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).
Patient aged 18 or over,
Patient willing to undergo hypnotherapy for 4 sessions of 30 min over 6 weeks,
Patient whose treating physician is the investigator,
Patient able to give free, informed, written consent,
Patients receiving or having received one or more hypnotherapy sessions (for any reason) in the last 5 years prior to inclusion,
Patient participating in another study involving the treatment of insomnia or another pathology having an impact on sleep disorders,
Patient unable to complete a self-administered questionnaire,
Patients with poor or no understanding of the French language,
Parallel
"Standard care" control group (without hypnosis)
Other interventionRandomization 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"
Other interventionRandomization 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.
Severity of Insomnia assessed by the Insomnia Severity Index (ISI)
Insomnia Severity Index (ISI). The minimum score is 0 meaning No Insomnia, the maximum is 28 meaning Severe clinical insomnia
Severity of Insomnia assessed by the Insomnia Severity Index (ISI)
Insomnia Severity Index (ISI). The minimum score is 0 meaning No Insomnia, the maximum is 28 meaning Severe clinical insomnia
Number of responders assessed by the Insomnia Severity index (ISI)
The responders are defined by a decrease \> 7 points on the ISI scale
Number of responders assessed by the Insomnia Severity index (ISI)
The responders are defined by a decrease \> 7 points on the ISI scale
Number of partial responders assessed by the Insomnia Severity index (ISI)
Partial responders are defined by a decrease between 4 and 7 points on the ISI scale)
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Rennes University Hospital
Lead sponsor
University of Rennes
Collaborator
