E2R hypnotherapy for chronic insomnia in primary care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.