Status:
COMPLETED
Assessing the Effectiveness of a Stress Reduction Intervention in Inflammatory Bowel Disease (IBD)
Lead Sponsor:
University of Alberta
Conditions:
Inflammatory Bowel Diseases
Remission
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief 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 Co...
Eligibility Criteria
Inclusion
- Inclusion Criteria (RCT):
- Adults (≥18 years)
- with IBD in remission (UC - partial Mayo \<2 and fecal calprotectin \<250 μg/g; CD regular HBI \<5 or CRP \<8)
- on stable therapy for the past 3 months
- the last flare \<24 months prior to enrollment
- PSS-10 score ≥ 7 at time of screening
- Inclusion Criteria (Substudy):
- Adults (≥18 years)
- IBD
- on stable therapy for the past 3 months.
- Exclusion Criteria (RCT or Substudy):
- Major medical co-morbidity
- Steroid use in past 3 months
- Clostridium difficile infection in the last 3 months
- Unstable dose of psychiatric medications for the last 3 months
- Inability to provide informed written consent
- Severe psychiatric disorders (HADS scores \>10 or suicidal ideation)
Exclusion
Key Trial Info
Start Date :
February 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2021
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT03831750
Start Date
February 22 2019
End Date
January 15 2021
Last Update
May 13 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alberta
Edmonton, Alberta, Canada, T6G 2X8