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

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

Detailed Description
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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.

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

Conditions
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Inflammatory Bowel Diseases, Remission, Perceived Stress

Intervention / Treatment
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* Other: Stress Reduction Intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress Reduction Intervention<br>Participants will receive the standard of care for IBD and training and access to an online stress reduction intervention. | Other: Stress Reduction Intervention<br>* 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.<br>|
| No Intervention: Control<br>Participants will receive the standard of care for IBD. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychological stress, Inflammatory bowel diseases, ulcerative colitis, remission, perceived stress, fecal calprotectin, salivary stress biomarker, stress reduction, Crohn's disease