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

Cancer Clinical Trial

— EMPOwer  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786482
• Other study ID #: Pro00122568
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Alberta
• Contact: Puneeta Tandon, MD, MSc
• Phone: 780-492-9844
• Email: ptandon[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cardiovascular Diseases
• Cholangitis
• Chronic Kidney Diseases
• Cirrhosis, Liver
• Digestive Diseases
• Digestive System Diseases
• Disease
• Gastrointestinal Diseases
• Heart Failure
• Kidney Diseases
• Liver Cirrhosis
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Online mind-body wellness program
Online program (mindful movement, meditation, breathwork, psychology-based coping skills program)
• Online mind-body wellness program + Weekly Check-ins
Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief weekly check-ins

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demoralization (Exploratory)	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
Other	Edmonton Frail Scale (Exploratory)	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
Other	Fried Frailty (Exploratory)	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
Other	Healthcare Usage (Exploratory)	Healthcare usage will be measured using a self-report tool where participants indicate healthcare service usage during the study period.	12 weeks
Other	Sleep (Exploratory)	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
Primary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks