Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia

NCT ID: NCT05000528

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2025-09-29

Brief Summary

20 to 30% of the general population suffers from chronic insomnia. Cognitive behavioral therapy (CBT) is the first-line treatment, but unfortunately its implementation is complex. Long waiting times for a consultation / exploration, too short a consultation period, non-reimbursement of specialists and a lack of trained staff make the current care of insomniac patients difficult. Patients are thus treated late, often with heavy drug treatment, dependence on sleeping pills, difficult withdrawal and / or reactive mood disorders. The treatment is therefore limited to advice on sleep hygiene and a restriction of time spent in bed without ultimately intervening in the cognitive domain. Therapeutic education consists of empowering the patient in the management of chronic insomnia through group education workshops. The patient learns the principles of normal sleep, the way in which sleep evolves with aging, the dangers of treatments as well as the rules of sleep hygiene and the behaviors to modify to sleep well. In addition to benefiting from sharing of experience with other patients, therapeutic education makes the care pathway smoother and considerably reduces the long waiting times of the traditional care pathway in consultation.

The study investigators hypothesize that therapeutic education is more effective as a treatment for chronic insomnia than traditional management in individualized consultation (IC). Thus, therapeutic education could constitute an effective alternative to CBT.

Conditions

Sleep Initiation and Maintenance Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Therapeutic education

Group Type: EXPERIMENTAL

therapeutic education

Intervention Type: OTHER

In groups of 5-6, patients will have a one-day therapeutic training session comprising 4 workshops: how to create a sleep agenda; normal sleep; sleep hygiene; medical treatments.

Actimetry

Intervention Type: OTHER

once from inclusion for 2 weeks, second for 2 weeks starting 2 weeks after intervention

Individualized consultation

Group Type: ACTIVE_COMPARATOR

Actimetry

Intervention Type: OTHER

once from inclusion for 2 weeks, second for 2 weeks starting 2 weeks after intervention

Interventions

therapeutic education

In groups of 5-6, patients will have a one-day therapeutic training session comprising 4 workshops: how to create a sleep agenda; normal sleep; sleep hygiene; medical treatments.

Intervention Type: OTHER

Actimetry

once from inclusion for 2 weeks, second for 2 weeks starting 2 weeks after intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• The patient must have given their free and informed consent
• The patient must be a member or beneficiary of a health insurance plan
• Patient must understand and read French
• Patient with ICSD-3 diagnostic criteria for chronic insomnia: ISI score > 14/28.

Exclusion Criteria

• Patient with cognitive impairment as assessed by the investigator
• Patient with shift work
• Patients scoring > 10/24 on the Epworth sleepiness scale
• Patient suffering from medical or psychiatric illnesses which may, in the opinion of the investigator, compromise the subject's state of health or ability to participate in the study.
• Patient with chronic alcohol consumption or drug abuse
• Patient unable to express consent.
• Pregnant, parturient or breastfeeding patient.
• The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beatriz Abril

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nīmes

Locations

CHU de NIMES

Nîmes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Beatriz Abril

Role: CONTACT

Phone: 04.66.68.77.30

Email: beatriz.abril@chu-nimes.fr

Facility Contacts

Anissa MEGZARI

Role: primary

Other Identifiers

NIMAO/2020-2/BA-1

Identifier Type: -

Identifier Source: org_study_id