Mindfulness for Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Mindfulness for Irritable Bowel Syndrome

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Based Cognitive Therapy (MBCT)
* Behavioral: Waiting Period


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Treatment Group<br>Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments. | Behavioral: Mindfulness Based Cognitive Therapy (MBCT)<br> <br> |
| Other: Delayed Treatment Group<br>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)<br> <br> Behavioral: Waiting Period<br> <br> |

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBS