Internet Addiction and Sleep Disorders

Internet Addiction Clinical Trial

— ADDICSOM  

Official title:

Internet Addiction and Sleep Disorders

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02390583
• Other study ID #: P120140
• Status: Withdrawn
• Phase: N/A
• First received: March 11, 2015
• Last updated: May 14, 2017
• Start date: September 2016
• Est. completion date: February 2019

Study information

• Verified date: April 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Internet Addiction
• Parasomnias
• Sleep Wake Disorders

Intervention

Behavioral:
• CBT treatment of internet dependence
CBT treatment of internet dependence
• CBT treatment of sleep disorders
CBT treatment of sleep disorders

Locations

Country	Name	City	State
France	Bichat-Claude.Bernard	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of hours spent on line gaming or online gambling		3 months
Secondary	insomnia	measure with Insomnia Severity Index (ISI)	3 and 6months
Secondary	daytime sleepiness	daytime sleepiness with specific scales ( Epworth and KAROLINSKA)	3 and 6 months
Secondary	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
Secondary	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
Secondary	treatment with hypnotics	Number of tablets taken each week	3 and 6 months
Secondary	Depression	score of depression at the MINI questionnaire	3 and 6 months
Secondary	Anxiety	Anxiety scores at the MINI questionnaire	3and 6 months
Secondary	Alcohol dependence	Alcohol dependence assess with severity AUDIT scale	3 and 6 months
Secondary	Nicotine Dependence	assess with Fagerstrom scale	3 and 6 months
Secondary	Other psychoactive agents	assess with RDAPS questionnaire	3 and 6 months
Secondary	Compliance	Compliance will be studied with the participation of patients to CBT groups at 3 and 6 months.	3 and 6 months