NCT02390583

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

May 16, 2017

Status Verified

April 1, 2017

Enrollment Period

2.4 years

First QC Date

March 11, 2015

Last Update Submit

May 14, 2017

Conditions

Internet Addiction

Keywords

Internet dependenceSleep disorderspathological gambling

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Number of hours spent on line gaming or online gambling

    3 months

  • insomnia

    3 and 6months

  • daytime sleepiness

    3 and 6 months

  • total sleep time

    3 and 6 months

  • number of awakenings during night

    3 and 6 months

  • +7 more secondary outcomes

Study Arms (2)

control

ACTIVE COMPARATOR

CBT treatment of internet dependence each two weeks during 3 months

Behavioral: CBT treatment of internet dependence

intervention

EXPERIMENTAL

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

Behavioral: CBT treatment of internet dependenceBehavioral: CBT treatment of sleep disorders

Interventions

CBT treatment of internet dependenceBEHAVIORAL

CBT treatment of internet dependence

controlintervention
CBT treatment of sleep disordersBEHAVIORAL

CBT treatment of sleep disorders

intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bichat-Claude.Bernard

Paris, 75018, France

Location

MeSH Terms

Conditions

Internet Addiction DisorderSleep Wake DisordersGambling

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersRisk-TakingDisruptive, Impulse Control, and Conduct Disorders

Study Officials

  • Lejoyeux Lejoyeux, Professor

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2015

First Posted

March 17, 2015

Study Start

September 1, 2016

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

May 16, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

At the end of the study, patient could be informed of result of the study if they wish. No individual result will be communicate.

Locations

FR(1)