Clinical trial NCT02794376: Mindfulness for Irritable Bowel Syndrome
Official title: Mindfulness for Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: IBS
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2016-06-09
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Change in IBS symptom Severity (GSRS - IBS)
timeFrame: Baseline and Post Intervention (within the first three weeks of completion or the intervention)
Secondary outcomes:
measure: Changes in IBS quality of Life (IBS-QOL)
timeFrame: 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)
measure: Changes in Psychological Distress (DASS)
timeFrame: 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)
measure: Changes in Positive and Negative Emotions (PANAS)
timeFrame: 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)
measure: Changes in IBS catastrophizing (GI-Cognitions Questionniare)
timeFrame: 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)
measure: Changes in Visceral Anxiety Sensitivity (VSI)
timeFrame: 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)
measure: Changes in Mindfulness (FFMQ-short)
timeFrame: 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)
measure: Changes in Attentional Control (ANT)
timeFrame: 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)
measure: Changes in Illness Identification (IAT)
timeFrame: 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)
measure: Changes in Shame Identification (IAT)
timeFrame: 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)
measure: Changes in Attention to Health Threat (Dot-probe)
timeFrame: 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)
measure: Changes in Shame Association (SRET)
timeFrame: 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)
measure: Change in IBS symptom Severity (GSRS - IBS) at Follow up
timeFrame: Baseline, Follow up (one month after the post assessment)
measure: Changes in IBS quality of Life (IBS-QOL)
timeFrame: Baseline, (Follow up one month after the post assessment)
measure: Baseline levels of Social Anxiety (SIAS-SPS)
timeFrame: Baseline
measure: Baseline levels of Alexithymia (TAS-20)
timeFrame: Baseline
measure: Baseline levels of Somatosensory Amplification (SSATS)
timeFrame: Baseline
measure: Baseline levels of Thought Suppression (WBSI)
timeFrame: Baseline
measure: Baseline levels of Rumination (RRS)
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
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.