Mindfulness for Irritable Bowel Syndrome (MIBS)

This study investigates the effectiveness of a 6 week mindfulness intervention in reducing symptoms of Irritable Bowel Syndrome (IBS). All Participants will receive treatment. Participants will be randomly allocated to an immediate treatment group and a waiting list control group.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Behavioral: Mindfulness Based Cognitive Therapy (MBCT); Behavioral: Waiting Period

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the study.
• Diagnosed with IBS by Gastroenterologist or General Practioner (GP), meeting Rome III criteria for IBS, symptom onset at least 6 months prior to inclusion, discomfort or pain at least 2-3 days per month
• Participants speaks English fluently or at a native level
• Participant has normal or corrected to normal vision

Exclusion Criteria:

• Participant has insufficient manual dexterity for the computerized tasks
• Severe Diagnostic and Statistical Manual (DSM) Axis I or II psychiatric disorder (diagnosis of dementia, amnesia, delirium, a dissociative disorder, a personality disorder, schizophrenia or any other psychotic disorder, a substance-related or induced disorder (such as alcoholism), attention deficit hyperactivity disorder (ADHD), attention deficit disorder (ADD), primary diagnosis of obsessive compulsive disorder (OCD), current suicidality, regular non-suicidal self-injury.
• Recent bereavement (within one year)
• GI diagnosis other than IBS (IBD, coeliac disease, another FGID)
• Pregnancy
• No access to the internet
• Prior participation in an 8-week mindfulness course (MBSR, MBCT) or any other structured mindfulness training. Prior participation in Vipassana meditation courses. Regular meditation practice (meditating more than once per month).
• Not able or unwilling to commit to amount of practice (sessions and home practice).
• Participant is currently enrolled in another IBS treatment study (psychological or pharmacological).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Treatment Group; Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments.	Behavioral: Mindfulness Based Cognitive Therapy (MBCT)
Other: Delayed Treatment Group; Waiting period plus Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments after the waiting period has finished.	Behavioral: Mindfulness Based Cognitive Therapy (MBCT); Behavioral: Waiting Period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in IBS symptom Severity (GSRS - IBS)	Self-Report Questionnaire	Baseline and Post Intervention (within the first three weeks of completion or the intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in IBS quality of Life (IBS-QOL)	Self-Report Questionnaire	Baseline and Post Intervention Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention)
Changes in Psychological Distress (DASS)	Self-Report Questionnaire	Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention)
Changes in Positive and Negative Emotions (PANAS)	Self-Report Questionnaire	Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention)
Changes in IBS catastrophizing (GI-Cognitions Questionniare)	Self-Report Questionnaire	Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention)
Changes in Visceral Anxiety Sensitivity (VSI)	Self-Report Questionnaire	Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention)
Changes in Mindfulness (FFMQ-short)	Self-Report Questionnaire	Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention)
Changes in Attentional Control (ANT)	Behavioural Computer-based task	Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention)
Changes in Illness Identification (IAT)	Behavioural Computer-based task	Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention)
Changes in Shame Identification (IAT)	Behavioural Computer-based task	Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention)
Changes in Attention to Health Threat (Dot-probe)	Behavioural Computer-based task	Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention)
Changes in Shame Association (SRET)	Behavioural Computer-based task	Baseline and Post Intervention (within the first three weeks of completion or the intervention), Mid-Intervention (after 2 weeks of the start of the intervention)
Change in IBS symptom Severity (GSRS - IBS) at Follow up	Self-Report Questionnaire	Baseline, Follow up (one month after the post assessment)
Changes in IBS quality of Life (IBS-QOL)	Self-Report Questionnaire	Baseline, (Follow up one month after the post assessment)
Baseline levels of Social Anxiety (SIAS-SPS)	Self-Report Questionnaire	Baseline
Baseline levels of Alexithymia (TAS-20)	Self-Report Questionnaire	Baseline
Baseline levels of Somatosensory Amplification (SSATS)	Self-Report Questionnaire	Baseline
Baseline levels of Thought Suppression (WBSI)	Self-Report Questionnaire	Baseline
Baseline levels of Rumination (RRS)	Self-Report Questionnaire	Baseline

Collaborators and Investigators

• Sponsor: University of Oxford

Publications and helpful links

General Publications

• Henrich JF, Gjelsvik B, Surawy C, Evans E, Martin M. A randomized clinical trial of mindfulness-based cognitive therapy for women with irritable bowel syndrome-Effects and mechanisms. J Consult Clin Psychol. 2020 Apr;88(4):295-310. doi: 10.1037/ccp0000483.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2016
• Primary Completion (Actual): July 10, 2017
• Study Completion (Actual): July 10, 2017

Study Registration Dates

• First Submitted: May 19, 2016
• First Submitted That Met QC Criteria: June 3, 2016
• First Posted (Estimate): June 9, 2016

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: IBS
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: 11626