Internet Addiction and Sleep Disorders

Study Overview
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Brief Summary
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This is an open label randomized controlled trial, comparing two modes of treatment for internet addiction (gaming or gambling online) with sleep disorders associated.

Detailed Description
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We will check sleep disorders among patients presenting internet dependence. Diagnosis will be followed by a specific treatment during three months. This treatment is expected to reduce prevalence of internet dependence and associated addictive disorders (alchohol, nicotine) . rate of sleep disorders is also expected to decrease under treatment. This is an open label randomized controlled trial, comparing two modes of treatment for internet addiction (gaming or gambling online) with sleep disorders associated. Patients will be randomised in two arms : controls (CBT treatment of Internet dependence) and intervention (CBT treatment of addiction plus CBT treatment of sleep disorders).

Official Title
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Internet Addiction and Sleep Disorders

Conditions
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Internet Addiction

Intervention / Treatment
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* Behavioral: CBT treatment of internet dependence
* Behavioral: CBT treatment of sleep disorders


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Internet addiction (Young scale ≥5) Online compulsive gambling ( DSM IV scale for pathological gambling and SOGS) and/or addiction to online gaming (problem video game playing ≥ 5) sleep latency >45 min/night and more than 3 nights a week subjective total sleep time <6h30/night more than 3 nights a week Adult patient Exclusion Criteria: cognitive impairments, memory disorders, non french-speaking patients already known and on treatment sleep pathologies somatic conditions non compatible with clinical evaluation cybersex dependance Treatment with dopaminergic agents patients under jurisdictional assistance patients non covered by the french health system non consenting patients History of Healthcare for internet dependence Patients already treated for internet dependance pregnant or lactating women Patients already participating in other studies on internet dependance and sleeping disorders suicide attempt before inclusion

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>CBT treatment of internet dependence each two weeks during 3 months | Behavioral: CBT treatment of internet dependence<br>* CBT treatment of internet dependence<br>|
| Experimental: intervention<br>CBT treatment of internet dependence plus CBT treatment of sleep disorders during 3 months | Behavioral: CBT treatment of internet dependence<br>* CBT treatment of internet dependence<br>Behavioral: CBT treatment of sleep disorders<br>* CBT treatment of sleep disorders<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of hours each week spent gaming or online gambling | The evaluation period will be 7 days of follow-up visit at 6 months. Each patient will complete a connection agenda that will provide the therapist during follow-up visits. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hours spent on line gaming or online gambling |  | 3 months | 
| insomnia | measure with Insomnia Severity Index (ISI) | 3 and 6months | 
| daytime sleepiness | daytime sleepiness with specific scales ( Epworth and KAROLINSKA) | 3 and 6 months | 
| total sleep time | total sleep time (actimetry, sleep agenda) Actimetry results will be centrally reviewed by experts blinded to realization date | 3 and 6 months | 
| number of awakenings during night | number of awakenings during night (actimetry) Actimetry results will be centrally reviewed by experts blinded to realization date | 3 and 6 months | 
| treatment with hypnotics | Number of tablets taken each week | 3 and 6 months | 
| Depression | score of depression at the MINI questionnaire | 3 and 6 months | 
| Anxiety | Anxiety scores at the MINI questionnaire | 3and 6 months | 
| Alcohol dependence | Alcohol dependence assess with severity AUDIT scale | 3 and 6 months | 
| Nicotine Dependence | assess with Fagerstrom scale | 3 and 6 months | 
| Other psychoactive agents | assess with RDAPS questionnaire | 3 and 6 months | 
| Compliance | Compliance will be studied with the participation of patients to CBT groups at 3 and 6 months. | 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Internet dependence, Sleep disorders, pathological gambling