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Mindfulness for Irritable Bowel Syndrome (MIBS)

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ClinicalTrials.gov Identifier: NCT02794376
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Behavioral: Mindfulness Based Cognitive Therapy (MBCT) Behavioral: Waiting Period Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness for Irritable Bowel Syndrome
Actual Study Start Date : April 14, 2016
Actual Primary Completion Date : July 10, 2017
Actual Study Completion Date : July 10, 2017

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



Primary Outcome Measures :
  1. Change in IBS symptom Severity (GSRS - IBS) [ Time Frame: Baseline and Post Intervention (within the first three weeks of completion or the intervention) ]
    Self-Report Questionnaire


Secondary Outcome Measures :
  1. Changes in IBS quality of Life (IBS-QOL) [ 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) ]
    Self-Report Questionnaire

  2. Changes in Psychological Distress (DASS) [ 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) ]
    Self-Report Questionnaire

  3. Changes in Positive and Negative Emotions (PANAS) [ 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) ]
    Self-Report Questionnaire

  4. Changes in IBS catastrophizing (GI-Cognitions Questionniare) [ 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) ]
    Self-Report Questionnaire

  5. Changes in Visceral Anxiety Sensitivity (VSI) [ 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) ]
    Self-Report Questionnaire

  6. Changes in Mindfulness (FFMQ-short) [ 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) ]
    Self-Report Questionnaire

  7. Changes in Attentional Control (ANT) [ 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) ]
    Behavioural Computer-based task

  8. Changes in Illness Identification (IAT) [ 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) ]
    Behavioural Computer-based task

  9. Changes in Shame Identification (IAT) [ 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) ]
    Behavioural Computer-based task

  10. Changes in Attention to Health Threat (Dot-probe) [ 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) ]
    Behavioural Computer-based task

  11. Changes in Shame Association (SRET) [ 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) ]
    Behavioural Computer-based task

  12. Change in IBS symptom Severity (GSRS - IBS) at Follow up [ Time Frame: Baseline, Follow up (one month after the post assessment) ]
    Self-Report Questionnaire

  13. Changes in IBS quality of Life (IBS-QOL) [ Time Frame: Baseline, (Follow up one month after the post assessment) ]
    Self-Report Questionnaire

  14. Baseline levels of Social Anxiety (SIAS-SPS) [ Time Frame: Baseline ]
    Self-Report Questionnaire

  15. Baseline levels of Alexithymia (TAS-20) [ Time Frame: Baseline ]
    Self-Report Questionnaire

  16. Baseline levels of Somatosensory Amplification (SSATS) [ Time Frame: Baseline ]
    Self-Report Questionnaire

  17. Baseline levels of Thought Suppression (WBSI) [ Time Frame: Baseline ]
    Self-Report Questionnaire

  18. Baseline levels of Rumination (RRS) [ Time Frame: Baseline ]
    Self-Report Questionnaire



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02794376     History of Changes
Other Study ID Numbers: 11626
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by University of Oxford:
IBS

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases