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NCT Number: NCT05000528

Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia

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.

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de NIMES

Nîmes, 30029, France

Location status: Recruiting

Location contact

Anissa MEGZARI

CONTACT

[email protected]

04.66.68.42.36

Beatriz Abril

PRINCIPAL_INVESTIGATOR

Elisa Evangelista

SUB_INVESTIGATOR

Jessy Vaugarny

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapeutic education

Other

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

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

Primary outcomes

  1. Improvement in chronic insomnia between groups

    Time frame: Day 28

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

Secondary outcomes

  1. Change in total sleeping time between groups

    Time frame: Day 28

    Change in total sleeping time (minutes) from inclusion

  2. Change in time in bed between groups

    Time frame: Day 28

    Change in time in bed (minutes) from inclusion

  3. Change in effective sleep

    Time frame: Day 28

    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

  4. Change in sleep latency

    Time frame: Day 28

    % 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

  5. Change in intra-sleep time

    Time frame: Day 28

    Change in time between going to bed and falling asleep (minutes) since inclusion, data collected from patient sleep agenda

  6. Change in anxiety since baseline between groups

    Time frame: Day 28

    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.

  7. Change in depression since baseline between groups

    Time frame: Day 28

    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.

  8. Change in quality of life since baseline

    Time frame: Day 28

    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

  9. Use of hypnotic drugs between groups

    Time frame: Day 28

    Yes/no for each type

  10. Use of anxiolytic drugs between groups

    Time frame: Day 28

    Yes/no for each type

  11. Dose of any hypnotic drugs taken between groups

    Time frame: Day 28

  12. Dose of any anxiolytic drugs taken between groups

    Time frame: Day 28

  13. Completion of therapeutic education sessions of patients in the therapeutic education group

    Time frame: Day 28

    Yes/no

  14. Length of workshops in the therapeutic education group

    Time frame: Day 28

    Minutes

  15. Problems encountered during workshops of patients in the therapeutic education group

    Time frame: Day 28

    Descriptive list made by investigator

  16. Patient-reported reason for refusal to participate in the therapeutic education group

    Time frame: Day 28

    Descriptive list of reasons given by the patient

  17. Improvement in chronic insomnia between groups

    Time frame: Month 4

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

  18. Change in anxiety since baseline between groups

    Time frame: Month 4

    State-Trait Anxiety Inventory (STAI-Y). Self-questionnaire assessing anxiety-status (AE)

  19. Change in depression since baseline between groups

    Time frame: Month 4

    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.

  20. Change in quality of life since baseline

    Time frame: Month 4

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Beatriz Abril

CONTACT

[email protected]

04.66.68.77.30

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: ETP-INSOMNIE

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Aug 11, 2021
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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