In-person therapist-delivered hypnotherapy versus smartphone-based self-guided hypnotherapy in IBS: a multicentre three-armed randomised controlled trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: 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.
Source: Gut
Institutions: Maastricht University Medical Centre, Maastricht University, Care and Public Health Research Institute, Ziekenhuis Bernhoven, Ziekenhuis Gelderse Vallei, Jeroen Bosch Ziekenhuis, Frisius MC, Martini Ziekenhuis, Erasmus University Rotterdam, Leiden University Medical Center, University Medical Center Utrecht
Language: English
Subfield: Gastroenterology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Funder: ZonMw
Award: G7149980552
OpenAlex ID: W7171106034
