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

University of Alberta101 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

101

Conditions

Inflammatory Bowel Diseases Remission Perceived Stress

Interventions

Stress Reduction InterventionOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Alberta

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 3 months

Data from ClinicalTrials.gov

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