Mindfulness for Irritable Bowel Syndrome
Not Applicable
Completed
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Behavioral: Mindfulness Based Cognitive Therapy (MBCT)Behavioral: Waiting Period
- Registration Number
- NCT02794376
- Lead Sponsor
- University of Oxford
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 67
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
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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).
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate Treatment Group Mindfulness Based Cognitive Therapy (MBCT) Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments. Delayed Treatment Group Mindfulness Based Cognitive Therapy (MBCT) Waiting period plus Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments after the waiting period has finished. Delayed Treatment Group Waiting Period Waiting period plus Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments after the waiting period has finished.
- Primary Outcome Measures
Name Time Method Change in IBS symptom Severity (GSRS - IBS) Baseline and Post Intervention (within the first three weeks of completion or the intervention) Self-Report Questionnaire
- Secondary Outcome Measures
Name Time Method Changes in IBS catastrophizing (GI-Cognitions Questionniare) 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 Attention to Health Threat (Dot-probe) 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 Baseline, Follow up (one month after the post assessment) Self-Report Questionnaire
Changes in IBS quality of Life (IBS-QOL) Baseline, (Follow up one month after the post assessment) Self-Report Questionnaire
Changes in Positive and Negative Emotions (PANAS) 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) 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 Shame Identification (IAT) 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 Visceral Anxiety Sensitivity (VSI) 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) 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) 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) 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
Baseline levels of Social Anxiety (SIAS-SPS) Baseline Self-Report Questionnaire
Baseline levels of Alexithymia (TAS-20) Baseline Self-Report Questionnaire
Baseline levels of Somatosensory Amplification (SSATS) Baseline Self-Report Questionnaire
Baseline levels of Thought Suppression (WBSI) Baseline Self-Report Questionnaire
Baseline levels of Rumination (RRS) Baseline Self-Report Questionnaire
Changes in Psychological Distress (DASS) 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