Clinical trial NCT03831750: Assessing the Effectiveness of a Stress Reduction Intervention in Inflammatory Bowel Disease (IBD)
Official title: Assessing the Effectiveness of a Stress Reduction Intervention in Inflammatory Bowel Disease (IBD): a Prospective Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Remission
Perceived Stress
Keywords: ulcerative colitis
remission
perceived stress
fecal calprotectin
salivary stress biomarker
psychological stress
stress reduction
Crohn's disease
Inflammatory bowel diseases
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility 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)

Primary outcomes:
measure: Perceived stress
timeFrame: 3 months
Secondary outcomes:
measure: Mental health
timeFrame: 3 months
measure: Health-related quality of life
timeFrame: 3 months
measure: Markers of inflammation and stress
timeFrame: 3 months
measure: IBD levels of activity
timeFrame: 3 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Farhad Peerani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Puneeta Tandon, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: Peerani F, Watt M, Ismond KP, Whitlock R, Ambrosio L, Hotte N, Mitchell N, Bailey RJ, Kroeker K, Dieleman LA, Siffledeen J, Lim A, Wong K, Halloran BP, Baumgart DC, Taylor L, Raman M, Madsen KL, Tandon P. A randomized controlled trial of a multicomponent online stress reduction intervention in inflammatory bowel disease. Therap Adv Gastroenterol. 2022 Sep 27;15:17562848221127238. doi: 10.1177/17562848221127238. eCollection 2022.