Overview

This trial is active, not recruiting.

Condition irritable bowel syndrome
Treatments mindfulness based cognitive therapy (mbct), waiting period
Sponsor University of Oxford
Start date February 2016
End date May 2018
Trial size 30 participants
Trial identifier NCT02794376, 11626

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments.
mindfulness based cognitive therapy (mbct)
(Other)
Waiting period plus Mindfulness course consisting of six weekly two hour mindfulness sessions plus meditation homework assignments after the waiting period has finished.
mindfulness based cognitive therapy (mbct)
waiting period

Primary Outcomes

Measure
Change in IBS symptom Severity (GSRS - IBS)
time frame: 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)
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 catastrophizong (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

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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).

Additional Information

Official title Mindfulness for Irritable Bowel Syndrome
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Oxford.