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

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

NCT ID: NCT05786482

Condition: Primary Biliary Cholangitis
Heart Failure
Digestive Diseases
Women Who Have Experienced a Cardiac Event
Cirrhosis, Liver
Post-Transplant
Cancer
Chronic Kidney Diseases
Other Chronic Physical Condition

Conditions: Official terms:
Cholangitis
Liver Cirrhosis, Biliary
Liver Cirrhosis
Digestive System Diseases
Gastrointestinal Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Cardiovascular Diseases
Disease

Conditions: Keywords:
Mind Body Wellness
Depression
Anxiety
Quality of Life
Wellbeing
Yoga
Meditation
Psychology

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Behavioral
Intervention name: Online mind-body wellness program
Description: Online program (mindful movement, meditation, breathwork, psychology-based coping skills program)
Arm group label: Online Program

Intervention type: Behavioral
Intervention name: Online mind-body wellness program + Weekly Check-ins
Description: Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief weekly check-ins
Arm group label: Online Program + Weekly Check-ins

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Alberta

Address:
City: Edmonton
Zip: T6G2X8
Country: Canada

Start date: February 12, 2023

Completion date: December 1, 2024

Lead sponsor:
Agency: University of Alberta
Agency class: Other

Collaborator:
Agency: Canadian Institutes of Health Research (CIHR)
Agency class: Other

Source: University of Alberta

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05786482