Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia (ETP-INSOMNIE)
Primary Purpose
Sleep Initiation and Maintenance Disorders
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
therapeutic education
Actimetry
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders
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
Sites / Locations
- CHU de NIMESRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Therapeutic education
Individualized consultation
Arm Description
Outcomes
Primary Outcome Measures
Improvement in chronic insomnia between groups
Change in Insomnia Severity Index (ISI) score (Score between 0 - 28) from inclusion
Secondary Outcome Measures
Change in total sleeping time between groups
Change in total sleeping time (minutes) from inclusion
Change in time in bed between groups
Change in time in bed (minutes) from inclusion
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
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
Change in intra-sleep time
Change in time between going to bed and falling asleep (minutes) since inclusion, data collected from patient sleep agenda
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.
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.
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
Use of hypnotic drugs between groups
Yes/no for each type
Use of anxiolytic drugs between groups
Yes/no for each type
Dose of any hypnotic drugs taken between groups
Dose of any anxiolytic drugs taken between groups
Completion of therapeutic education sessions of patients in the therapeutic education group
Yes/no
Length of workshops in the therapeutic education group
Minutes
Problems encountered during workshops of patients in the therapeutic education group
Descriptive list made by investigator
Patient-reported reason for refusal to participate in the therapeutic education group
Descriptive list of reasons given by the patient
Full Information
NCT ID
NCT05000528
First Posted
July 22, 2021
Last Updated
January 11, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT05000528
Brief Title
Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia
Acronym
ETP-INSOMNIE
Official Title
Etude Pilote d'évaluation de l'efficacité de l'ETP Sur l'Insomnie Chronique
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2022 (Actual)
Primary Completion Date
September 29, 2024 (Anticipated)
Study Completion Date
September 29, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic education
Arm Type
Experimental
Arm Title
Individualized consultation
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
therapeutic education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Actimetry
Intervention Description
once from inclusion for 2 weeks, second for 2 weeks starting 2 weeks after intervention
Primary Outcome Measure Information:
Title
Improvement in chronic insomnia between groups
Description
Change in Insomnia Severity Index (ISI) score (Score between 0 - 28) from inclusion
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Change in total sleeping time between groups
Description
Change in total sleeping time (minutes) from inclusion
Time Frame
Day 28
Title
Change in time in bed between groups
Description
Change in time in bed (minutes) from inclusion
Time Frame
Day 28
Title
Change in effective sleep
Description
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
Title
Change in sleep latency
Description
% 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
Title
Change in intra-sleep time
Description
Change in time between going to bed and falling asleep (minutes) since inclusion, data collected from patient sleep agenda
Time Frame
Day 28
Title
Change in anxiety since baseline between groups
Description
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
Title
Change in depression since baseline between groups
Description
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
Title
Change in quality of life since baseline
Description
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
Title
Use of hypnotic drugs between groups
Description
Yes/no for each type
Time Frame
Day 28
Title
Use of anxiolytic drugs between groups
Description
Yes/no for each type
Time Frame
Day 28
Title
Dose of any hypnotic drugs taken between groups
Time Frame
Day 28
Title
Dose of any anxiolytic drugs taken between groups
Time Frame
Day 28
Title
Completion of therapeutic education sessions of patients in the therapeutic education group
Description
Yes/no
Time Frame
Day 28
Title
Length of workshops in the therapeutic education group
Description
Minutes
Time Frame
Day 28
Title
Problems encountered during workshops of patients in the therapeutic education group
Description
Descriptive list made by investigator
Time Frame
Day 28
Title
Patient-reported reason for refusal to participate in the therapeutic education group
Description
Descriptive list of reasons given by the patient
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beatriz Abril
Phone
04.66.68.77.30
Email
beatriz.abril@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz Abril
Organizational Affiliation
Centre Hospitalier Universitaire de Nīmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de NIMES
City
Nimes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa MEGZARI
Phone
04.66.68.42.36
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Beatriz Abril
First Name & Middle Initial & Last Name & Degree
Elisa Evangelista
First Name & Middle Initial & Last Name & Degree
Jessy Vaugarny
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia
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