Evaluating the Efficacy of the Management of an Online Program of Cognitive Behavioral Therapy for Primary Insomnia

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Pilot Study Evaluating the Efficacy of the Management of an Online Program of Cognitive Behavioral Therapy for Primary Insomnia

Conditions
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Chronic Insomnia

Intervention / Treatment
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* Other: cognitive behavioral therapy online
* Other: psychoeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 20 and 65 disorder diagnosis of chronic insomnia (according to Diagnostic and Statistical Manual-5) sleep efficiency <80% Index severe insomnia: ISI> 14/28 have a computer at home Practicing internet regularly in everyday life have a personal email address Exclusion Criteria: Clinically suffer from insomnia comorbid linked to other sleep disorders Presenting an unbalanced psychiatric disorder Have Score Beck Depression Inventory (BDI-II) >29 Have neurological disorders Have severe medical conditions that can affect the quality of sleep Have Hypnotic, Anxiolytic, antidepressants Treatment > 2 Have antipsychotics, opioids, anticonvulsants, anti-parkinson treatment Having a disorder of substance use (alcohol, drugs) in the last 6 months Having undertaken a meridian trance journey (± 3H) in the preceding month or during the study period Already be treated with CBT-I

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cognitive behavioral therapy online<br>patients receive cognitive behavioral therapy via an online program | Other: cognitive behavioral therapy online<br>* The cognitive behavioral therapy online program is delivered through an accessible web application on a web browser with a personal password<br>|
| Other: no cognitive behavioral therapy online<br>patients receive psychoeducation by a doctor | Other: psychoeducation<br>* the psychoeducation is delivered by a doctor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, behavioral and cognitive therapies