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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
825
Online program (mindful movement, meditation, breathwork, psychology-based coping skills program)
Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief weekly check-ins
University of Alberta
Edmonton, Alberta, Canada
Hospital Anxiety and Depression Scale (HADS)
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.
Time frame: 12 weeks
Modified Fatigue Impact Scale (MFIS)
The Modified Fatigue Impact Scale (MFIS) assesses the effect of fatigue on cognitive functioning, physical functioning, and psychosocial functioning. The minimum value is 0, the maximum value is 84, and higher scores mean a worse outcome.
Time frame: 12 weeks
Health Related Quality of Life
Health related quality of life captured by the quality-of-life Short Form Survey 12 (SF-12). The minimum value is 0, the maximum value is 100, and a higher score means a better outcome.
Time frame: 12 weeks
EQ-5D-5L
Cost utility analysis will be facilitated by the EQ-5D-5L which consists of 5- dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) where patients are asked to indicate their health state. The minimum value is 5, the maximum value is 25, and a higher score means a worse outcome.
Time frame: 12 weeks
Capability, Opportunity, Motivation, Behaviour (COM-B) Survey
Capability, opportunity, and motivation for behaviour change will be measured on the COM-B survey. The lowest score is 0, the highest score is 60, and higher scores indicate better outcomes.
Time frame: 12 weeks
Satisfaction and Adherence
Satisfaction and adherence will be measured using a self-report tool where participants indicate their satisfaction with program elements, and perceived adherence to the program over the study period. The minimum value is 4, the maximum value is 40, and a higher score means a better outcome.
Time frame: 12 weeks
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