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

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: App‐delivered gut‐directed hypnotherapy and psycho‐education using voice recording and readings which will take approximately 20 minutes per day for participants to complete across the 6 week duration of the study. The gut‐directed hypnotherapy and psycho‐education are resources already available through the Nerva app and involve education of around Irritable Bowel Syndrome and calming hypnotherapy sessions to help relax the patient. Participants will receive weekly text messages at the end of the week to remind them to continue completing the programfor the 6 weeks on the intervention and additionally at 6 months to complete follow up surveys. CONDITION: Oral and Gastrointestinal ‐ Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon Irritable Bowel Syndrome; ; Irritable Bowel Syndrome PRIMARY OUTCOME: 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 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 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: 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 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 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 ] 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 ] INCLUSION CRITERIA: Participants must meets the ROME IV criteria for Irritable Bowel Syndrome
Epistemonikos ID: 71da66f2ee70e9b7e4b2030452332f494e14f8d3
First added on: Dec 20, 2022