Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia (ETP-INSOMNIE)

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

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 Overview

• Status: Recruiting
• Conditions: Sleep Initiation and Maintenance Disorders
• Intervention / Treatment: Other: therapeutic education; Other: Actimetry

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beatriz Abril; Phone Number: 04.66.68.77.30; Email: beatriz.abril@chu-nimes.fr

Study Locations

• France
  • Nimes, France, 30029
    • Recruiting
    • CHU de Nîmes
    • Principal Investigator: Beatriz Abril
    • Sub-Investigator: Elisa Evangelista
    • Sub-Investigator: Jessy Vaugarny
    • Contact: Anissa Megzari; Phone Number: 04.66.68.42.36; Email: drc@chu-nimes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapeutic education	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
Active Comparator: Individualized consultation	Other: Actimetry; once from inclusion for 2 weeks, second for 2 weeks starting 2 weeks after intervention

What is the study measuring?

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
Improvement in chronic insomnia between groups	Change in Insomnia Severity Index (ISI) score (Score between 0 - 28) from inclusion	Month 4
Change in anxiety since baseline between groups	State-Trait Anxiety Inventory (STAI-Y). Self-questionnaire assessing anxiety-status (AE)	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.	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	Month 4

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Beatriz Abril, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): September 29, 2024
• Study Completion (Estimated): September 29, 2025

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: NIMAO/2020-2/BA-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No