Internet AddictionADDICSOMNCT02390583
Internet Addiction and Sleep Disorders
A study testing CBT treatment of internet dependence and CBT treatment of sleep disorders in people with Internet Addiction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Internet Addiction
- What is being tested?
- CBT treatment of internet dependence and CBT treatment of sleep disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This is an open label randomized controlled trial, comparing two modes of treatment for internet addiction (gaming or gambling online) with sleep disorders associated.
Read the 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).
- Conditions
- Internet Addiction
- Being tested
- CBT treatment of internet dependence, CBT treatment of sleep disorders
- Keywords
- Internet dependence, Sleep disorders, pathological gambling
- Medical subject headings
- Internet Addiction Disorder, Sleep Wake Disorders, Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT treatment of internet dependenceBehavioural
CBT treatment of internet dependence
CBT treatment of sleep disordersBehavioural
CBT treatment of sleep disorders
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | CBT treatment of internet dependence each two weeks during 3 months Receives: Behavioral: CBT treatment of internet dependence |
| intervention | Experimental | CBT treatment of internet dependence plus CBT treatment of sleep disorders during 3 months Receives: Behavioral: CBT treatment of internet dependence; Behavioral: CBT treatment of sleep disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (12)
Number of hours spent on line gaming or online gambling
Measured: 3 months
insomnia
measure with Insomnia Severity Index (ISI)
Measured: 3 and 6months
daytime sleepiness
daytime sleepiness with specific scales ( Epworth and KAROLINSKA)
Measured: 3 and 6 months
total sleep time
total sleep time (actimetry, sleep agenda) Actimetry results will be centrally reviewed by experts blinded to realization date
Measured: 3 and 6 months
number of awakenings during night
number of awakenings during night (actimetry) Actimetry results will be centrally reviewed by experts blinded to realization date
Measured: 3 and 6 months
treatment with hypnotics
Number of tablets taken each week
Measured: 3 and 6 months
Depression
score of depression at the MINI questionnaire
Measured: 3 and 6 months
Anxiety
Anxiety scores at the MINI questionnaire
Measured: 3and 6 months
Alcohol dependence
Alcohol dependence assess with severity AUDIT scale
Measured: 3 and 6 months
Nicotine Dependence
assess with Fagerstrom scale
Measured: 3 and 6 months
Other psychoactive agents
assess with RDAPS questionnaire
Measured: 3 and 6 months
Compliance
Compliance will be studied with the participation of patients to CBT groups at 3 and 6 months.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startSep 2016
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Why it stopped: no patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internet AddictionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lejoyeux Lejoyeux, Professor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390583
- Sponsor's protocol ID
- P120140
- Acronym
- ADDICSOM
- Status last verified
- Apr 2017
- First submitted
- 11 Mar 2015
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: At the end of the study, patient could be informed of result of the study if they wish. No individual result will be communicate.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Addiction and Sleep Disorders
- ClinicalTrials.gov ID
- NCT02390583
- Acronym / sponsor ID
- ADDICSOM / P120140
- Conditions
- Internet Addiction
- Keywords
- Internet dependence, Sleep disorders, pathological gambling
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patient
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Behavioral: CBT treatment of internet dependenceCBT treatment of internet dependence each two weeks during 3 months |
| intervention | Experimental | Behavioral: CBT treatment of internet dependence, Behavioral: CBT treatment of sleep disordersCBT treatment of internet dependence plus CBT treatment of sleep disorders during 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT treatment of internet dependenceCBT treatment of internet dependence | Behavioural | control, intervention |
| CBT treatment of sleep disordersCBT treatment of sleep disorders | Behavioural | intervention |
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.
12 secondary outcomes
Number of hours spent on line gaming or online gambling
Time frame: 3 months
insomnia
Time frame: 3 and 6months
daytime sleepiness
Time frame: 3 and 6 months
total sleep time
Time frame: 3 and 6 months
number of awakenings during night
Time frame: 3 and 6 months
treatment with hypnotics
Time frame: 3 and 6 months
Depression
Time frame: 3 and 6 months
Anxiety
Time frame: 3and 6 months
Alcohol dependence
Time frame: 3 and 6 months
Nicotine Dependence
Time frame: 3 and 6 months
Other psychoactive agents
Time frame: 3 and 6 months
Compliance
Time frame: 3 and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Individual participant dataSharing planned: No. At the end of the study, patient could be informed of result of the study if they wish. No individual result will be communicate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lejoyeux Lejoyeux, Professor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT treatment of internet dependence and CBT treatment of sleep disorders in people with Internet Addiction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of hours each week spent gaming or online gambling (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.