Mindfulness for Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

— MIBS  

Official title:

Mindfulness for Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794376
• Other study ID #: 11626
• Status: Completed
• Phase: N/A
• First received: May 19, 2016
• Last updated: October 25, 2017
• Start date: April 14, 2016
• Est. completion date: July 10, 2017

Study information

• Verified date: October 2017
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 10, 2017
• Est. primary completion date: July 10, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Behavioral:
• Mindfulness Based Cognitive Therapy (MBCT)

• Waiting Period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in IBS symptom Severity (GSRS - IBS)	Self-Report Questionnaire	Baseline and Post Intervention (within the first three weeks of completion or the intervention)
Secondary	Changes in IBS quality of Life (IBS-QOL)	Self-Report Questionnaire	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)
Secondary	Changes in Psychological Distress (DASS)	Self-Report Questionnaire	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)
Secondary	Changes in Positive and Negative Emotions (PANAS)	Self-Report Questionnaire	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)
Secondary	Changes in IBS catastrophizing (GI-Cognitions Questionniare)	Self-Report Questionnaire	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)
Secondary	Changes in Visceral Anxiety Sensitivity (VSI)	Self-Report Questionnaire	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)
Secondary	Changes in Mindfulness (FFMQ-short)	Self-Report Questionnaire	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)
Secondary	Changes in Attentional Control (ANT)	Behavioural Computer-based task	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)
Secondary	Changes in Illness Identification (IAT)	Behavioural Computer-based task	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)
Secondary	Changes in Shame Identification (IAT)	Behavioural Computer-based task	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)
Secondary	Changes in Attention to Health Threat (Dot-probe)	Behavioural Computer-based task	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)
Secondary	Changes in Shame Association (SRET)	Behavioural Computer-based task	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)
Secondary	Change in IBS symptom Severity (GSRS - IBS) at Follow up	Self-Report Questionnaire	Baseline, Follow up (one month after the post assessment)
Secondary	Changes in IBS quality of Life (IBS-QOL)	Self-Report Questionnaire	Baseline, (Follow up one month after the post assessment)
Secondary	Baseline levels of Social Anxiety (SIAS-SPS)	Self-Report Questionnaire	Baseline
Secondary	Baseline levels of Alexithymia (TAS-20)	Self-Report Questionnaire	Baseline
Secondary	Baseline levels of Somatosensory Amplification (SSATS)	Self-Report Questionnaire	Baseline
Secondary	Baseline levels of Thought Suppression (WBSI)	Self-Report Questionnaire	Baseline
Secondary	Baseline levels of Rumination (RRS)	Self-Report Questionnaire	Baseline