Mindfulness for Irritable Bowel Syndrome

NCT02794376 | Completed

• 1 other identifier: 11626
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Irritable Bowel Syndrome

Keywords

IBS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Changes in IBS quality of Life (IBS-QOL)

  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)

  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)

  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)

  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)

  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)

Study Arms (2)

Immediate Treatment Group

EXPERIMENTAL

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

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.

Behavioral: Mindfulness Based Cognitive Therapy (MBCT); Behavioral: Waiting Period

Interventions

Mindfulness Based Cognitive Therapy (MBCT) BEHAVIORAL

Delayed Treatment Group; Immediate Treatment Group

Waiting Period BEHAVIORAL

Delayed Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Participants speaks English fluently or at a native level
• Participant has normal or corrected to normal vision

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Oxford: lead

Related Publications (1)

• 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.

  PMID: 32134291 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: June 9, 2016
• Study Start: April 14, 2016
• Primary Completion: July 10, 2017
• Study Completion: July 10, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10