Inflammatory Bowel Diseases, Perceived Stress, Remission
Conditions
Keywords
ulcerative colitis, remission, perceived stress, fecal calprotectin, salivary stress biomarker, psychological stress, stress reduction, Crohn's disease, Inflammatory bowel diseases
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.
Interventions
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.
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Sealed envelopes
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived stress | 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Mental health | 3 months | 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 | 3 months | 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 | 3 months | 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 | 3 months | 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). |
Countries
Canada
Outcome results
None listed