Mindfulness for Irritable Bowel Syndrome
Not Applicable
Completed
- Conditions
- Irritable Bowel Syndrome
- 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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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