Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia

Study Overview
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Brief Summary
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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.

Official Title
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Etude Pilote d'évaluation de l'efficacité de l'ETP Sur l'Insomnie Chronique

Conditions
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Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Other: therapeutic education
* Other: Actimetry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic education<br> | Other: therapeutic education<br>* 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.<br>Other: Actimetry<br>* once from inclusion for 2 weeks, second for 2 weeks starting 2 weeks after intervention<br>|
| Active Comparator: Individualized consultation<br> | Other: Actimetry<br>* once from inclusion for 2 weeks, second for 2 weeks starting 2 weeks after intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in chronic insomnia between groups | Change in Insomnia Severity Index (ISI) score (Score between 0 - 28) from inclusion | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total sleeping time between groups | Change in total sleeping time (minutes) from inclusion | Day 28 | 
| Change in time in bed between groups | Change in time in bed (minutes) from inclusion | Day 28 | 
| Change in effective sleep | Time between going to bed and falling asleep (minutes). Average time for the 2 weeks following inclusion versus the 2 weeks preceding the study end measured by actimetry bracelet | Day 28 | 
| Change in sleep latency | % total sleeping time / time in bed. Average time for the 2 weeks following inclusion versus the 2 weeks preceding the study end measured by actimetry bracelet | Day 28 | 
| Change in intra-sleep time | Change in time between going to bed and falling asleep (minutes) since inclusion, data collected from patient sleep agenda | Day 28 | 
| Change in anxiety since baseline between groups | State-Trait Anxiety Inventory (STAI-Y). Self-questionnaire assessing anxiety-status (AE) reflecting the current emotional state and anxiety-trait (AT) reflecting the usual emotional state. Total score 20-80. | Day 28 | 
| Change in depression since baseline between groups | Beck Depression Inventory (BDI). The total score is obtained by adding the scores of the 13 items. This score will be between 0 and 63. The higher the score, the more depressed the subject is. | Day 28 | 
| Change in quality of life since baseline | Dysfunctional Beliefs and Attitudes about Sleep - 16 (DBAS-16). This self-questionnaire is composed of 16 items: Perceived consequences of insomnia (5 items), Worry/impotence about insomnia (6 items), Sleep expectations (2 items), Medication (3 items). The global score is an average of the scores of each item, ranging from 0 to 10. The higher the score, the more dysfunctional beliefs and attitudes about sleep | Day 28 | 
| Use of hypnotic drugs between groups | Yes/no for each type | Day 28 | 
| Use of anxiolytic drugs between groups | Yes/no for each type | Day 28 | 
| Dose of any hypnotic drugs taken between groups |  | Day 28 | 
| Dose of any anxiolytic drugs taken between groups |  | Day 28 | 
| Completion of therapeutic education sessions of patients in the therapeutic education group | Yes/no | Day 28 | 
| Length of workshops in the therapeutic education group | Minutes | Day 28 | 
| Problems encountered during workshops of patients in the therapeutic education group | Descriptive list made by investigator | Day 28 | 
| Patient-reported reason for refusal to participate in the therapeutic education group | Descriptive list of reasons given by the patient | Day 28 |