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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831750
• Other study ID #: Pro00082125; Pro00079377
• Status: Completed
• Phase: N/A
• Start date: February 22, 2019
• Est. completion date: January 15, 2021

Study information

• Verified date: May 2021
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: January 15, 2021
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Perceived Stress
• Remission

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Bernstein CN, Singh S, Graff LA, Walker JR, Miller N, Cheang M. A prospective population-based study of triggers of symptomatic flares in IBD. Am J Gastroenterol. 2010 Sep;105(9):1994-2002. doi: 10.1038/ajg.2010.140. Epub 2010 Apr 6. — View Citation

Ritz T, Rosenfield D, St Laurent CD, Trueba AF, Werchan CA, Vogel PD, Auchus RJ, Reyes-Serratos E, Befus AD. A novel biomarker associated with distress in humans: calcium-binding protein, spermatid-specific 1 (CABS1). Am J Physiol Regul Integr Comp Physiol. 2017 Jun 1;312(6):R1004-R1016. doi: 10.1152/ajpregu.00393.2016. Epub 2017 Apr 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived stress	Between group changes in the stress index from baseline to end of study using the Cohen's Perceived Stress Scale (PSS)-10 item. Summed scores range from 0-40 where lower scores are associated with less perceived stress compared to higher scores.	3 months
Secondary	Mental health	Change from baseline to end of study using the Hospital and Anxiety Depression Scale (HADS). Summed scores (range: 0-21) are separate for anxiety and depression; lower scores are assocated with less perceived anxiety or depression.	3 months
Secondary	Health-related quality of life	Change from baseline to end of study using the: (1) Short IBD Quality of Life Questionnaire (SIBDQ). Scores (range 1-7) for the 7 questions are summed where higher scores related to a higher perceived health-related quality of life.	3 months
Secondary	Markers of inflammation and stress	Changes from baseline to end of study for 6 serum pro- and anti-inflammatory immune biomarkers relevant to IBD (IL-10, IL-12, IL-1ß, IL-4, IL-6, TNF-a) and markers of stress, including CABS1 and cortisol, with the Connor Davidson Resilience Scale (score range: 0 to 100). Higher scores with the Connor Davidson Resilience Scare are indicative of greater stress resiliency.	3 months
Secondary	IBD levels of activity	Changes from baseline to end of study for fecal calprotectin and Partial Mayo Score (score range 0-9; lower scores mean less or no disease activity) or the Harvey Bradshaw Index (HBI) (range=0-16+; where lower scores indicate less or no disease activity).	3 months