In-person therapist-delivered hypnotherapy versus smartphone-based self-guided hypnotherapy in IBS: a multicentre three-armed randomised controlled trial (GUT)

This multicentre, three-armed non-inferiority randomised controlled trial (RCT) included patients with IBS (Rome IV, 16–75 years). Patients were randomised to 12-week in-person therapist-delivered hypnotherapy, smartphone-based self-guided hypnotherapy or online self-guided psychoeducation. The primary endpoint was abdominal pain response per Food and Drug Administration (FDA) definition (≥30% reduction from baseline in weekly average of worst daily abdominal pain in at least 2 out of 4 weeks follow-up). The non-inferiority margin was 10%. Secondary endpoints included ≥50 points IBS-symptom severity scale reduction and changes in psychological symptoms.