Internet Addiction and Sleep Disorders (ADDICSOM)

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

Study Overview

• Status: Withdrawn
• Conditions: Internet Addiction
• Intervention / Treatment: Behavioral: CBT treatment of internet dependence; Behavioral: CBT treatment of sleep disorders

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75018
    • Bichat-Claude.Bernard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control; CBT treatment of internet dependence each two weeks during 3 months	Behavioral: CBT treatment of internet dependence; CBT treatment of internet dependence
Experimental: intervention; CBT treatment of internet dependence plus CBT treatment of sleep disorders during 3 months	Behavioral: CBT treatment of internet dependence; CBT treatment of internet dependence; Behavioral: CBT treatment of sleep disorders; CBT treatment of sleep disorders

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Lejoyeux Lejoyeux, Professor, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: March 11, 2015
• First Submitted That Met QC Criteria: March 11, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 14, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Sleep disorders; pathological gambling; Internet dependence
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Compulsive Behavior; Impulsive Behavior; Sleep Wake Disorders; Parasomnias; Behavior, Addictive; Internet Addiction Disorder
• Other Study ID Numbers: P120140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

At the end of the study, patient could be informed of result of the study if they wish.

No individual result will be communicate.