NCT06898099 Evaluation of the Efficacy of E2R Hypnotherapy in the Management of Chronic Insomnia in Primary Care (HypERR)

Eligibility & Interventions

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This trial targets 136 participants in total. It began in 2025-10-14 with a primary completion date of 2027-04-14.

Brief 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).

Eligibility Criteria

Inclusion Criteria: * Patient aged 18 or over, * Patient suffering from chronic insomnia according to the DSM-5 definition, whether or not treated with psychotropic drugs: \* At least one of the following sleep disorders: difficulty in falling asleep, difficulty in maintaining sleep, waking up too early and inability to go back to sleep, and \* At least 3 nights a week for at least 3 months, and \* In an adequate night-time sleep context, and \* With at least one significant impact on, or impairment of, social, occupational or behavioral functioning, and \* Insomnia not attributable to the physiological effects of a substance, and \* Insomnia not explicable by a medical condition or mental disorder. * 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, * Patient affiliated to the French social security system. Exclusion Criteria: * 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, * Patients unable to attend hypnotherapy consultations, * Deaf or hard-of-hearing patients without hearing aids, * Patient under legal protection (safeguard of justice, curatorship, guardianship) or deprived of liberty, * Women declaring themselves pregnant or breastfeeding.

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