A randomised controlled trial evaluating the efficacy of an app-delivered gut-directed hypnotherapy program in patients with irritable bowel syndrome

Not Applicable

• Conditions: Irritable Bowel Syndrome; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12622000698774
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-13
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

Participants must meets the ROME IV criteria for Irritable Bowel Syndrome

Exclusion Criteria

• Pregnancy
• Alcoholism
• Inability to understand the content of the sessions, because of insufficient command of the English language
• Inability to fill out the questionnaires
• Psychiatric condition (for example, severe depression, PTSD or psychosis)
• A combination of IBS and other chronic bowel diseases, such as ulcerative colitis, Crohn’s disease or coeliac disease
• Major surgery to the lower gastrointestinal tract, such as partial or total colectomy, small bowel resection or partial or total gastrectomy
• Past or present radiotherapy to the abdomen

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in gastrointestinal symptoms related to irritable bowel syndrome assessed by validated questionnaire - Irritable Bowel Syndrome - quality of life (IBS-QOL)[Baseline, Week 6 post intervention commencement (primary endpoint) and 6 months post finishing intervention ];Change in gastrointestinal symptoms related to irritable bowel syndrome assessed by validated questionnaire - IBS-symptom Severity Scale (IBS-SSS)[Baseline, Week 2, 4, and 6 post intervention commencement (primary endpoint) and 6 months post finishing intervention ];Change in gastrointestinal symptoms related to irritable bowel syndrome assessed by questionnaire - IBS Visual analogue scale (IBS-VAS)[Baseline, Week 1, 2, 3, 4, 5, and 6 post intervention commencement (primary endpoint) and 6 months post finishing intervention. ]

Secondary Outcome Measures

Name	Time	Method
Changes in psychological symptoms as assessed by validated questionnaires - Hospital Anxiety and Depression Scale (HADS)[Baseline, Week 1, 2, 3, 4, 5, and 6 post intervention commencement and 6 months post finishing intervention ];Changes in validated questionnaire Depression Anxiety Stress Scale (DASS) answers [Baseline, Week 1, 2, 3, 4, 5, and 6 post intervention commencement and 6 months post finishing intervention ];Changes in validated questionnaire Symptoms Check List-90-R (SCL-90-R) answers[Baseline, Week 1, 2, 3, 4, 5, and 6 post intervention commencement and 6 months post finishing intervention ];Changes in validated questionnaire Patient Health Questionnaire 4 (PHQ-4) answers [Baseline, Week 1, 2, 3, 4, 5, and 6 post intervention commencement and 6 months post finishing intervention ]