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Completed

NCT Number: NCT03831750

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

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

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Key information

Conditions

Inflammatory Bowel Diseases Behavior Behavioral Symptoms Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Perceived Stress Remission Stress, Psychological

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Perceived stress

    Time frame: 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 outcomes

  1. Mental health

    Time frame: 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.

  2. Health-related quality of life

    Time frame: 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.

  3. Markers of inflammation and stress

    Time frame: 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.

  4. IBD levels of activity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Feb 6, 2019
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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