Back to resultsAssessing the Effectiveness of a Stress Reduction Intervention in Inflammatory Bowel Disease (IBD)
Primary Purpose
Inflammatory Bowel Diseases, Remission, Perceived Stress
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Stress Reduction Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Inflammatory Bowel Diseases focused on measuring ulcerative colitis, remission, perceived stress, fecal calprotectin, salivary stress biomarker, psychological stress, stress reduction, Crohn's disease, Inflammatory bowel diseases
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)
Sites / Locations
- University of Alberta
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Stress Reduction Intervention
Control
Arm Description
Participants will receive the standard of care for IBD and training and access to an online stress reduction intervention.
Participants will receive the standard of care for IBD.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03831750
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
January 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Sealed envelopes
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stress Reduction Intervention
Arm Type
Experimental
Arm Description
Participants will receive the standard of care for IBD and training and access to an online stress reduction intervention.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will receive the standard of care for IBD.
Intervention Type
Other
Intervention Name(s)
Stress Reduction Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perceived stress
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mental health
Description
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.
Time Frame
3 months
Title
Health-related quality of life
Description
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.
Time Frame
3 months
Title
Markers of inflammation and stress
Description
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.
Time Frame
3 months
Title
IBD levels of activity
Description
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).
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farhad Peerani, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Puneeta Tandon, MD, MSc
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
28381457
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.
Results Reference
background
PubMed Identifier
20372115
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.
Results Reference
background
PubMed Identifier
36187365
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.
Results Reference
derived
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Assessing the Effectiveness of a Stress Reduction Intervention in Inflammatory Bowel Disease (IBD)
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