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

Rennes University Hospital

Status: Begins enrollment in 4 months

Conditions: Chronic Insomnia

Treatments: Other: Experimental group: "E2R hypnosis"; Other: "Standard care" control group (without hypnosis)

Study type: Interventional

Funder types: Other

Identifiers

NCT06898099

2024-A01366-41 (Registry Identifier)

35RC22_8973_HypERR

Details and patient eligibility

About

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).

Full 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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Standard care

Active Comparator group

Description:

Patients will receive the usual care offered by their GP, the investigator in the study (except hypnosis).

Treatment:

Other: "Standard care" control group (without hypnosis)

E2R hypnosis

Experimental group

Description:

4 x 30-minute hypnotherapy sessions over 6 weeks by the hypnotherapist using the E2R method (with self-hypnosis)

Treatment:

Other: Experimental group: "E2R hypnosis"