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

NCT03899779 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2025-07-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Daniel Keszthelyi, MD, PhD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-08
Primary Completion
2024-12-29
Completion
2025-06-29

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03899779 on ClinicalTrials.gov