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Completed

NCT Number: NCT02794376

Mindfulness for Irritable Bowel Syndrome

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mindfulness Based Cognitive Therapy (MBCT)

Behavioral

Waiting Period

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Acronym: MIBS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 9, 2016
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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