IBS - Irritable Bowel SyndromeNCT03432078
Individual vs. Group Hypnotherapy in Patients With Irritable Bowel Syndrome
A study testing Hypnotherapy in people with IBS - Irritable Bowel Syndrome, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Patients' fulfilling Rome III criteria for IBS with symptoms refractory to standard treatment who are referred to a specialist unit for hypnotherapy are consecutively included in the study. The patients are randomized to either individual or group treatment given by a nurse trained in hypnotherapy. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Hypnotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteSweden
- Study dates
- 15 Aug 2011to 31 Dec 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 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IBS according to Rome III criteria
Who cannot join
- Organic GI disease
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Internal Medicine, Sahlgrenska University Hospital
Gothenburg, 41345
About this study
Official title: Comparison of Effects Between Gut Directed Hypnotherapy Provided Either Individually or in a Group Setting for Patients With Irritable Bowel Syndrome (IBS) a Randomized Controlled Study.
Patients' fulfilling Rome III criteria for IBS with symptoms refractory to standard treatment who are referred to a specialist unit for hypnotherapy are consecutively included in the study. The patients are randomized to either individual or group treatment given by a nurse trained in hypnotherapy. The treatment consists of eight sessions of gut directed hypno therapy during twelve weeks. Effects are measured by validated questionnaires at baseline and at various time points during the treatment period as well as after the completion of the treatment.
Read the detailed description
Patients' fulfilling Rome III criteria for IBS with symptoms refractory to standard treatment who are referred to a specialist unit for hypnotherapy are consecutively included in the study. Firstly, the patients are invited to a meeting with the nurse for information about the study, check for eligibility and to sign the written informed consent. Exclusion criteria that could influence GI symptoms such as organic GI disease, severe psychiatric comorbidity and pregnancy are controlled for. The patients are randomized to either individual or group treatment given by a nurse trained in hypnotherapy and cognitive behavioral therapy. The randomization is organized and performed in blocks by an external unit connected to the University in order to be accurate. The treatment consists of eight sessions of gut directed hypnotherapy during twelve weeks. A standardized protocol is used and is the same both in the group setting as well as in the individual treatment arm. In each group approximately eight patients are included. Every session lasts for one hour. Outcome measures in the study are GI symptom severity, GI-specific anxiety, psychological distress and health related quality of life. These effects are measured by validated questionnaires at baseline and at various time points during the treatment period as well as after the completion of the treatment and during the 6 months-, 1 and 2 year follow-up.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- 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.
HypnotherapyOther
Non-pharmacological treatment
| Study group | Role | What they receive |
|---|---|---|
| Individual hypnotherapy | Active comparator | Treatment given on a individual basis, face to face. Receives: Other: Hypnotherapy |
| Group hypnotherapy | Active comparator | Treatment given in a group setting, face to face. Receives: Other: Hypnotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Gastrointestinal symptom severity
Measured with Irritable Bowel Syndrome- severity scoring system (IBS-SSS). The questionnaire measures severity of GI symptoms and consists of five questions where each score ranges from 0 to 100. A total score of all five questions is calculated ranging from 0 to 500. The higher the score the more severe the GI symptoms.
Measured: Up to ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start15 Aug 2011
- Primary completion31 Dec 2019
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432078
- Sponsor's protocol ID
- 686-11
- Status last verified
- Nov 2023
- First submitted
- 7 Feb 2018
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lovdahl J, Blomqvist-Storm M, Palsson OS, Ringstrom G, Tornblom H, Simren M, Trindade IA. Nurse-Administered Gut-Directed Hypnotherapy for Irritable Bowel Syndrome: A Two-Year Follow-Up Study. United European Gastroenterol J. 2025 Sep;13(7):1307-1317. doi: 10.1002/ueg2.70060. Epub 2025 Jun 9.
PubMed 40491242Lovdahl J, Tornblom H, Ringstrom G, Palsson OS, Simren M. Randomised clinical trial: individual versus group hypnotherapy for irritable bowel syndrome. Aliment Pharmacol Ther. 2022 Jun;55(12):1501-1511. doi: 10.1111/apt.16934. Epub 2022 May 3.
PubMed 35505463
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects Between Gut Directed Hypnotherapy Provided Either Individually or in a Group Setting for Patients With Irritable Bowel Syndrome (IBS) a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT03432078
- Acronym / sponsor ID
- 686-11
- Conditions
- IBS - Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 15 Aug 2011 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Feb 2018 (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.
Patients' fulfilling Rome III criteria for IBS with symptoms refractory to standard treatment who are referred to a specialist unit for hypnotherapy are consecutively included in the study. The patients are randomized to either individual or group treatment given by a nurse trained in hypnotherapy. The treatment consists of eight sessions of gut directed hypno therapy during twelve weeks. Effects are measured by validated questionnaires at baseline and at various time points during the treatment period as well as after the completion of the treatment.
Detailed description
Patients' fulfilling Rome III criteria for IBS with symptoms refractory to standard treatment who are referred to a specialist unit for hypnotherapy are consecutively included in the study. Firstly, the patients are invited to a meeting with the nurse for information about the study, check for eligibility and to sign the written informed consent. Exclusion criteria that could influence GI symptoms such as organic GI disease, severe psychiatric comorbidity and pregnancy are controlled for. The patients are randomized to either individual or group treatment given by a nurse trained in hypnotherapy and cognitive behavioral therapy. The randomization is organized and performed in blocks by an external unit connected to the University in order to be accurate. The treatment consists of eight sessions of gut directed hypnotherapy during twelve weeks. A standardized protocol is used and is the same both in the group setting as well as in the individual treatment arm. In each group approximately eight patients are included. Every session lasts for one hour. Outcome measures in the study are GI symptom severity, GI-specific anxiety, psychological distress and health related quality of life. These effects are measured by validated questionnaires at baseline and at various time points during the treatment period as well as after the completion of the treatment and during the 6 months-, 1 and 2 year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual hypnotherapy | Active comparator | Other: HypnotherapyTreatment given on a individual basis, face to face. |
| Group hypnotherapy | Active comparator | Other: HypnotherapyTreatment given in a group setting, face to face. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- IBS according to Rome III criteria
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 |
|---|---|---|
| HypnotherapyNon-pharmacological treatment | Other | Group hypnotherapy, Individual hypnotherapy |
Primary outcome
Change of Gastrointestinal symptom severity
Time frame: Up to ten years
Measured with Irritable Bowel Syndrome- severity scoring system (IBS-SSS). The questionnaire measures severity of GI symptoms and consists of five questions where each score ranges from 0 to 100. A total score of all five questions is calculated ranging from 0 to 500. The higher the score the more severe the GI symptoms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Derived from this study: PubMed 40491242Lovdahl J, Blomqvist-Storm M, Palsson OS, Ringstrom G, Tornblom H, Simren M, Trindade IA. Nurse-Administered Gut-Directed Hypnotherapy for Irritable Bowel Syndrome: A Two-Year Follow-Up Study. United European Gastroenterol J. 2025 Sep;13(7):1307-1317. doi: 10.1002/ueg2.70060. Epub 2025 Jun 9.
- Derived from this study: PubMed 35505463Lovdahl J, Tornblom H, Ringstrom G, Palsson OS, Simren M. Randomised clinical trial: individual versus group hypnotherapy for irritable bowel syndrome. Aliment Pharmacol Ther. 2022 Jun;55(12):1501-1511. doi: 10.1111/apt.16934. Epub 2022 May 3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotherapy in people with IBS - Irritable Bowel Syndrome, run by Sahlgrenska University Hospital at 1 site 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: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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 of Gastrointestinal symptom severity (time frame: Up to ten years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03432078, which also lists 2 linked publications.
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 7 Dec 2023.