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The investigators have designed a guided, online, tri-component, stress reduction intervention for participants with inflammatory bowel diseases.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stress Reduction Intervention | Experimental | Participants will receive the standard of care for IBD and training and access to an online stress reduction intervention. |
|
| Control | No Intervention | Participants will receive the standard of care for IBD. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress Reduction Intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Health-related quality of life |
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Inclusion Criteria (RCT):
Inclusion Criteria (Substudy):
Exclusion Criteria (RCT or Substudy):
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| Name | Affiliation | Role |
|---|---|---|
| Farhad Peerani, MD | University of Alberta | Principal Investigator |
| Puneeta Tandon, MD, MSc | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | T6G 2X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28381457 | Background | 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. | |
| 20372115 |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| D013315 | Stress, Psychological |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Sealed envelopes
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 |
| 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-α) 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 |
| 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 |
| 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. |
| 40243391 | Derived | Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3. |
| 36187365 | Derived | 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. Ther Adv Gastroenterol. 2022 Sep 27;15:17562848221127238. doi: 10.1177/17562848221127238. eCollection 2022. |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |