Internet Addiction and Sleep Disorders

Not Applicable

Withdrawn

• Conditions: Internet Addiction
• Interventions: Behavioral: CBT treatment of internet dependence; Behavioral: CBT treatment of sleep disorders

• Registration Number: NCT02390583
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2015-03-11
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-17
• Study Start: 2016-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-05-14
• Last Update Posted: 2017-05-16
• Primary Completion: 2019-02
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	CBT treatment of internet dependence	CBT treatment of internet dependence each two weeks during 3 months
intervention	CBT treatment of internet dependence	CBT treatment of internet dependence plus CBT treatment of sleep disorders during 3 months
intervention	CBT treatment of sleep disorders	CBT treatment of internet dependence plus CBT treatment of sleep disorders during 3 months

Primary Outcome Measures

Name	Time	Method
number of hours each week spent gaming or online gambling	6 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bichat-Claude.Bernard; 🇫🇷 Paris, France