Irritable Bowel SyndromeMIBSNCT02794376
Mindfulness for Irritable Bowel Syndrome
A study testing Mindfulness Based Cognitive Therapy (MBCT) and Waiting Period in people with Irritable Bowel Syndrome, run by University of Oxford.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Mindfulness Based Cognitive Therapy (MBCT) and Waiting Period
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2016to 10 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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).
About this study
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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Mindfulness Based Cognitive Therapy (MBCT), Waiting Period
- Keywords
- IBS
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive Therapy (MBCT)Behavioural
Waiting PeriodBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment Group | Experimental | Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments. Receives: Behavioral: Mindfulness Based Cognitive Therapy (MBCT) |
| Delayed Treatment Group | Other | Waiting period plus Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments after the waiting period has finished. Receives: Behavioral: Mindfulness Based Cognitive Therapy (MBCT); Behavioral: Waiting Period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IBS symptom Severity (GSRS - IBS)
Self-Report Questionnaire
Measured: Baseline and Post Intervention (within the first three weeks of completion or the intervention)
Secondary outcomes (18)
Changes in IBS quality of Life (IBS-QOL)
Self-Report Questionnaire
Measured: 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)
Changes in Psychological Distress (DASS)
Self-Report Questionnaire
Measured: 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)
Changes in Positive and Negative Emotions (PANAS)
Self-Report Questionnaire
Measured: 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)
Changes in IBS catastrophizing (GI-Cognitions Questionniare)
Self-Report Questionnaire
Measured: 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)
Changes in Visceral Anxiety Sensitivity (VSI)
Self-Report Questionnaire
Measured: 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)
Changes in Mindfulness (FFMQ-short)
Self-Report Questionnaire
Measured: 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)
Changes in Attentional Control (ANT)
Behavioural Computer-based task
Measured: 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)
Changes in Illness Identification (IAT)
Behavioural Computer-based task
Measured: 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)
Changes in Shame Identification (IAT)
Behavioural Computer-based task
Measured: 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)
Changes in Attention to Health Threat (Dot-probe)
Behavioural Computer-based task
Measured: 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)
Changes in Shame Association (SRET)
Behavioural Computer-based task
Measured: 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)
Change in IBS symptom Severity (GSRS - IBS) at Follow up
Self-Report Questionnaire
Measured: Baseline, Follow up (one month after the post assessment)
Changes in IBS quality of Life (IBS-QOL)
Self-Report Questionnaire
Measured: Baseline, (Follow up one month after the post assessment)
Baseline levels of Social Anxiety (SIAS-SPS)
Self-Report Questionnaire
Measured: Baseline
Baseline levels of Alexithymia (TAS-20)
Self-Report Questionnaire
Measured: Baseline
Baseline levels of Somatosensory Amplification (SSATS)
Self-Report Questionnaire
Measured: Baseline
Baseline levels of Thought Suppression (WBSI)
Self-Report Questionnaire
Measured: Baseline
Baseline levels of Rumination (RRS)
Self-Report Questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study start14 Apr 2016
- Primary completion10 Jul 2017
- Study completion10 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794376
- Sponsor's protocol ID
- 11626
- Acronym
- MIBS
- Status last verified
- Oct 2017
- First submitted
- 19 May 2016
- Last updated
- 27 Oct 2017
- Results posted
- No
Publications
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.
PubMed 32134291
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness for Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02794376
- Acronym / sponsor ID
- MIBS / 11626
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment Group | Experimental | Behavioral: Mindfulness Based Cognitive Therapy (MBCT)Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments. |
| Delayed Treatment Group | Other | Behavioral: Mindfulness Based Cognitive Therapy (MBCT), Behavioral: Waiting PeriodWaiting period plus Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments after the waiting period has finished. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Cognitive Therapy (MBCT) | Behavioural | Delayed Treatment Group, Immediate Treatment Group |
| Waiting Period | Behavioural | Delayed Treatment Group |
Primary outcome
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
18 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Change in IBS symptom Severity (GSRS - IBS) at Follow up
Time frame: Baseline, Follow up (one month after the post assessment)
Changes in IBS quality of Life (IBS-QOL)
Time frame: Baseline, (Follow up one month after the post assessment)
Baseline levels of Social Anxiety (SIAS-SPS)
Time frame: Baseline
Baseline levels of Alexithymia (TAS-20)
Time frame: Baseline
Baseline levels of Somatosensory Amplification (SSATS)
Time frame: Baseline
Baseline levels of Thought Suppression (WBSI)
Time frame: Baseline
Baseline levels of Rumination (RRS)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Derived from this study: PubMed 32134291Henrich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Cognitive Therapy (MBCT) and Waiting Period in people with Irritable Bowel Syndrome, run by University of Oxford.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IBS symptom Severity (GSRS - IBS) (time frame: Baseline and Post Intervention (within the first three weeks of completion or the intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02794376, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.