Clinical trial NCT05000528: Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia
Official title: Etude Pilote d'évaluation de l'efficacité de l'ETP Sur l'Insomnie Chronique
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Improvement in chronic insomnia between groups
timeFrame: Day 28
Secondary outcomes:
measure: Change in total sleeping time between groups
timeFrame: Day 28
measure: Change in time in bed between groups
timeFrame: Day 28
measure: Change in effective sleep
timeFrame: Day 28
measure: Change in sleep latency
timeFrame: Day 28
measure: Change in intra-sleep time
timeFrame: Day 28
measure: Change in anxiety since baseline between groups
timeFrame: Day 28
measure: Change in depression since baseline between groups
timeFrame: Day 28
measure: Change in quality of life since baseline
timeFrame: Day 28
measure: Use of hypnotic drugs between groups
timeFrame: Day 28
measure: Use of anxiolytic drugs between groups
timeFrame: Day 28
measure: Dose of any hypnotic drugs taken between groups
timeFrame: Day 28
measure: Dose of any anxiolytic drugs taken between groups
timeFrame: Day 28
measure: Completion of therapeutic education sessions of patients in the therapeutic education group
timeFrame: Day 28
measure: Length of workshops in the therapeutic education group
timeFrame: Day 28
measure: Problems encountered during workshops of patients in the therapeutic education group
timeFrame: Day 28
measure: Patient-reported reason for refusal to participate in the therapeutic education group
timeFrame: Day 28
measure: Improvement in chronic insomnia between groups
timeFrame: Month 4
measure: Change in anxiety since baseline between groups
timeFrame: Month 4
measure: Change in depression since baseline between groups
timeFrame: Month 4
measure: Change in quality of life since baseline
timeFrame: Month 4
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU de NIMES
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Beatriz Abril
role: PRINCIPAL_INVESTIGATOR
References: