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

Overview

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.

Interventions

• Other "Standard care" control group (without hypnosis)
  Randomization stratification on insomnia severity. In the "Standard care" group, the investigating physician will not change his or her current practice as part of the study. Treatment will be the same as usual, whether drug-based or not (psychotherapy, etc.), with the exception of hypnosis. The patients will be reviewed at 3 months and 6 months (+/- 1 week) after randomization (D0). The following study information and questionnaires will be completed according to patients' responses: ISI and PS
• Other Experimental group: "E2R hypnosis"
  Randomization stratification on insomnia severity. For the patients randomized to the Hypnosis E2R arm, patients summoned within 15 days to 3 weeks of inclusion for their first hypnotherapy session with the hypnotherapist. All patients will receive 4 hypnotherapy sessions over 6 weeks using the E2R method. The patients will be reviewed at 3 months and 6 months (+/- 1 week) after randomization (D0). The following study information and questionnaires will be completed according to patients' respo

Primary outcome measures

• Severity of Insomnia assessed by the Insomnia Severity Index (ISI) [Time frame: 6 months]

Secondary outcome measures (12)

• Severity of Insomnia assessed by the Insomnia Severity Index (ISI) [Time frame: 3 months]
• Number of responders assessed by the Insomnia Severity index (ISI) [Time frame: 3 months]
• Number of responders assessed by the Insomnia Severity index (ISI) [Time frame: 6 months]
• Number of partial responders assessed by the Insomnia Severity index (ISI) [Time frame: 3 months]
• Number of partial responders assessed by the Insomnia Severity index (ISI) [Time frame: 6 months]
• Number of non-responders assessed by the Insomnia Severity index (ISI) [Time frame: 3 months]
• Number of non-responders assessed by the Insomnia Severity index (ISI) [Time frame: 6 months]
• Consumption of Benzodiazepine and related drug assessed by the prescription and patient interview [Time frame: 3 months]
• Consumption of Benzodiazepine and related drug assessed by the prescription and patient interview [Time frame: 6 months]
• Sleep quality assessed by the Pittsburg Sleep Quality Index (PSQI) [Time frame: 3 months]
• Sleep quality assessed by the Pittsburg Sleep Quality Index (PSQI) [Time frame: 6 months]
• Incidence of neuropsychiatric Non-Serious Adverse Events (Safety) of E2R hypnosis method in primary care [Time frame: 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 35 centers

• Cabinet médical — Bain-de-Bretagne
• Cabinet médical de Plaisance — Bouaye
• Cabinet médical de Plaisance — Bouaye
• Cabinet médical de Breteil — Breteil
• Cabinet médical — Cesson-Sévigné
• Cabinet médical du Linon — Combourg
• Cabinet médical Sycamore — Contres
• Cabinet médical de Corps Nuds — Corps-Nuds
• … and 27 more centers

Identifiers

NCT: NCT06898099 · 35RC22_8973_HypERR · 2024-A01366-41

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗