Online, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS)
1 other identifier
interventional
50
1 country
2
Brief Summary
Adult IBS patients with symptoms refractory to standard medical treatment will receive online nurse-administered, gut-directed hypnotherapy in groups. The primary outcome measure was change in gastro-intestinal symptom severity. Secondary outcomes are GI-specific anxiety, general anxiety and depression, quality of life, and extracolonic symptom severity. Usability of the digital platform as well as patient treatment satisfaction will also be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 17, 2022
CompletedFirst Submitted
Initial submission to the registry
March 1, 2024
CompletedFirst Posted
Study publicly available on registry
March 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedJanuary 12, 2026
January 1, 2026
2.6 years
March 1, 2024
January 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in gastrointestinal symptom severity measured by the IBS Severity Scoring System questionnaire (IBS-SSS)
The score is calculated from 5 items: pain severity, pain frequency, abdominal bloating severity, bowel habit dissatisfaction and daily life interference. The score ranges from 0-500. A higher the score signifies more severe symptoms. A symptom score reduction of 50 points or more after treatment compared to the baseline score is considered a response to treatment.
Baseline (week 0), during treatment (week 6), at treatment completion (week 12), follow-up (6 months, 1 and 2 years after treatment initiation)
Study Arms (1)
Nurse-delivered, gut-directed hypnotherapy
OTHERInterventions
Gut-directed hypnotherapy for patients with irritable bowel syndrome (IBS). Gut-directed hypnotherapy (8 sessions), will be given online in a group setting.The hypnosis treatment is administered by a nurse specially trained in Cognitive Behavioral Therapy (CBT) and hypnotherapy. The treatment is based on the North Carolina protocol. Patients will assess gastro-intestinal symptom severity before, during and after treatment, as well as at follow-up.
Eligibility Criteria
You may qualify if:
- IBS diagnosis
You may not qualify if:
- Organic GI disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Mag-Tarmlab, Sahlgrenska University Hospital
Gothenburg, 41345, Sweden
Sahlgrenska University Hospital
Gothenburg, 41345, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magnus Simrén
Göteborg University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD
Study Record Dates
First Submitted
March 1, 2024
First Posted
March 7, 2024
Study Start
October 17, 2022
Primary Completion
May 30, 2025
Study Completion
May 30, 2025
Last Updated
January 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share