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Behavioral Intervention
Online Mind-Body Wellness Program for Chronic Conditions (EMPOwer Trial)
N/A
Recruiting
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
EMPOwer Trial Summary
This trial is testing a 12-week online program for adults ≥50 with chronic physical conditions to improve mental wellness and reduce anxiety/depression. The program includes mindful movement, breathwork, meditation and more.
Who is the study for?
Adults over 18 with chronic conditions like heart failure, liver cirrhosis, cancer survival, post-transplant recovery or kidney disease can join. They must speak English well enough for surveys and have internet plus a computer or smart device.Check my eligibility
What is being tested?
The trial tests an online mind-body wellness program against the same program with added weekly check-ins. It's to see if they help reduce anxiety and depression in people with various chronic illnesses over a 12-week period.See study design
What are the potential side effects?
Since this is a non-invasive mental wellness program involving activities like meditation and breathwork, no significant physical side effects are expected. Participants may experience emotional discomfort when addressing personal health issues.
EMPOwer Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a chronic condition like heart failure or cancer.
EMPOwer Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hospital Anxiety and Depression Scale (HADS)
Secondary outcome measures
Capability, Opportunity, Motivation, Behaviour (COM-B) Survey
EQ-5D-5L
Health Related Quality of Life
+2 moreOther outcome measures
Demoralization (Exploratory)
Edmonton Frail Scale (Exploratory)
Fried Frailty (Exploratory)
+2 moreEMPOwer Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Online Program + Weekly Check-insExperimental Treatment2 Interventions
Online program (mindful movement, meditation, breathwork, psychology-based coping skills program) + brief 1-to-1 weekly check-ins with a study team member
Group II: Online ProgramExperimental Treatment1 Intervention
Online program (mindful movement, meditation, breathwork, psychology-based coping skills program)
Group III: Waitlist ControlActive Control1 Intervention
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Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,453,067 Total Patients Enrolled
University of AlbertaLead Sponsor
889 Previous Clinical Trials
384,634 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a chronic condition like heart failure or cancer.I am 18 years old or older.I am unable to sign or understand the consent form.You have severe mental health issues like uncontrolled schizophrenia, PTSD, or bipolar disorder, unless your doctor or psychologist approves your participation.I am receiving end-of-life care.
Research Study Groups:
This trial has the following groups:- Group 1: Waitlist Control
- Group 2: Online Program
- Group 3: Online Program + Weekly Check-ins
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a recruitment phase for this research currently underway?
"Affirmative, clinicaltrials.gov lists this medical trial as actively recruiting participants. 500 individuals are needed from a single facility; the study was originally posted on February 12th 2023 and most recently updated March 24th of that same year."
Answered by AI
How many participants are taking part in this experiment?
"Affirmative. Clinicaltrials.gov's records demonstrate that this trial, initially posted on February 12th 2023, is actively recruiting patients at the moment. 500 individuals from a single centre are required for completion of the study."
Answered by AI
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