Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05786482
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2023-03-09
Brief Title:
Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions EMPOwer Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMPOwer
Brief 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 eg 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 secondaryexploratory 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None