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临床试验/NCT05786482
NCT05786482已完成不适用

Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions (EMPOwer) Randomized Controlled Trial

University of Alberta2 个研究点 分布在 1 个国家目标入组 825 人开始时间: 2023年2月12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
825
试验地点
2
主要终点
Hospital Anxiety and Depression Scale (HADS)

研究概览

简要总结

Chronic physical conditions are defined as conditions that require ongoing management and treatment over extended periods of time. Chronic physical conditions are not only leading causes of death and disability in North America but they are commonly associated with mental distress and reduced quality of life. Online mind-body wellness programming ranging from physical activity to mindfulness interventions has been shown to be effective in improving mental wellness in a variety of chronic disease populations, but there is a need to evaluate scalable ways to deliver these programs. Building upon a previously developed online wellness program for inflammatory bowel disease (IBD) and primary biliary cholangitis (PBC), the research team has developed a mind-body wellness program for adults ≥18 years of age living with different chronic conditions (e.g., cirrhosis, PBC, heart failure). The 12-week program will be delivered online, and include follow- along mindful movement, breathwork and meditation routines, and a psychology based coping skills program. In a three-armed randomized controlled trial, the study will assess the impact on the primary outcome of anxiety and depression as measured through the hospital anxiety and depression scale (HADS). At the beginning and the end of the 12-week research study, participants will complete surveys to assess secondary/exploratory outcome measures including quality of life, fatigue, frailty, demoralization, and healthcare usage.

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 eight weeks after the program ends to assess longer- term impacts on primary and secondary outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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 of age
  • Identified diagnosis of one of nine chronic conditions (Heart Failure, PBC, Digestive Disease, Cirrhosis, Cancer survivor, Post-transplant, Women who have experienced a cardiac event, Chronic Kidney Disease), or another general category for physical chronic conditions not captured by these nine
  • 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

  • Receiving compassionate care
  • Inability to provide informed written consent
  • Severe psychiatric disorders (presence of uncontrolled schizophrenia, post-traumatic stress disorder (PTSD), and/or bipolar disorder unless approved to participate by their physician/psychologist; suicidality nearly every day)
  • No access to the internet

研究组 & 干预措施

Waitlist Control

No Intervention

Online Program

Experimental

Online program (mindful movement, meditation, breathwork, psychology-based coping skills program)

干预措施: Online mind-body wellness program (Behavioral)

Online Program + Weekly Check-ins

Experimental

Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief 1-to-1 weekly check-ins with a study team member

干预措施: Online mind-body wellness program + Weekly Check-ins (Behavioral)

结局指标

主要结局

Hospital Anxiety and Depression Scale (HADS)

时间窗: 12 weeks

Depression and anxiety will be measured on the Hospital Anxiety and Depression Scale. The minimum value is 0, the maximum is 21, and higher scores mean a worse outcome.

次要结局

  • Modified Fatigue Impact Scale (MFIS)(12 weeks)
  • Health Related Quality of Life(12 weeks)
  • EQ-5D-5L(12 weeks)
  • Capability, Opportunity, Motivation, Behaviour (COM-B) Survey(12 weeks)
  • Satisfaction and Adherence(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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