue Impact Scale(12 Weeks)
  • Capability, Opportunity, Motivation, Behavior (COM-B) Survey(12 Weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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