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

BACKGROUND: Hypnotherapy is an evidence-based therapy recommended for IBS, but access to therapist-led hypnotherapy is limited by costs and availability. OBJECTIVE: We studied the effectiveness of smartphone-based self-guided hypnotherapy versus in-person therapist-delivered hypnotherapy. DESIGN: 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. RESULTS: A total of 230 patients (mean±SD age 38.2±13.8 years, 70.4% female) were randomised. FDA abdominal pain response rates were 48% for in-person therapist-delivered hypnotherapy, 33% for smartphone-based self-guided hypnotherapy and 22% for psychoeducation. Non-inferiority of online to in-person hypnotherapy could not be shown (-14.7%, 95% CI -29.3% to 0.9%). In-person hypnotherapy was more effective than psychoeducation (OR 3.48, 95% CI 1.68 to 7.20, p<0.001) at week 16, both hypnotherapy groups were more effective at 6-month follow-up (OR 3.11, 95% CI 1.37 to 7.09, p=0.007 and OR 4.68, 95% CI 2.07 to 10.57, p<0.001). There were no significant treatment effects on psychological symptoms between groups. CONCLUSION: This multicentre RCT could not demonstrate non-inferiority of smartphone-based self-guided hypnotherapy compared with in-person therapist-delivered hypnotherapy in reducing abdominal pain. However, substantial response rates for smartphone-based self-guided hypnotherapy highlight its potential as a broadly applicable and cost-effective alternative. TRIAL REGISTRATION NUMBER: NCT03899779.