Clinical Trial: Internet Addiction and Sleep Disorders

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Internet Addiction and Sleep Disorders

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 Summary:

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).


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: number of hours each week spent gaming or online gambling [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome:

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


Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: March 11, 2015
Date Started: September 2016
Date Completion: February 2019
Last Updated: May 14, 2017
Last Verified: April 2017