E2R hypnotherapy for chronic insomnia in primary care
Evaluation of the Efficacy of E2R Hypnotherapy in the Management of Chronic Insomnia in Primary Care
This study will try whether four short E2R hypnotherapy sessions help adults with chronic insomnia sleep better compared with usual care in general practice.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rennes University Hospital Academic / other |
| Locations | 35 sites (Bain-de-Bretagne and 34 other locations) |
| Trial ID | NCT06898099 on ClinicalTrials.gov |
What this trial studies
HypERR is a multicenter, randomized, open-label trial run through participating general practitioners who randomize patients to either E2R hypnotherapy or standard care without hypnosis. Patients assigned to E2R are referred to a local hypnotherapist and receive four 30-minute sessions delivered over six weeks, while control patients receive usual GP-led care which may include psychotherapy or medication but not hypnosis. Outcomes are collected by the GP at baseline, 3 months, and 6 months after randomization to track changes in insomnia symptoms and related functioning. The trial is embedded in routine primary care across multiple GP practices in France to reflect real-world delivery.
Who should consider this trial
Good fit: Adults (18+) meeting DSM-5 criteria for chronic insomnia who can attend four 30-minute hypnotherapy sessions, are patients of a participating GP, and are covered by the French social security system.
Not a fit: Patients whose insomnia is attributable to substances, another medical or primary psychiatric disorder, those unwilling to try hypnosis, or those unable to attend local hypnotherapy sessions are less likely to benefit from this intervention.
Why it matters
Potential benefit: If successful, E2R hypnotherapy could reduce insomnia symptoms and lower reliance on sleep medications for patients seen in primary care.
How similar studies have performed: While hypnotherapy and CBT approaches have shown benefit for insomnia generally, no randomized clinical trials have specifically tested the E2R hypnotherapy method for chronic insomnia to date.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bain-de-Bretagne and 34 other locations
- Cabinet médical — Bain-de-Bretagne, France (Recruiting)
- Cabinet médical de Plaisance — Bouaye, France (Recruiting)
- Cabinet médical de Plaisance — Bouaye, France (Recruiting)
- Cabinet médical de Breteil — Breteil, France (Recruiting)
- Cabinet médical — Cesson-Sévigné, France (Recruiting)
- Cabinet médical du Linon — Combourg, France (Recruiting)
- Cabinet médical Sycamore — Contres, France (Withdrawn)
- Cabinet médical de Corps Nuds — Corps-Nuds, France (Not_yet_recruiting)
- Cabinet médical des Embruns — Crac'h, France (Recruiting)
- Pôle Santé Physiomast — Dol-de-Bretagne, France (Recruiting)
- MSP de l'Esplanade — Guer, France (Recruiting)
- Maison médicale — Iffendic, France (Recruiting)
- Cabinet Médical Chantepie — Joué Les Tours, France (Recruiting)
- Cabinet Médical de Jugon-Les-Lacs -Saint-Igneuc — Jugon-les-Lacs, France (Recruiting)
- Maison médicale des Longrais — La Chapelle-des-Fougeretz, France (Recruiting)
- Cabinet médical — La Chapelle-Saint-Ursin, France (Recruiting)
- Cabinet médical du Lion d'Or — Nantes, France (Recruiting)
- Maison médicale Laennec — Pleudihen-sur-Rance, France (Recruiting)
- Maison De Santé De Ronsouze — Ploërmel, France (Recruiting)
- Cabinet médical Les Petits Ponts — Pont-Saint-Martin, France (Recruiting)
- Cabinet médical Les Petits Ponts — Pont-Saint-Martin, France (Recruiting)
- Maison de Santé de Questembert — Questembert, France (Recruiting)
- Cabinet médical Olec — Rennes, France (Recruiting)
- Cabinet médical — Rennes, France (Recruiting)
- Maison médicale pluridisciplinaire — Rouziers-de-Touraine, France (Recruiting)
- Maison médical de Maen roch — Saint-Brice-en-Coglès, France (Recruiting)
- Maison médicale — Saint-Gilles-Croix-de-Vie, France (Recruiting)
- Maison médicale — Saint-Gilles-Croix-de-Vie, France (Recruiting)
- Maison de soin du Couesnon — Saint-Ouen-des-Alleux, France (Recruiting)
- Cabinet médical — Saint-Romain-sur-Cher, France (Recruiting)
- Maison de santé — Sancerre, France (Recruiting)
- Cabinet médical de la Blanchisserie — Sully-sur-Loire, France (Recruiting)
- Maison de santé — Talensac, France (Recruiting)
- Cabinet des médecins généralistes de TIGY — Tigy, France (Recruiting)
- Cabinet médical — Vildé-Guingalan, France (Recruiting)
Study contacts
- Principal investigator: Eric MENER, Ph D — University of Rennes (Department of general practice)
- Study coordinator: Aurélie VEISLINGER
- Email: Aurelie.VEISLINGER@chu-rennes.fr
- Phone: 2 23 23 33 38
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.