NCT Number: NCT02794376
Mindfulness for Irritable Bowel Syndrome
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.
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
Waiting Period
BehavioralPrimary outcomes
-
Change in IBS symptom Severity (GSRS - IBS)
Time frame: Baseline and Post Intervention (within the first three weeks of completion or the intervention)
Self-Report Questionnaire
Secondary outcomes
-
Changes in IBS quality of Life (IBS-QOL)
Time frame: 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)
Self-Report Questionnaire
-
Changes in Psychological Distress (DASS)
Time frame: 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)
Self-Report Questionnaire
-
Changes in Positive and Negative Emotions (PANAS)
Time frame: 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)
Self-Report Questionnaire
-
Changes in IBS catastrophizing (GI-Cognitions Questionniare)
Time frame: 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)
Self-Report Questionnaire
-
Changes in Visceral Anxiety Sensitivity (VSI)
Time frame: 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)
Self-Report Questionnaire
-
Changes in Mindfulness (FFMQ-short)
Time frame: 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)
Self-Report Questionnaire
-
Changes in Attentional Control (ANT)
Time frame: 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)
Behavioural Computer-based task
-
Changes in Illness Identification (IAT)
Time frame: 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)
Behavioural Computer-based task
-
Changes in Shame Identification (IAT)
Time frame: 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)
Behavioural Computer-based task
-
Changes in Attention to Health Threat (Dot-probe)
Time frame: 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)
Behavioural Computer-based task
-
Changes in Shame Association (SRET)
Time frame: 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)
Behavioural Computer-based task
-
Change in IBS symptom Severity (GSRS - IBS) at Follow up
Time frame: Baseline, Follow up (one month after the post assessment)
Self-Report Questionnaire
-
Changes in IBS quality of Life (IBS-QOL)
Time frame: Baseline, (Follow up one month after the post assessment)
Self-Report Questionnaire
-
Baseline levels of Social Anxiety (SIAS-SPS)
Time frame: Baseline
Self-Report Questionnaire
-
Baseline levels of Alexithymia (TAS-20)
Time frame: Baseline
Self-Report Questionnaire
-
Baseline levels of Somatosensory Amplification (SSATS)
Time frame: Baseline
Self-Report Questionnaire
-
Baseline levels of Thought Suppression (WBSI)
Time frame: Baseline
Self-Report Questionnaire
-
Baseline levels of Rumination (RRS)
Time frame: Baseline
Self-Report Questionnaire
Sponsors and collaborators
Lead sponsor
University of Oxford
Other
Registry information
Acronym: MIBS
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Jun 9, 2016
- Registry last updated
- Oct 27, 2017
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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