Mindfulness for Irritable Bowel Syndrome (MIBS)
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness Based Cognitive Therapy (MBCT)
Waiting Period
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring IBS
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Immediate Treatment Group
Delayed Treatment Group
Arm Description
Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments.
Waiting period plus Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments after the waiting period has finished.
Outcomes
Primary Outcome Measures
Change in IBS symptom Severity (GSRS - IBS)
Self-Report Questionnaire
Secondary Outcome Measures
Changes in IBS quality of Life (IBS-QOL)
Self-Report Questionnaire
Changes in Psychological Distress (DASS)
Self-Report Questionnaire
Changes in Positive and Negative Emotions (PANAS)
Self-Report Questionnaire
Changes in IBS catastrophizing (GI-Cognitions Questionniare)
Self-Report Questionnaire
Changes in Visceral Anxiety Sensitivity (VSI)
Self-Report Questionnaire
Changes in Mindfulness (FFMQ-short)
Self-Report Questionnaire
Changes in Attentional Control (ANT)
Behavioural Computer-based task
Changes in Illness Identification (IAT)
Behavioural Computer-based task
Changes in Shame Identification (IAT)
Behavioural Computer-based task
Changes in Attention to Health Threat (Dot-probe)
Behavioural Computer-based task
Changes in Shame Association (SRET)
Behavioural Computer-based task
Change in IBS symptom Severity (GSRS - IBS) at Follow up
Self-Report Questionnaire
Changes in IBS quality of Life (IBS-QOL)
Self-Report Questionnaire
Baseline levels of Social Anxiety (SIAS-SPS)
Self-Report Questionnaire
Baseline levels of Alexithymia (TAS-20)
Self-Report Questionnaire
Baseline levels of Somatosensory Amplification (SSATS)
Self-Report Questionnaire
Baseline levels of Thought Suppression (WBSI)
Self-Report Questionnaire
Baseline levels of Rumination (RRS)
Self-Report Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02794376
Brief Title
Mindfulness for Irritable Bowel Syndrome
Acronym
MIBS
Official Title
Mindfulness for Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 14, 2016 (Actual)
Primary Completion Date
July 10, 2017 (Actual)
Study Completion Date
July 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
IBS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate Treatment Group
Arm Type
Experimental
Arm Description
Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments.
Arm Title
Delayed Treatment Group
Arm Type
Other
Arm Description
Waiting period plus Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments after the waiting period has finished.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Cognitive Therapy (MBCT)
Intervention Type
Behavioral
Intervention Name(s)
Waiting Period
Primary Outcome Measure Information:
Title
Change in IBS symptom Severity (GSRS - IBS)
Description
Self-Report Questionnaire
Time Frame
Baseline and Post Intervention (within the first three weeks of completion or the intervention)
Secondary Outcome Measure Information:
Title
Changes in IBS quality of Life (IBS-QOL)
Description
Self-Report Questionnaire
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)
Title
Changes in Psychological Distress (DASS)
Description
Self-Report Questionnaire
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)
Title
Changes in Positive and Negative Emotions (PANAS)
Description
Self-Report Questionnaire
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)
Title
Changes in IBS catastrophizing (GI-Cognitions Questionniare)
Description
Self-Report Questionnaire
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)
Title
Changes in Visceral Anxiety Sensitivity (VSI)
Description
Self-Report Questionnaire
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)
Title
Changes in Mindfulness (FFMQ-short)
Description
Self-Report Questionnaire
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)
Title
Changes in Attentional Control (ANT)
Description
Behavioural Computer-based task
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)
Title
Changes in Illness Identification (IAT)
Description
Behavioural Computer-based task
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)
Title
Changes in Shame Identification (IAT)
Description
Behavioural Computer-based task
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)
Title
Changes in Attention to Health Threat (Dot-probe)
Description
Behavioural Computer-based task
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)
Title
Changes in Shame Association (SRET)
Description
Behavioural Computer-based task
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)
Title
Change in IBS symptom Severity (GSRS - IBS) at Follow up
Description
Self-Report Questionnaire
Time Frame
Baseline, Follow up (one month after the post assessment)
Title
Changes in IBS quality of Life (IBS-QOL)
Description
Self-Report Questionnaire
Time Frame
Baseline, (Follow up one month after the post assessment)
Title
Baseline levels of Social Anxiety (SIAS-SPS)
Description
Self-Report Questionnaire
Time Frame
Baseline
Title
Baseline levels of Alexithymia (TAS-20)
Description
Self-Report Questionnaire
Time Frame
Baseline
Title
Baseline levels of Somatosensory Amplification (SSATS)
Description
Self-Report Questionnaire
Time Frame
Baseline
Title
Baseline levels of Thought Suppression (WBSI)
Description
Self-Report Questionnaire
Time Frame
Baseline
Title
Baseline levels of Rumination (RRS)
Description
Self-Report Questionnaire
Time Frame
Baseline
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
12. IPD Sharing Statement
Citations:
PubMed Identifier
32134291
Citation
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.
Results Reference
derived
Learn more about this trial
Mindfulness for Irritable Bowel Syndrome
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