NCT03899779

Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome

Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome, According to a Non-inferiority Design. Three-armed Randomized Controlled Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 282 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Psychological therapies are effective in reducing irritable bowel syndrome (IBS) symptom severity and increasing quality of life and are recommended for the management of IBS by guidelines. Evidence appears strongest for the efficacy of hypnotherapy as psychological treatment. However, therapist-led interventions are time consuming and relatively costly. Approaches based on e-health are cost saving and appear more attractive to patients as no visits to a therapist are necessary. Therefore, the investigators plan to conduct a multicentre randomised controlled trial to examine whether the effectiveness of online hypnotherapy is non-inferior compared to individual face-to-face hypnotherapy delivered by a therapist, according to current FDA guidelines. Online psychoeducation will be used as control condition. In addition, the investigators hypothesize that treatment with online hypnotherapy is a more cost-effective therapy than face-to-face hypnotherapy in IBS patients.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
OTHER	Face-to-face hypnotherapy	12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)
OTHER	Online hypnotherapy	12 weeks treatment with online hypnotherapy
OTHER	Online psychoeducation	12 weeks treatment with online psychoeducation

Timeline

• Start date: 2019-07-08
• Primary completion: 2024-12-29
• Completion: 2025-06-29
• First posted: 2019-04-02
• Last updated: 2025-07-18

Locations

6 sites across 1 country: Netherlands