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Internet Addiction and Sleep Disorders (ADDICSOM)

Primary Purpose

Internet Addiction

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CBT treatment of internet dependence
CBT treatment of sleep disorders
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Internet Addiction focused on measuring Internet dependence, Sleep disorders, pathological gambling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bichat-Claude.Bernard

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control

intervention

Arm Description

CBT treatment of internet dependence each two weeks during 3 months

CBT treatment of internet dependence plus CBT treatment of sleep disorders during 3 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 11, 2015
Last Updated
May 14, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02390583
Brief Title
Internet Addiction and Sleep Disorders
Acronym
ADDICSOM
Official Title
Internet Addiction and Sleep Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
no patient
Study Start Date
September 2016 (undefined)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Internet Addiction
Keywords
Internet dependence, Sleep disorders, pathological gambling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Active Comparator
Arm Description
CBT treatment of internet dependence each two weeks during 3 months
Arm Title
intervention
Arm Type
Experimental
Arm Description
CBT treatment of internet dependence plus CBT treatment of sleep disorders during 3 months
Intervention Type
Behavioral
Intervention Name(s)
CBT treatment of internet dependence
Intervention Description
CBT treatment of internet dependence
Intervention Type
Behavioral
Intervention Name(s)
CBT treatment of sleep disorders
Intervention Description
CBT treatment of sleep disorders
Primary Outcome Measure Information:
Title
number of hours each week spent gaming or online gambling
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of hours spent on line gaming or online gambling
Time Frame
3 months
Title
insomnia
Description
measure with Insomnia Severity Index (ISI)
Time Frame
3 and 6months
Title
daytime sleepiness
Description
daytime sleepiness with specific scales ( Epworth and KAROLINSKA)
Time Frame
3 and 6 months
Title
total sleep time
Description
total sleep time (actimetry, sleep agenda) Actimetry results will be centrally reviewed by experts blinded to realization date
Time Frame
3 and 6 months
Title
number of awakenings during night
Description
number of awakenings during night (actimetry) Actimetry results will be centrally reviewed by experts blinded to realization date
Time Frame
3 and 6 months
Title
treatment with hypnotics
Description
Number of tablets taken each week
Time Frame
3 and 6 months
Title
Depression
Description
score of depression at the MINI questionnaire
Time Frame
3 and 6 months
Title
Anxiety
Description
Anxiety scores at the MINI questionnaire
Time Frame
3and 6 months
Title
Alcohol dependence
Description
Alcohol dependence assess with severity AUDIT scale
Time Frame
3 and 6 months
Title
Nicotine Dependence
Description
assess with Fagerstrom scale
Time Frame
3 and 6 months
Title
Other psychoactive agents
Description
assess with RDAPS questionnaire
Time Frame
3 and 6 months
Title
Compliance
Description
Compliance will be studied with the participation of patients to CBT groups at 3 and 6 months.
Time Frame
3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lejoyeux Lejoyeux, Professor
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bichat-Claude.Bernard
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Internet Addiction and Sleep Disorders

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