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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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The purpose of this study is to evaluate the effectiveness of the management of chronic primary insomnia patients by a computer program guidance of behavioral and cognitive therapies for insomnia (BCT-I).
Chronic insomnia is a common sleep disorder (prevalence = 10%) and a risk identified on the physical and mental health. Currently, the treatment involves the prescription of drug treatments by general practitioners, which may be unsuitable for the medium term. It is better to turn to Behavioral and Cognitive Therapies for Insomnia (BCT-I) in the case of primary chronic insomnia. The objective of this study is to evaluate the effectiveness of a computer program guidance BCT-I in patients with chronic primary insomnia. This biomedical research psychotherapeutic assessment will be randomized, controlled versus psychoeducation and conducted in 46 patients with chronic primary insomnia (defined according to Diagnostic and Statistical Manual-5) for which a supported by BCT-I is indicated.
The 46 patients will be randomized into two groups. The subjects in Group 1 will be supported by BCT-I online. And the subjects in group 2 will receive psychoeducation. All patients will be followed by the research team for three months, during which 3 visits (V0 = pre-selection; V1 = visit of randomization and start of the program; V2 = 3 months follow-up visit and end of the study) will be performed in the University Hospital Sleep Disorder Unit of Montpellier. Patients in Group 1 will conduct BCT-I online at home therapy. Patients in group 2 will receive a structured 45-minute session information insomnia (psychoeducation = work performed daily by clinicians in charge of insomnia problems) to the visit 1. All patients in the study will be equipped 2 sensors for the registration of sleep data.
The primary endpoint will be based on the severity of insomnia measured by the ISI after the last online psychotherapy session (3 months) between the 2 groups of patients (BCT-I online and without treatment - psychoeducation ). The analyse efficacity to be conducted by intention to treat.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cognitive behavioral therapy online | Experimental | patients receive cognitive behavioral therapy via an online program |
|
| no cognitive behavioral therapy online | Other | patients receive psychoeducation by a doctor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive behavioral therapy online | Other | The cognitive behavioral therapy online program is delivered through an accessible web application on a web browser with a personal password |
| Measure | Description | Time Frame |
|---|---|---|
| insomnia severity measured | The primary endpoint will focus on the severity of insomnia measured by the Index severe insomnia (ISI) at the end of the last session of CBT (3 months) between the 2 groups of patients (CBT-I online and psychoeducation). | 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| sleep efficiency | duration of of sleep time compared to the time window passed to bed | 100 days |
| Sleep latency | collection of data with actiwatch2 sensor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dauvilliers Yves | Unit of sleep disorders | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10394613 | Background | Leger D, Levy E, Paillard M. The direct costs of insomnia in France. Sleep. 1999 May 1;22 Suppl 2:S394-401. | |
| 1887276 | Background | Leigh JP. Employee and job attributes as predictors of absenteeism in a national sample of workers: the importance of health and dangerous working conditions. Soc Sci Med. 1991;33(2):127-37. doi: 10.1016/0277-9536(91)90173-a. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| psychoeducation | Other | the psychoeducation is delivered by a doctor |
|
| 100 days |
| duration of night wakings | collection of data with actiwatch2 sensor | 100 days |
| total sleep time | The total sleep time measured by sleep diary and actometer (Actiwatch 2 Sleep). | 100 days |
| Sleep quality | sleepiness score assessed by a specific questionnaire | 100 days |
| quantity of hypnotic treatment | number of hypnotic which will be consume by patient | 100 days |
| adherence to CBT-I program online | the number of steps performed in the program, and the weekly frequency of connection. | 100 days |
| 8037252 | Background | Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry. 1994 Aug;151(8):1172-80. doi: 10.1176/ajp.151.8.1172. |
| 7896994 | Background | Murtagh DR, Greenwood KM. Identifying effective psychological treatments for insomnia: a meta-analysis. J Consult Clin Psychol. 1995 Feb;63(1):79-89. doi: 10.1037//0022-006x.63.1.79. |
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| 11772681 | Background | Smith MT, Perlis ML, Park A, Smith MS, Pennington J, Giles DE, Buysse DJ. Comparative meta-analysis of pharmacotherapy and behavior therapy for persistent insomnia. Am J Psychiatry. 2002 Jan;159(1):5-11. doi: 10.1176/appi.ajp.159.1.5. |
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| Background | I. Okajima, Y. Komada, and Y. Inoue, A meta-analysis on the treatment effectiveness of cognitive behavioral therapy for primary insomnia. Sleep and Biological Rhythms, 2011. 9(1): p. 24-34. |
| 22654196 | Background | Espie CA, Kyle SD, Williams C, Ong JC, Douglas NJ, Hames P, Brown JS. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep. 2012 Jun 1;35(6):769-81. doi: 10.5665/sleep.1872. |
| 19581560 | Background | Ritterband LM, Thorndike FP, Gonder-Frederick LA, Magee JC, Bailey ET, Saylor DK, Morin CM. Efficacy of an Internet-based behavioral intervention for adults with insomnia. Arch Gen Psychiatry. 2009 Jul;66(7):692-8. doi: 10.1001/archgenpsychiatry.2009.66. |
| 17162986 | Background | Morin CM, Bootzin RR, Buysse DJ, Edinger JD, Espie CA, Lichstein KL. Psychological and behavioral treatment of insomnia:update of the recent evidence (1998-2004). Sleep. 2006 Nov;29(11):1398-414. doi: 10.1093/sleep/29.11.1398. |
| 17308547 | Background | NIH State-of-the-Science Conference Statement on manifestations and management of chronic insomnia in adults. NIH Consens State Sci Statements. 2005 Jun 13-15;22(2):1-30. |
| 18853708 | Background | Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008 Oct 15;4(5):487-504. |
| 24014057 | Background | Thorndike FP, Ritterband LM, Gonder-Frederick LA, Lord HR, Ingersoll KS, Morin CM. A randomized controlled trial of an internet intervention for adults with insomnia: effects on comorbid psychological and fatigue symptoms. J Clin Psychol. 2013 Oct;69(10):1078-93. doi: 10.1002/jclp.22032. Epub 2013 Aug 28. |
| 11438246 | Background | Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4. |
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| D001523 |
| Mental Disorders |