ADDICSOM: Internet Addiction and Sleep Disorders

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02390583
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Internet Addiction	Behavioral: CBT treatment of internet dependence; Behavioral: CBT treatment of sleep disorders	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Internet Addiction and Sleep Disorders
• Study Start Date: Sep 1, 2016
• Anticipated Primary Completion Date: Feb 1, 2019
• Anticipated Study Completion Date: Feb 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. number of hours each week spent gaming or online gambling [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

1. Number of hours spent on line gaming or online gambling [3 months]

2. insomnia [3 and 6months]

   measure with Insomnia Severity Index (ISI)

3. daytime sleepiness [3 and 6 months]

   daytime sleepiness with specific scales ( Epworth and KAROLINSKA)

4. total sleep time [3 and 6 months]

   total sleep time (actimetry, sleep agenda) Actimetry results will be centrally reviewed by experts blinded to realization date

5. number of awakenings during night [3 and 6 months]

   number of awakenings during night (actimetry) Actimetry results will be centrally reviewed by experts blinded to realization date

6. treatment with hypnotics [3 and 6 months]

   Number of tablets taken each week

7. Depression [3 and 6 months]

   score of depression at the MINI questionnaire

8. Anxiety [3and 6 months]

   Anxiety scores at the MINI questionnaire

9. Alcohol dependence [3 and 6 months]

   Alcohol dependence assess with severity AUDIT scale

10. Nicotine Dependence [3 and 6 months]

    assess with Fagerstrom scale

11. Other psychoactive agents [3 and 6 months]

    assess with RDAPS questionnaire

12. Compliance [3 and 6 months]

    Compliance will be studied with the participation of patients to CBT groups at 3 and 6 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT02390583
• Other Study ID Numbers: P120140
• First Posted: Mar 17, 2015
• Last Update Posted: May 16, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: Internet dependence; Sleep disorders; pathological gambling
• Additional relevant MeSH terms: Sleep Wake Disorders; Parasomnias; Behavior, Addictive; Internet Addiction Disorder

Study Results

No Results Posted as of May 16, 2017