Crohn DiseaseHYPNOCROHNNCT03623932
Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease
A study testing immunosuppressor/TNFalpha and Hypnosis in people with Crohn Disease, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Evaluation of hypnosis therapy efficacy in addition to pharmacologic standard treatment of Croh disease during remission by the evaluation of quality of life; Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- immunosuppressor/TNFalpha and Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2018to 13 Nov 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with ileal or colic Crohn disease
- stable treatment for Crohn disease
- clinical and biologic remission (normal C reactive protein and fecal calprotectin < 100 µg/g)
- patient living in Grenoble area
- informed consent form
- social security affiliation
Who cannot join
- Person under legal protection (articles L1121-5 and L1121-8 of Public health code)
- Person in exclusion period of another study
- Hypnosis contraindication
Trial locations and contacts
1 site in 1 country.
Nicolas GONNET contact
France1 site, 1 recruiting
- Recruiting
University Hospital
Grenoble, 38000
Bruno BONAZ, BBonaz@chu-grenoble.fr
About this study
Evaluation of hypnosis therapy efficacy in addition to pharmacologic standard treatment of Croh disease during remission by the evaluation of quality of life;
Read the detailed description
Crohn disease is defined as an inflammatory chronic disease of the bowel characterize by intermittent flare-ups and remission periods.
Crohn disease is due to genetic and environmental factors such as stress. Stress is an important aggravation factor of the disease symptoms which can stop a remission period and induce a relapse into a flare-up period.
Hypnosis is a non-medicinal technic which already show efficacy in the treatment of functional digestive troubles. These diseases are bio/psycho/social models such as Crohn disease.
Hypnosis can reduce visceral pain sensibility, reduce stress and reduce pro-inflammatory cytokines liberation into intestinal mucosa.
Though, only few data are available on hypnosis interest in the treatment of Crohn disease and inflammatory bowel diseases as it is often isolated clinical case report.
One study on patients with rectocolitis in remission period has been done recently and show that hypnosis increased the duration of the remission period.
The principal objective of this study is to evaluate hypnosis efficacy in term of quality of life for patients with Crohn disease during remission.
- Conditions
- Crohn Disease
- Being tested
- immunosuppressor/TNFalpha, Hypnosis
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunosuppressor/TNFalphaDrug
Standard Treatment : immunosuppressor/TNFalpha as in standard practice
HypnosisBehavioural
8 hypnosis group sessions during 2 months
| Study group | Role | What they receive |
|---|---|---|
| immunosuppressor/TNFalpha | Active comparator | Standard treatment with immunosuppressor and/or anti-TNFalpha treatment. Receives: Drug: immunosuppressor/TNFalpha |
| Hypnosis + Standard Treatment | Experimental | Standard treatment with immunosuppressor and/or anti-TNFalpha treatment in addition to hypnosis parallel treatment. Receives: Behavioral: Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mid term hypnosis efficacy with IBDQ
Efficacy evaluation of hypnosis 6 months after the beginning of hypnosis sessions on the quality of life with Inflammatory Bowel Disease Questionnaire (IBDQ)
Measured: 6 months
Secondary outcomes (9)
Short term hypnosis efficacy with IBDQ
Efficacy evaluation of hypnosis 3 months after the beginning of hypnosis sessions on the quality of life with Inflammatory Bowel Disease Questionnaire (IBDQ)
Measured: 3 months
Disease acceptance with ICQ-18
Impact of hypnosis on the disease acceptance short and mid term with the Evolution of the Illness Cognition Questionnaire for chronic disease
Measured: 3 months and 6 months
Clinical score with Harvey-Bradshaw Index short and mid term
Evolution of the clinical score short and mid term with Harvey-Bradshaw Index
Measured: 3 months and 6 months
Vagal tonus with electrocardiogram
Evolution of the vagal tonus with electrocardiogram short and mid term
Measured: 3 months and 6 months
Inflammatory status with C Reactive Protein
Evolution of the C Reactive Protein concentration in the plasma
Measured: 3 months and 6 months
Stress with Perceived Stress Scale
Evolution of stress status short and mid term with Perceived Stress Scale which goes from 10 to 50. Lower values represent better outcome.
Measured: 3 months and 6 months
Fatigue with Multidimensional Fatigue Inventory
Evolution of fatigue status short and mid term
Measured: 3 months and 6 months
Long term hypnosis efficacy
Efficacy evaluation of hypnosis 12 months after the beginning of hypnosis sessions on the quality of life with Inflammatory Bowel Disease Questionnaire (IBDQ) which goes from 32 to 224. Higher values represent better outcome.
Measured: 12 months
Clinical score with Harvey-Bradshaw Index long term
Evolution of the clinical score long term with Harvey-Bradshaw Index
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start13 Nov 2018
- Primary completion12 Nov 2021 (estimated)
- Study completion13 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective study, monocentric, controlled, randomized, open-label
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623932
- Sponsor's protocol ID
- 38RC17.298
- Acronym
- HYPNOCROHN
- Status last verified
- Mar 2020
- First submitted
- 4 Jul 2018
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease
- ClinicalTrials.gov ID
- NCT03623932
- Acronym / sponsor ID
- HYPNOCROHN / 38RC17.298
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 12 Nov 2021 (estimated)
- Study completion
- 13 Nov 2021 (estimated)
- First posted
- 9 Aug 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.
Evaluation of hypnosis therapy efficacy in addition to pharmacologic standard treatment of Croh disease during remission by the evaluation of quality of life;
Detailed description
Crohn disease is defined as an inflammatory chronic disease of the bowel characterize by intermittent flare-ups and remission periods.
Crohn disease is due to genetic and environmental factors such as stress. Stress is an important aggravation factor of the disease symptoms which can stop a remission period and induce a relapse into a flare-up period.
Hypnosis is a non-medicinal technic which already show efficacy in the treatment of functional digestive troubles. These diseases are bio/psycho/social models such as Crohn disease.
Hypnosis can reduce visceral pain sensibility, reduce stress and reduce pro-inflammatory cytokines liberation into intestinal mucosa.
Though, only few data are available on hypnosis interest in the treatment of Crohn disease and inflammatory bowel diseases as it is often isolated clinical case report.
One study on patients with rectocolitis in remission period has been done recently and show that hypnosis increased the duration of the remission period.
The principal objective of this study is to evaluate hypnosis efficacy in term of quality of life for patients with Crohn disease during remission.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective study, monocentric, controlled, randomized, open-label
| Arm | Type | Receives |
|---|---|---|
| immunosuppressor/TNFalpha | Active comparator | Drug: immunosuppressor/TNFalphaStandard treatment with immunosuppressor and/or anti-TNFalpha treatment. |
| Hypnosis + Standard Treatment | Experimental | Behavioral: HypnosisStandard treatment with immunosuppressor and/or anti-TNFalpha treatment in addition to hypnosis parallel treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patient with ileal or colic Crohn disease
- stable treatment for Crohn disease
- clinical and biologic remission (normal C reactive protein and fecal calprotectin < 100 µg/g)
- patient living in Grenoble area
- informed consent form
Key exclusion criteria (3 listed)
- Person under legal protection (articles L1121-5 and L1121-8 of Public health code)
- Person in exclusion period of another study
- Hypnosis contraindication
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 |
|---|---|---|
| immunosuppressor/TNFalphaStandard Treatment : immunosuppressor/TNFalpha as in standard practice | Drug | immunosuppressor/TNFalpha |
| Hypnosis8 hypnosis group sessions during 2 months | Behavioural | Hypnosis + Standard Treatment |
Primary outcome
Mid term hypnosis efficacy with IBDQ
Time frame: 6 months
Efficacy evaluation of hypnosis 6 months after the beginning of hypnosis sessions on the quality of life with Inflammatory Bowel Disease Questionnaire (IBDQ)
9 secondary outcomes
Short term hypnosis efficacy with IBDQ
Time frame: 3 months
Disease acceptance with ICQ-18
Time frame: 3 months and 6 months
Clinical score with Harvey-Bradshaw Index short and mid term
Time frame: 3 months and 6 months
Vagal tonus with electrocardiogram
Time frame: 3 months and 6 months
Inflammatory status with C Reactive Protein
Time frame: 3 months and 6 months
Stress with Perceived Stress Scale
Time frame: 3 months and 6 months
Fatigue with Multidimensional Fatigue Inventory
Time frame: 3 months and 6 months
Long term hypnosis efficacy
Time frame: 12 months
Clinical score with Harvey-Bradshaw Index long term
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Derived from this study: PubMed 40243391Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
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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.
Nicolas GONNET contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immunosuppressor/TNFalpha and Hypnosis in people with Crohn Disease, run by University Hospital, Grenoble at 1 site in France.
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 6 inclusion and 3 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 23 Mar 2020. 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 France. 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?
Contact Bruno BONAZ, PU-PH (04 76 76 55 97, BBonaz@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mid term hypnosis efficacy with IBDQ (time frame: 6 months). 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 NCT03623932, which also lists 1 linked publication.
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 23 Mar 2020.