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

University of Alberta

Status: Completed

Conditions: Remission; Inflammatory Bowel Diseases; Perceived Stress

Treatments: Other: Stress Reduction Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03831750

Pro00082125 Pro00079377;

Details and patient eligibility

About

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

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

101 participants in 2 patient groups

Stress Reduction Intervention

Experimental group

Description:

Participants will receive the standard of care for IBD and training and access to an online stress reduction intervention.

Treatment:

Other: Stress Reduction Intervention

Control

No Intervention group

Description:

Participants will receive the standard of care for IBD.