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Mindfulness for Irritable Bowel Syndrome (MIBS)

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness Based Cognitive Therapy (MBCT)
Waiting Period
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring IBS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Immediate Treatment Group

    Delayed Treatment Group

    Arm Description

    Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments.

    Waiting period plus Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments after the waiting period has finished.

    Outcomes

    Primary Outcome Measures

    Change in IBS symptom Severity (GSRS - IBS)
    Self-Report Questionnaire

    Secondary Outcome Measures

    Changes in IBS quality of Life (IBS-QOL)
    Self-Report Questionnaire
    Changes in Psychological Distress (DASS)
    Self-Report Questionnaire
    Changes in Positive and Negative Emotions (PANAS)
    Self-Report Questionnaire
    Changes in IBS catastrophizing (GI-Cognitions Questionniare)
    Self-Report Questionnaire
    Changes in Visceral Anxiety Sensitivity (VSI)
    Self-Report Questionnaire
    Changes in Mindfulness (FFMQ-short)
    Self-Report Questionnaire
    Changes in Attentional Control (ANT)
    Behavioural Computer-based task
    Changes in Illness Identification (IAT)
    Behavioural Computer-based task
    Changes in Shame Identification (IAT)
    Behavioural Computer-based task
    Changes in Attention to Health Threat (Dot-probe)
    Behavioural Computer-based task
    Changes in Shame Association (SRET)
    Behavioural Computer-based task
    Change in IBS symptom Severity (GSRS - IBS) at Follow up
    Self-Report Questionnaire
    Changes in IBS quality of Life (IBS-QOL)
    Self-Report Questionnaire
    Baseline levels of Social Anxiety (SIAS-SPS)
    Self-Report Questionnaire
    Baseline levels of Alexithymia (TAS-20)
    Self-Report Questionnaire
    Baseline levels of Somatosensory Amplification (SSATS)
    Self-Report Questionnaire
    Baseline levels of Thought Suppression (WBSI)
    Self-Report Questionnaire
    Baseline levels of Rumination (RRS)
    Self-Report Questionnaire

    Full Information

    First Posted
    May 19, 2016
    Last Updated
    October 25, 2017
    Sponsor
    University of Oxford
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02794376
    Brief Title
    Mindfulness for Irritable Bowel Syndrome
    Acronym
    MIBS
    Official Title
    Mindfulness for Irritable Bowel Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 14, 2016 (Actual)
    Primary Completion Date
    July 10, 2017 (Actual)
    Study Completion Date
    July 10, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Oxford

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome
    Keywords
    IBS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    67 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Immediate Treatment Group
    Arm Type
    Experimental
    Arm Description
    Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments.
    Arm Title
    Delayed Treatment Group
    Arm Type
    Other
    Arm Description
    Waiting period plus Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments after the waiting period has finished.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness Based Cognitive Therapy (MBCT)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Waiting Period
    Primary Outcome Measure Information:
    Title
    Change in IBS symptom Severity (GSRS - IBS)
    Description
    Self-Report Questionnaire
    Time Frame
    Baseline and Post Intervention (within the first three weeks of completion or the intervention)
    Secondary Outcome Measure Information:
    Title
    Changes in IBS quality of Life (IBS-QOL)
    Description
    Self-Report Questionnaire
    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)
    Title
    Changes in Psychological Distress (DASS)
    Description
    Self-Report Questionnaire
    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)
    Title
    Changes in Positive and Negative Emotions (PANAS)
    Description
    Self-Report Questionnaire
    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)
    Title
    Changes in IBS catastrophizing (GI-Cognitions Questionniare)
    Description
    Self-Report Questionnaire
    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)
    Title
    Changes in Visceral Anxiety Sensitivity (VSI)
    Description
    Self-Report Questionnaire
    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)
    Title
    Changes in Mindfulness (FFMQ-short)
    Description
    Self-Report Questionnaire
    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)
    Title
    Changes in Attentional Control (ANT)
    Description
    Behavioural Computer-based task
    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)
    Title
    Changes in Illness Identification (IAT)
    Description
    Behavioural Computer-based task
    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)
    Title
    Changes in Shame Identification (IAT)
    Description
    Behavioural Computer-based task
    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)
    Title
    Changes in Attention to Health Threat (Dot-probe)
    Description
    Behavioural Computer-based task
    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)
    Title
    Changes in Shame Association (SRET)
    Description
    Behavioural Computer-based task
    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)
    Title
    Change in IBS symptom Severity (GSRS - IBS) at Follow up
    Description
    Self-Report Questionnaire
    Time Frame
    Baseline, Follow up (one month after the post assessment)
    Title
    Changes in IBS quality of Life (IBS-QOL)
    Description
    Self-Report Questionnaire
    Time Frame
    Baseline, (Follow up one month after the post assessment)
    Title
    Baseline levels of Social Anxiety (SIAS-SPS)
    Description
    Self-Report Questionnaire
    Time Frame
    Baseline
    Title
    Baseline levels of Alexithymia (TAS-20)
    Description
    Self-Report Questionnaire
    Time Frame
    Baseline
    Title
    Baseline levels of Somatosensory Amplification (SSATS)
    Description
    Self-Report Questionnaire
    Time Frame
    Baseline
    Title
    Baseline levels of Thought Suppression (WBSI)
    Description
    Self-Report Questionnaire
    Time Frame
    Baseline
    Title
    Baseline levels of Rumination (RRS)
    Description
    Self-Report Questionnaire
    Time Frame
    Baseline

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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).

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32134291
    Citation
    Henrich JF, Gjelsvik B, Surawy C, Evans E, Martin M. A randomized clinical trial of mindfulness-based cognitive therapy for women with irritable bowel syndrome-Effects and mechanisms. J Consult Clin Psychol. 2020 Apr;88(4):295-310. doi: 10.1037/ccp0000483.
    Results Reference
    derived

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    Mindfulness for Irritable Bowel Syndrome

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