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Evaluation of the Efficacy of E2R Hypnotherapy in the Management of Chronic Insomnia in Primary Care (HypERR)
Sponsor: Rennes University Hospital
Summary
In France, the treatment of chronic insomnia relies mainly on hypnotic drugs in routine care, despite the high level of iatrogenicity. Cognitive-behavioral therapy (CBT) is recommended by the HAS as a non-pharmaceutical first-line therapy for chronic insomnia. Despite evidence of their efficacy in chronic insomnia, these therapies remain underdeveloped in France (few practitioners, time-consuming for the patient). Hypnotherapy is another non-drug intervention suitable for routine outpatient care. Among the hypnosis methods practiced in France, E2R (Emotion, Regression, Repair) is a hypnotherapy method used in general practice, particularly for chronic insomnia. To date, no clinical trials have been carried out to demonstrate its effectiveness in this pathology. The HypERR study is a multicenter, randomized, open-label study designed to evaluate the efficacy of a hypotherapy method called E2R in the management of chronic insomnia, by comparing it with standard care (without hypnosis).
Official title: Evaluation of the Efficacy of E2R Hypnotherapy in the Management of Chronic Insomnia in Primary Care
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
136
Start Date
2025-10-14
Completion Date
2027-04-14
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
"Standard care" control group (without hypnosis)
Randomization stratification on insomnia severity. In the "Standard care" group, the investigating physician will not change his or her current practice as part of the study. Treatment will be the same as usual, whether drug-based or not (psychotherapy, etc.), with the exception of hypnosis. The patients will be reviewed at 3 months and 6 months (+/- 1 week) after randomization (D0). The following study information and questionnaires will be completed according to patients' responses: ISI and PSQI self-questionnaires, Record of psychotropic medications, Record of any non-drug therapies implemented, Events that could modify sleep, Serious adverse events (EvIG) and non-serious adverse events (EvING) of a neuropsychiatric nature that occurred or worsened during the study.
Experimental group: "E2R hypnosis"
Randomization stratification on insomnia severity. For the patients randomized to the Hypnosis E2R arm, patients summoned within 15 days to 3 weeks of inclusion for their first hypnotherapy session with the hypnotherapist. All patients will receive 4 hypnotherapy sessions over 6 weeks using the E2R method. The patients will be reviewed at 3 months and 6 months (+/- 1 week) after randomization (D0). The following study information and questionnaires will be completed according to patients' responses: ISI and PSQI self-questionnaires, Record of psychotropic medications, Record of any non-drug therapies implemented, Practice of self-hypnosis requested of the patient (patient diary), Events that could modify sleep, Serious adverse events (EvIG) and non-serious adverse events (EvING) of a neuropsychiatric nature that occurred or worsened during the study.
Locations (35)
Cabinet médical
Bain-de-Bretagne, France
Cabinet médical de Plaisance
Bouaye, France
Cabinet médical de Plaisance
Bouaye, France
Cabinet médical de Breteil
Breteil, France
Cabinet médical
Cesson-Sévigné, France
Cabinet médical du Linon
Combourg, France
Cabinet médical Sycamore
Contres, France
Cabinet médical de Corps Nuds
Corps-Nuds, France
Cabinet médical des Embruns
Crac'h, France
Pôle Santé Physiomast
Dol-de-Bretagne, France
MSP de l'Esplanade
Guer, France
Maison médicale
Iffendic, France
Cabinet Médical Chantepie
Joué Les Tours, France
Cabinet Médical de Jugon-Les-Lacs -Saint-Igneuc
Jugon-les-Lacs, France
Maison médicale des Longrais
La Chapelle-des-Fougeretz, France
Cabinet médical
La Chapelle-Saint-Ursin, France
Cabinet médical du Lion d'Or
Nantes, France
Maison médicale Laennec
Pleudihen-sur-Rance, France
Maison De Santé De Ronsouze
Ploërmel, France
Cabinet médical Les Petits Ponts
Pont-Saint-Martin, France
Cabinet médical Les Petits Ponts
Pont-Saint-Martin, France
Maison de Santé de Questembert
Questembert, France
Cabinet médical Olec
Rennes, France
Cabinet médical
Rennes, France
Maison médicale pluridisciplinaire
Rouziers-de-Touraine, France
Maison médical de Maen roch
Saint-Brice-en-Coglès, France
Maison médicale
Saint-Gilles-Croix-de-Vie, France
Maison médicale
Saint-Gilles-Croix-de-Vie, France
Maison de soin du Couesnon
Saint-Ouen-des-Alleux, France
Cabinet médical
Saint-Romain-sur-Cher, France
Maison de santé
Sancerre, France
Cabinet médical de la Blanchisserie
Sully-sur-Loire, France
Maison de santé
Talensac, France
Cabinet des médecins généralistes de TIGY
Tigy, France
Cabinet médical
Vildé-Guingalan, France