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

NCT03831750 | Completed

• 1 other identifier: Pro00082125; Pro00079377
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mental health

  3 months

• Health-related quality of life

  3 months

• Markers of inflammation and stress

  3 months

• IBD levels of activity

  3 months

Study Arms (2)

Stress Reduction Intervention

EXPERIMENTAL

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

Other: Stress Reduction Intervention

Control

NO INTERVENTION

Participants will receive the standard of care for IBD.

Interventions

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.

Stress Reduction Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Adults (≥18 years)
• IBD
• on stable therapy for the past 3 months.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2X8, Canada

Location

Related Publications (4)

• 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.

  PMID: 28381457 BACKGROUND

• 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.

  PMID: 20372115 BACKGROUND

• 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.

  PMID: 40243391 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. Therap Adv Gastroenterol. 2022 Sep 27;15:17562848221127238. doi: 10.1177/17562848221127238. eCollection 2022.

  PMID: 36187365 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Stress, Psychological; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Behavioral Symptoms; Behavior

Study Officials

• Farhad Peerani, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Puneeta Tandon, MD, MSc

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sealed envelopes
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 6, 2019
• Study Start: February 22, 2019
• Primary Completion: March 1, 2020
• Study Completion: January 15, 2021
• Last Updated: May 13, 2021

Record last verified: 2021-05

Locations

CA (1)