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

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT03899779
• Lead Sponsor: Maastricht University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-02
• Study Start: 2019-07-08
• Primary Completion: 2024-12-29
• Study Completion: 2025-06-29
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Abdominal pain response rate after 12 weeks of treatment	12 weeks	A responder is defined as a patient who experiences at least a 30 percent decrease in the weekly average of worst daily abdominal pain (measured daily, on an 11 point NRS) compared to baseline weekly average in at least 50 percent of the weeks in which the treatment in given.

Secondary Outcome Measures

Name	Time	Method
Indirect costs	16 weeks and after 6 months and 1 year follow-up	determined by Productivity Cost Questionnaire (PCQ) (savings from increased work productivity)
General Quality of life (by EQ-5D)	16 weeks and after 6 months and 1 year follow-up	Determined by the Euro-Quality of Life - 5 domains (EQ-5D-5L) (change from baseline)
Use of over the counter medication and rescue medication	12 and 16 weeks	As reported via digital diary (mobile phone application)
Response rates in relation to comorbid depression	16 weeks and after 6 months and 1 year follow-up	Assessed with the use of the Patient Health Questionnaire-9 (PHQ-9). \[PHQ-9 minimum score: 0, maximum score: 21\]
Improvement of symptom severity	16 weeks	determined by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) by 50 points or more \[IBS-SSS, minimum score 0, maximum score 500\]
Expectation	16 weeks	Response rates in relation to patient expectation prior to the start of treatment
Response rates in relation to comorbid anxiety	16 weeks and after 6 months and 1 year follow-up	Assessed with the use of the Generalized Anxiety Disorder-7 (GAD-7). \[GAD-7 minimum score: 0, maximum score: 21\]
Degree of relief response rate after 12 weeks of treatment	12 weeks	A responder is defined as a patient who experiences a weekly relief of 1 or 2 (on a 7 point NRS) in at least 50 percent of the weeks in which treatment is given.
IBS related Quality of life (by IBS-QoL)	16 weeks and after 6 months and 1 year follow-up	Determined by IBS Quality of Life (IBS-QoL) (change from baseline) \[IBS-QoL, minimum score: 0, maximum score 100\]
Number and severity of side effects	12 and 16 weeks	As reported via digital diary (mobile phone application)
Direct costs	16 weeks and after 6 months and 1 year follow-up	determined by Medical Consumption Questionnaire (MCQ) (savings from reduced medical resource use)

Trial Locations

Locations (6)

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Friesland, Netherlands

Gelderse Vallei; 🇳🇱 Ede, Gelderland, Netherlands

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands

Jeroen Bosch Ziekenhuis; 🇳🇱 Den Bosch, Noord-Brabant, Netherlands

Bernhoven; 🇳🇱 Uden, Noord-Brabant, Netherlands

Martini Ziekenhuis; 🇳🇱 Groningen, Netherlands