Irritable Bowel Syndrome
Conditions
Keywords
IBS
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.
Interventions
BEHAVIORALWaiting Period
Sponsors
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 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 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 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 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 |
| 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 IBS quality of Life (IBS-QOL) | 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 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 |
| Change in IBS symptom Severity (GSRS - IBS) at Follow up | Baseline, Follow up (one month after the post assessment) | Self-Report Questionnaire |
| 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 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 |
Outcome results
None listed