Clinical trial NCT06898099: Evaluation of the Efficacy of E2R Hypnotherapy in the Management of Chronic Insomnia in Primary Care (HypERR)
Official title: Evaluation of the Efficacy of E2R Hypnotherapy in the Management of Chronic Insomnia in Primary Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Insomnia
Keywords: chronic insomnia
E2R hypnosis
emotion-focused therapy
primary care
general medicine
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: University of Rennes
First posted: 2025-03-27
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The HypERR study is a multicenter, randomized, open-label study designed to confirm the efficacy of a hypotherapy method called E2R in the management of chronic insomnia, by comparing it with standard care (without hypnosis)
Primary purpose: TREATMENT

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).

Detailed description: The selection and inclusion of patients will be carried out by 34 GPs (General Practitioner), the study investigators. They will then randomize their patients into one of 2 groups: the E2R hypnosis group versus the "standard care" control group (without hypnosis).

Patients randomized to the hypnosis group will be referred by their GP to a hypnotherapist in their area within a 30-minute radius. They will receive 4 x 30-minute hypnotherapy sessions over 6 weeks.

For patients randomized to the control group, the GP will be free to implement psychotherapy and/or other non-medication interventions as usual (with the exception of hypnosis) and/or medication.

Then, all patients will be reviewed at 3 and 6 months by their GP (+/- 1 week) after randomization (D0) to assess the study criteria.

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.

Primary outcomes:
measure: Severity of Insomnia assessed by the Insomnia Severity Index (ISI)
timeFrame: 6 months
Secondary outcomes:
measure: Severity of Insomnia assessed by the Insomnia Severity Index (ISI)
timeFrame: 3 months
measure: Number of responders assessed by the Insomnia Severity index (ISI)
timeFrame: 3 months
measure: Number of responders assessed by the Insomnia Severity index (ISI)
timeFrame: 6 months
measure: Number of partial responders assessed by the Insomnia Severity index (ISI)
timeFrame: 3 months
measure: Number of partial responders assessed by the Insomnia Severity index (ISI)
timeFrame: 6 months
measure: Number of non-responders assessed by the Insomnia Severity index (ISI)
timeFrame: 3 months
measure: Number of non-responders assessed by the Insomnia Severity index (ISI)
timeFrame: 6 months
measure: Consumption of Benzodiazepine and related drug assessed by the prescription and patient interview
timeFrame: 3 months
measure: Consumption of Benzodiazepine and related drug assessed by the prescription and patient interview
timeFrame: 6 months
measure: Sleep quality assessed by the Pittsburg Sleep Quality Index (PSQI)
timeFrame: 3 months
measure: Sleep quality assessed by the Pittsburg Sleep Quality Index (PSQI)
timeFrame: 6 months
measure: Safety of E2R hypnosis method in primary care assessed by the number and the nature of neuropsychiatric Non-Serious Adverse Events
timeFrame: 6 months
measure: Safety of E2R hypnosis method in primary care assessed by the number and the nature of Serious Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Bain de Bretagne
country: France
facility: Center 12
city: Bouaye
country: France
facility: Center 21
city: Bouaye
country: France
facility: Center 22
city: Breteil
country: France
facility: Center 13
city: Cesson-Sévigné
country: France
facility: Center 11
city: Combourg
country: France
facility: Center 8
city: Contres
country: France
facility: Center 28
city: Corps-Nuds
country: France
facility: Center 10
city: Crac'h
country: France
facility: Center 14
city: Dol de Bretagne
country: France
facility: Center 1
city: Guer
country: France
facility: Center 15
city: Iffendic
country: France
facility: Center 4
city: Joué les Tours
country: France
facility: Center 34
city: Jugon Les lacs
country: France
facility: Center 19
city: La Chapelle Saint Ursin
country: France
facility: Center 32
city: La Chapelle-des-Fougeretz
country: France
facility: Center 7
city: Nantes
country: France
facility: Center 25
city: Pleudihen-sur-Rance
country: France
facility: Center 18
city: Ploërmel
country: France
facility: Center 16
city: Pont St Martin
country: France
facility: Center 23
city: Pont St Martin
country: France
facility: Center 24
city: Questembert
country: France
facility: Center 17
city: Rennes
country: France
facility: Center 5
city: Rennes
country: France
facility: Center 6
city: Saint Brice en Coglès
country: France
facility: Center 2
city: Saint Ouen des Alleux
country: France
facility: Center 3
city: Saint Romain Sur Cher
country: France
facility: Center 29
city: Saint-Gilles-Croix-de-Vie
country: France
facility: Center 26
city: Saint-Gilles-Croix-de-Vie
country: France
facility: Center 27
city: Sancerre
country: France
facility: Center 33
city: Sully-sur-Loire
country: France
facility: Center 30
city: Talensac
country: France
facility: Center 9
city: Tigy
country: France
facility: Centerr 31
city: Vildé Guingalan
country: France
facility: Center 20
Study officials:
affiliation: University of Rennes (Department of general practice)
name: Eric MENER, Ph D
role: PRINCIPAL_INVESTIGATOR
References: