Can a smartphone app replace in-person hypnotherapy for IBS? Trial finds non-inferiority not demonstrated, but response rates suggest a viable alternative

A recently published randomised controlled trial (RCT) comparing in-person therapist-delivered hypnotherapy with a smartphone-based self-guided hypnotherapy app for irritable bowel syndrome (IBS) has failed to demonstrate non-inferiority for the primary endpoint of abdominal pain response. Despite this, the smartphone intervention achieved substantial response rates and remained superior to a psychoeducation control group at longer follow-up, suggesting it could expand access to evidence-based therapy.

Key Points

• In-person hypnotherapy met FDA abdominal pain response (≥30% reduction) in 48% of patients, smartphone self-guided hypnotherapy in 33%, and psychoeducation in 22%.

• Non-inferiority of the smartphone app to in-person therapy was not shown (absolute difference −14.7%, 95% CI −29.3% to 0.9%; margin 10%).

• Both hypnotherapy groups were superior to psychoeducation at 6-month follow-up (OR 3.11 and 4.68, p<0.01).

• No significant between-group differences in psychological symptom changes were observed.

Background: Expanding access to an evidence-based IBS therapy

Hypnotherapy is recommended in several IBS guidelines as a treatment for abdominal pain and bowel symptoms, but access remains limited. Most practitioners are concentrated in specialised centres, and insurance coverage is inconsistent. A smartphone-delivered self-guided hypnotherapy program could overcome these barriers, provided its efficacy is comparable to the traditional therapist-led format.

To test this, a Dutch multicentre team enrolled 230 adults meeting Rome IV criteria for IBS (mean age 38.2 years, 70.4% female) at six centres. Participants were randomised in a 1:1:1 ratio to 12 weeks of in-person therapist-delivered hypnotherapy (n=78), smartphone-based self-guided hypnotherapy (n=76), or online self-guided psychoeducation (n=76).

Study design: A non-inferiority framework

The trial used a non-inferiority design with a margin of 10% absolute difference for the primary endpoint: the proportion of patients achieving at least a 30% reduction from baseline in the weekly average of worst daily abdominal pain for at least 2 out of 4 weeks of follow-up (the US Food and Drug Administration (FDA) responder definition). Randomisation was stratified by study centre, and the analysis followed a modified intention-to-treat approach. The secondary endpoint included a ≥50-point reduction on the IBS-Symptom Severity Scale (IBS-SSS) and changes in psychological symptoms (anxiety, depression, somatisation).

Primary outcome: Non-inferiority not met

The FDA abdominal pain response rate was 48% (37/77 evaluable) in the in-person therapy arm, 33% (25/76) in the smartphone-app arm, and 22% (16/74) in the psychoeducation arm. The absolute difference between the two hypnotherapy groups was −14.7 percentage points (95% CI −29.3% to 0.9%), which crossed the predefined non-inferiority margin of 10%. In other words, the smartphone app could not be considered non-inferior to in-person therapy based on this primary endpoint.

Figure 2　(A–B) Percentage of patients who were abdominal pain responder in the ITT population (n=230). An abdominal pain responder was defined as a patient with at least 30% decrease in main worst daily abdominal pain in at least 50% of the weeks (A) in week 13–16 and (B) follow-up week 35–38. FDA, Food and Drug Administration; ITT, intention-to-treat.

Figure 3　IBS-SSS in the ITT population (n=230). Values represent observed means.

However, in-person hypnotherapy was significantly more effective than psychoeducation at week 16 (odds ratio 3.48, 95% CI 1.68 to 7.20, p<0.001), confirming the internal validity of the trial.

Secondary outcomes: Hypnotherapy arms show sustained benefit

At the 6-month follow-up, the picture changed. Both the in-person hypnotherapy (OR 3.11, 95% CI 1.37 to 7.09, p=0.007) and the smartphone self-guided hypnotherapy (OR 4.68, 95% CI 2.07 to 10.57, p<0.001) retained a statistically significant advantage over psychoeducation. This suggests that the smartphone-based intervention may have a delayed or cumulative effect that persists after the treatment period.

Regarding the IBS-SSS secondary endpoint, response rates (≥50-point reduction) were numerically higher in the hypnotherapy arms, but the abstract did not provide formal between-group statistical comparisons for this outcome at the primary endpoint. No significant differences in psychological symptom scales (anxiety, depression, somatisation) were detected between the three treatment arms.

Interpretation: Not non-inferior, but pragmatic potential remains

The failure to establish non-inferiority for the smartphone app relative to in-person therapy does not mean the digital tool is ineffective. Its 33% responder rate is clinically meaningful, especially given the low burden and wide accessibility of a self-managed program. The magnitude of benefit at 6 months suggests that participants may continue to improve or maintain gains after the active intervention phase.

Because the trial was open-label (patients and therapists knew the treatment allocation), the possibility of differential expectations or placebo effects cannot be excluded. However, the superiority of both hypnotherapy arms over psychoeducation supports a specific treatment effect beyond general attention or information.

Limitations

This RCT has several limitations. The non-inferiority margin of 10% absolute difference is generous, but the confidence interval overlapped zero at the upper bound, meaning that the smartphone app could be slightly inferior or equivalent. The sample size (n=230) is modest, and subgroup or safety analyses were not reported in this abstract. The primary analysis was modified intention-to-treat; per-protocol results might differ. The lack of blinding is inherent to behavioural interventions but introduces bias risk. Finally, the study did not correct for multiplicity in secondary endpoints, so the long-term superiority findings should be considered exploratory.

Funding and registration

The trial was supported by a grant from the Dutch Research Council (NWO) and co-funded by several academic hospitals. The clinical trial is registered at ClinicalTrials.gov with identifier NCT03899779.

Study Snapshot: In-person vs. smartphone hypnotherapy for IBS

• Design: Multicentre, three-arm, non-inferiority randomised controlled trial (1:1:1).

• Population: 230 adults with Rome IV IBS, aged 16–75 years (mean 38.2 years; 70.4% female).

• Interventions: 12 weeks of in-person therapist-delivered hypnotherapy; smartphone-based self-guided hypnotherapy (app); online self-guided psychoeducation.

• Primary endpoint: FDA abdominal pain response (≥30% reduction in weekly average worst pain for ≥2 of 4 weeks). Non-inferiority margin: 10% absolute difference.

• Primary result: In-person 48%, smartphone 33%, psychoeducation 22%. Absolute difference (smartphone vs. in-person): −14.7% (95% CI −29.3% to 0.9%). Non-inferiority not met.

• Secondary results (6-month follow-up): Both hypnotherapy groups superior to psychoeducation (OR 3.11 and 4.68, p<0.007). No significant psychological symptom differences.

• Safety: Not reported in the abstract.

• Funding: Dutch Research Council and academic hospitals. ClinicalTrials.gov: NCT03899779.

References

1. Snijkers JTW, Bosman MHMA, Winkens B, et al. In-person therapist-delivered hypnotherapy versus smartphone-based self-guided hypnotherapy in IBS: a multicentre three-armed randomised controlled trial. Gut. 2026. DOI: 10.1136/gutjnl-2025-338921. PMID: 42502003.