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

March 5, 2024 updated by: University of Alberta

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2X8
        • Recruiting
        • University of Alberta
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Waitlist Control
Experimental: Online Program
Online program (mindful movement, meditation, breathwork, psychology-based coping skills program)
Behavioral: Online mind-body wellness program
Online program (mindful movement, meditation, breathwork, psychology-based coping skills program)
Experimental: Online Program + Weekly Check-ins
Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief 1-to-1 weekly check-ins with a study team member
Behavioral: Online mind-body wellness program + Weekly Check-ins
Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief weekly check-ins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Canadian Institutes of Health Research (CIHR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2023

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00122568

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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