IBS - Irritable Bowel SyndromeNCT06297785
Online, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS)
A study testing Gut-directed hypnotherapy in people with IBS - Irritable Bowel Syndrome, run by Sahlgrenska University Hospital at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Gut-directed hypnotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSweden
- Study dates
- 17 Oct 2022to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IBS diagnosis
Who cannot join
- Organic GI disease
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Mag-Tarmlab, Sahlgrenska University Hospital
Gothenburg, 41345
Sahlgrenska University Hospital
Gothenburg, 41345
About this study
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.
Read the detailed description
IBS patients with symptoms refractory to standard treatment and who were referred to a specialist unit for hypnotherapy, will be included in the study consecutively. The patients will receive gut-directed hypnotherapy given by a nurse trained in Cognitive Behavioral Therapy (CBT) and hypnotherapy. Effects of treatment will be measured by validated questionnaires at baseline and at various time points during the treatment period, as well as after the completion of the treatment at follow-up 6 months, 1 and 2 years after treatment.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Gut-directed hypnotherapy
- Keywords
- Gut-directed hypnotherapy
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gut-directed hypnotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-delivered, gut-directed hypnotherapy | Other | Not described Receives: Behavioral: Gut-directed hypnotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (week 0), during treatment (week 6), at treatment completion (week 12), follow-up (6 months, 1 and 2 years after treatment initiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start17 Oct 2022
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Simrén, Sahlgrenska University Hospital
- Investigators
- Magnus Simrén, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297785
- Sponsor's protocol ID
- 2022-03997-01
- Status last verified
- Jan 2026
- First submitted
- 1 Mar 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT06297785
- Acronym / sponsor ID
- 2022-03997-01
- Conditions
- IBS - Irritable Bowel Syndrome
- Keywords
- Gut-directed hypnotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
IBS patients with symptoms refractory to standard treatment and who were referred to a specialist unit for hypnotherapy, will be included in the study consecutively. The patients will receive gut-directed hypnotherapy given by a nurse trained in Cognitive Behavioral Therapy (CBT) and hypnotherapy. Effects of treatment will be measured by validated questionnaires at baseline and at various time points during the treatment period, as well as after the completion of the treatment at follow-up 6 months, 1 and 2 years after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nurse-delivered, gut-directed hypnotherapy | Other | Behavioral: Gut-directed hypnotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- IBS diagnosis
Key exclusion criteria (1 listed)
- Organic GI disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gut-directed hypnotherapyGut-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. | Behavioural | Nurse-delivered, gut-directed hypnotherapy |
Primary outcome
Change in gastrointestinal symptom severity measured by the IBS Severity Scoring System questionnaire (IBS-SSS)
Time frame: Baseline (week 0), during treatment (week 6), at treatment completion (week 12), follow-up (6 months, 1 and 2 years after treatment initiation)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Simrén principal investigator
Göteborg University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gut-directed hypnotherapy in people with IBS - Irritable Bowel Syndrome, run by Sahlgrenska University Hospital at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gastrointestinal symptom severity measured by the IBS Severity Scoring System questionnaire (IBS-SSS) (time frame: Baseline (week 0), during treatment (week 6), at treatment completion (week 12), follow-up (6 months, 1 and 2 years after treatment initiation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.