Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • therapeutic education

    Other intervention

    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

    Other intervention

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

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Therapeutic educationExperimental treatment 2 interventions
Group B: Individualized consultationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Improvement in chronic insomnia between groups

Change in Insomnia Severity Index (ISI) score (Score between 0 - 28) from inclusion

Time frame
Day 28

Secondary outcomes

1

Change in total sleeping time between groups

Change in total sleeping time (minutes) from inclusion

Time frame
Day 28
2

Change in time in bed between groups

Change in time in bed (minutes) from inclusion

Time frame
Day 28
3

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
4

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

Other outcomes

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