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Internet Addiction and Sleep Disorders (ADDICSOM)

This study has been withdrawn prior to enrollment.
(no patient)
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02390583
First received: March 11, 2015
Last updated: May 14, 2017
Last verified: April 2017
  Purpose
This is an open label randomized controlled trial, comparing two modes of treatment for internet addiction (gaming or gambling online) with sleep disorders associated.

Condition Intervention
Internet Addiction Behavioral: CBT treatment of internet dependence Behavioral: CBT treatment of sleep disorders

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Internet Addiction and Sleep Disorders

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 0
Study Start Date: September 2016
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02390583

Locations
France
Bichat-Claude.Bernard
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Lejoyeux Lejoyeux, Professor Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02390583     History of Changes
Other Study ID Numbers: P120140
Study First Received: March 11, 2015
Last Updated: May 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.


Keywords provided by Assistance Publique - Hôpitaux de Paris:
Internet dependence
Sleep disorders
pathological gambling

Additional relevant MeSH terms:
Behavior, Addictive
Sleep Wake Disorders
Parasomnias
Compulsive Behavior
Impulsive Behavior
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on July 25, 2017