Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Contribution of a Non Medicamentous Approach by Hypnosis on Quality of Life in Crohn Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Drug: immunosuppressor/TNFalpha
* Behavioral: Hypnosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Person under legal protection (articles L1121-5 and L1121-8 of Public health code) Person in exclusion period of another study Hypnosis contraindication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective study, monocentric, controlled, randomized, open-label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: immunosuppressor/TNFalpha<br>Standard treatment with immunosuppressor and/or anti-TNFalpha treatment. | Drug: immunosuppressor/TNFalpha<br>* Standard Treatment : immunosuppressor/TNFalpha as in standard practice<br>|
| Experimental: Hypnosis + Standard Treatment<br>Standard treatment with immunosuppressor and/or anti-TNFalpha treatment in addition to hypnosis parallel treatment. | Behavioral: Hypnosis<br>* 8 hypnosis group sessions during 2 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | 3 months and 6 months | 
| Vagal tonus with electrocardiogram | Evolution of the vagal tonus with electrocardiogram short and mid term | 3 months and 6 months | 
| Inflammatory status with C Reactive Protein | Evolution of the C Reactive Protein concentration in the plasma | 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. | 3 months and 6 months | 
| Fatigue with Multidimensional Fatigue Inventory | Evolution of fatigue status short and mid term | 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. | 12 months | 
| Clinical score with Harvey-Bradshaw Index long term | Evolution of the clinical score long term with Harvey-Bradshaw Index | 12 months |