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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
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.
once from inclusion for 2 weeks, second for 2 weeks starting 2 weeks after intervention
CHU de NIMES
Nîmes, France
RECRUITINGImprovement in chronic insomnia between groups
Change in Insomnia Severity Index (ISI) score (Score between 0 - 28) from inclusion
Time frame: Day 28
Change in total sleeping time between groups
Change in total sleeping time (minutes) from inclusion
Time frame: Day 28
Change in time in bed between groups
Change in time in bed (minutes) from inclusion
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Day 28
Use of hypnotic drugs between groups
Yes/no for each type
Time frame: Day 28
Use of anxiolytic drugs between groups
Yes/no for each type
Time frame: Day 28
Dose of any hypnotic drugs taken between groups
Time frame: Day 28
Dose of any anxiolytic drugs taken between groups
Time frame: Day 28
Completion of therapeutic education sessions of patients in the therapeutic education group
Yes/no
Time frame: Day 28
Length of workshops in the therapeutic education group
Minutes
Time frame: Day 28
Problems encountered during workshops of patients in the therapeutic education group
Descriptive list made by investigator
Time frame: Day 28
Patient-reported reason for refusal to participate in the therapeutic education group
Descriptive list of reasons given by the patient
Time frame: Day 28
Improvement in chronic insomnia between groups
Change in Insomnia Severity Index (ISI) score (Score between 0 - 28) from inclusion
Time frame: Month 4
Change in anxiety since baseline between groups
State-Trait Anxiety Inventory (STAI-Y). Self-questionnaire assessing anxiety-status (AE)
Time frame: Month 4
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.
Time frame: Month 4
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
Time frame: Month 4
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