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

Overview

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.

Interventions

• Other 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.
• Other Actimetry
  once from inclusion for 2 weeks, second for 2 weeks starting 2 weeks after intervention

Primary outcome measures

• Improvement in chronic insomnia between groups [Time frame: Day 28]

Secondary outcome measures (12)

• Change in total sleeping time between groups [Time frame: Day 28]
• Change in time in bed between groups [Time frame: Day 28]
• Change in effective sleep [Time frame: Day 28]
• Change in sleep latency [Time frame: Day 28]
• Change in intra-sleep time [Time frame: Day 28]
• Change in anxiety since baseline between groups [Time frame: Day 28]
• Change in depression since baseline between groups [Time frame: Day 28]
• Change in quality of life since baseline [Time frame: Day 28]
• Use of hypnotic drugs between groups [Time frame: Day 28]
• Use of anxiolytic drugs between groups [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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 1 center

• CHU de NIMES — Nîmes

Identifiers

NCT: NCT05000528 · NIMAO/2020-2/BA-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗