NCT03831750

Assessing the Effectiveness of a Stress Reduction Intervention in Inflammatory Bowel Disease (IBD)

Assessing the Effectiveness of a Stress Reduction Intervention in Inflammatory Bowel Disease (IBD): a Prospective Randomized Controlled Trial (RCT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The investigators have designed a guided, online, tri-component, stress reduction intervention for participants with inflammatory bowel diseases.

Detailed description

In a randomized controlled trial, the investigators assessed the impact of an online, 3-month stress reduction intervention (yoga, breathwork, and meditation). The primary outcome was the change in Cohen's Perceived Stress Scale (PSS) between the control and intervention arms. The following secondary outcomes were also assessed: anxiety, depression, IBD disease activity (e.g., changes in CRP, fecal calprotectin, medication, hospitalization, or surgery), serum inflammatory markers, serum and salivary markers of stress, stress-resilience, and health- related quality of life. Participant satisfaction and adherence to the intervention were also evaluated.

Conditions

• Inflammatory Bowel Diseases
• Remission
• Perceived Stress

Interventions

Type	Name	Description
OTHER	Stress Reduction Intervention	The tri-component intervention is comprised of guided videos for breath-work (5-15 min), stretching (5-15 min), and meditation (10-30 min). The intervention will be delivered online via an access restricted website.

Timeline

• Start date: 2019-02-22
• Primary completion: 2020-03-01
• Completion: 2021-01-15
• First posted: 2019-02-06
• Last updated: 2021-05-13

Locations

1 site across 1 country: Canada