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NCT Number: NCT05786482

Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions

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.

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Key information

Conditions

Primary Biliary Cholangitis Anxiety Disorders Behavior Behavioral Symptoms Bile Duct Diseases Biliary Tract Diseases Cancer Cardiovascular Diseases Cholestasis Cholestasis, Intrahepatic Chronic Disease Chronic Kidney Diseases Cirrhosis, Liver Depression Digestive Diseases Digestive System Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Heart Diseases Heart Failure Kidney Diseases Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Male Urogenital Diseases Mental Disorders Neoplasms Other Chronic Physical Condition Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Transplant Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Women Who Have Experienced a Cardiac Event

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G2X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Online Mind-Body Wellness Program

Behavioral

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

Online mind-body wellness program + Weekly Check-ins

Behavioral

Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief weekly check-ins

Primary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

Secondary outcomes

  1. Modified Fatigue Impact Scale (MFIS)

    Time frame: 12 weeks

    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.

  2. Health Related Quality of Life

    Time frame: 12 weeks

    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.

  3. EQ-5D-5L

    Time frame: 12 weeks

    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.

  4. Capability, Opportunity, Motivation, Behaviour (COM-B) Survey

    Time frame: 12 weeks

    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.

  5. Satisfaction and Adherence

    Time frame: 12 weeks

    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.

Other outcomes

  1. Demoralization (Exploratory)

    Time frame: 12 weeks

    Demoralization will be captured through self report using the Demoralization Scale-II. The minimum score is 0, the maximum score is 32, and a higher score means a worse outcome.

  2. Edmonton Frail Scale (Exploratory)

    Time frame: 12 weeks

    Frailty will be captured using the Edmonton Frail Scale. The minimum score is 0, the maximum score is 17, and a higher score means a worse outcome.

  3. Fried Frailty (Exploratory)

    Time frame: 12 weeks

    Frailty will be captured using the Fried Frailty Score. The minimum score is 0, the maximum score is 5, and a higher score means a worse outcome.

  4. Healthcare Usage (Exploratory)

    Time frame: 12 weeks

    Healthcare usage will be measured using a self-report tool where participants indicate healthcare service usage during the study period.

  5. Sleep (Exploratory)

    Time frame: 12 weeks

    Impacts on sleep will be captured through self-report using the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8a. The minimum score is 8, the maximum score is 56, and a lower score means a worse outcome.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Acronym: EMPOwer

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2023
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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