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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-22

Study Completion Date

2021-01-15

Brief Summary

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

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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.

Conditions

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Inflammatory Bowel Diseases Remission Perceived Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Sealed envelopes

Study Groups

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Stress Reduction Intervention

Participants will receive the standard of care for IBD and training and access to an online stress reduction intervention.

Group Type EXPERIMENTAL

Stress Reduction Intervention

Intervention Type 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.

Control

Participants will receive the standard of care for IBD.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stress Reduction Intervention

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* Adults (≥18 years)
* IBD
* on stable therapy for the past 3 months.

Exclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No