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Behavioral Intervention

Online Mind-Body Wellness Program for Chronic Conditions (EMPOwer Trial)

N/A

Waitlist Available

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

Must not have

Inability to provide informed written consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a chronic condition like heart failure or cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unable to sign or understand the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hospital Anxiety and Depression Scale (HADS)

Secondary study objectives

Capability, Opportunity, Motivation, Behaviour (COM-B) Survey

EQ-5D-5L

Health Related Quality of Life

+2 more

Other study objectives

Demoralization (Exploratory)

Edmonton Frail Scale (Exploratory)

Fried Frailty (Exploratory)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 2Eligibility criteria met