Internet Use DisordersiPINNCT03646448
Intervening in Problematic Internet Use
A study testing Motivational Interviewing in people with Internet Use Disorders, run by University of Luebeck at 1 site in Germany.
Trial summary
The present study examines the efficacy of a brief intervention for problematic Internet use based on Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT) in a sample of students screened proactively in vocational schools in Northern Germany. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Internet Use Disorders
- What is being tested?
- Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2017to 31 Mar 2020
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- CIUS score of 21 and at least 2 DSM-criteria
- At least 16 years old
Who cannot join
- Current treatment for mental disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervening in Problematic Internet Use - Preventive Measures for Risk Groups
The present study examines the efficacy of a brief intervention for problematic Internet use based on Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT) in a sample of students screened proactively in vocational schools in Northern Germany. Participants will be randomized in an intervention and a control group. It is hypothesized that after 12 months, participants of the intervention group fulfill less DSM-5 criteria for Internet use disorders, spend less time in the Internet, and suffer from less negative consequences caused by the problematic Internet use, compared to the control group.
Read the detailed description
Problematic Internet use is an increasing problem, especially in younger age groups. A population-based study revealed elevated prevalences in adolescents and young adults. The present study aims to provide an intervention for this vulnerable group to change the problematic Internet use. This is suggested to prevent the development of more severe forms of dependence. Brief interventions using MI and elements of CBT have shown to be an adequate method to change addictive behaviors.
For the recruitment, students of vocational schools in the states of Schleswig-Holstein and Hamburg in Northern Germany are screened proactively in classes. Participants fulfilling at least 21 points on the Compulsive Internet Use Scale (CIUS) receive a diagnostic telephone interview. If fulfilling at least 2 DSM-5 criteria, participants will be randomly allocated to two conditions: (1) Intervention group with up to three telephone counseling sessions based on MI, (2) Control group receiving a booklet on problematic Internet use. Outcome measures are a reduction of DSM-5 criteria for Internet use disorders, a reduction of time spent on the Internet, and a reduction of negative consequences caused by the problematic Internet use. The efficacy of the intervention will be examined after 6 and 12 months in follow-up interviews.
- Conditions
- Internet Use Disorders
- Being tested
- Motivational Interviewing
- Keywords
- Internet Use Disorders, Brief Intervention, Motivational Interviewing, CBT, Proactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Up to three counseling sessions on telephone based on Motivational Interviewing and elements of Cognitive Behavioral Therapy. Counselings are within 12 weeks after the baseline diagnostic interview and follow the stepped care approach.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Counseling based on Motivational Interviewing and elements of Cognitive Behavioral Therapy Receives: Behavioral: Motivational Interviewing |
| Control group | No intervention | Control group receiving a booklet on problematic Internet use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of DSM-5 criteria
Criteria for Internet Use Disorders according to the Internet Gaming Disorder in the DSM-5, but for all Internet Applications are assessed with a diagnostic clinical interview based on the Composite International Diagnostic Interview (CIDI)
Measured: Assessment of criteria at baseline and at 6- and 12-month follow ups
Change of time spent on the Internet
Average time of private Internet use on a weekday and on weekends and maximum use are assessed at baseline and at 6- and 12-month follow ups. Change of time is measured by the difference between the follow up assessments and the baseline.
Measured: Assessment of time on the Internet at baseline and at 6- and 12-month follow ups
Change of disabilities caused by the problematic Internet use
World Health Organization Disability Assessment Schedule 2.0 (WHODAS) 2.0 (Adapted Version for problematic Internet use):
- 4 items ranging from 0 (no impairment) to 10 (strong impairment)
- 2 items estimating the days of impairment in the past 12 months (time frame will be adapted to the time frame in the assessment)
- For change of disabilities, the difference between follow up assessments and baseline will be measured for the single items.
Measured: Assessment of disabilities at baseline and at 6- and 12-month follow ups
Change of negative consequences caused by the problematic Internet use
Negative Consequences-Questionnaire from the Criminological Research Institute of Lower Saxony:
- 8 items ranging from 1 (much worse) to 5 (much better)
- Maximum sum score ranges from 8 to 40
- The questionnaire is inversely coded, so higher outcomes provide a better outcome
- For change of negative consequences, the difference between the sum scores in the follow up assessments and baseline will be measured
Measured: Assessment of negative consequences at baseline and at 6- and 12-month follow ups
Secondary outcomes (2)
Readiness to change Internet use
Readiness to change is measured with a single item ("How important would it be for you to change your Internet use behavior?") on a 10-point-Likert scale (1=not important at all, 10=very important). A higher value represents a better outcome.
Measured: Assessment of readiness to change at baseline and at 6- and 12-month follow ups
Self-efficacy to change Internet use
Self-efficacy is measured with a single item ("How confident are you to change your Internet use behavior?") on a 10-point-Likert scale (1=not confident at all, 10=very confident). A higher value represents a better outcome.
Measured: Assessment of self-efficacy at baseline and at 6- and 12-month follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Oct 2017
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internet Use DisordersStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Ministry of Health, Germany
- Responsible party
- Principal investigator, Hans-Jürgen Rumpf, University of Luebeck
- Investigators
- Hans-Jürgen Rumpf, PD Dr., Principal investigator, University of Lübeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646448
- Sponsor's protocol ID
- 1504/68405
- Acronym
- iPIN
- Status last verified
- Oct 2021
- First submitted
- 20 Mar 2018
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervening in Problematic Internet Use - Preventive Measures for Risk Groups
- ClinicalTrials.gov ID
- NCT03646448
- Acronym / sponsor ID
- iPIN / 1504/68405
- Conditions
- Internet Use Disorders
- Keywords
- Internet Use Disorders, Brief Intervention, Motivational Interviewing, CBT, Proactive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Collaborators
- Federal Ministry of Health, Germany
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 24 Aug 2018 (actual)
- 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.
The present study examines the efficacy of a brief intervention for problematic Internet use based on Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT) in a sample of students screened proactively in vocational schools in Northern Germany. Participants will be randomized in an intervention and a control group. It is hypothesized that after 12 months, participants of the intervention group fulfill less DSM-5 criteria for Internet use disorders, spend less time in the Internet, and suffer from less negative consequences caused by the problematic Internet use, compared to the control group.
Detailed description
Problematic Internet use is an increasing problem, especially in younger age groups. A population-based study revealed elevated prevalences in adolescents and young adults. The present study aims to provide an intervention for this vulnerable group to change the problematic Internet use. This is suggested to prevent the development of more severe forms of dependence. Brief interventions using MI and elements of CBT have shown to be an adequate method to change addictive behaviors.
For the recruitment, students of vocational schools in the states of Schleswig-Holstein and Hamburg in Northern Germany are screened proactively in classes. Participants fulfilling at least 21 points on the Compulsive Internet Use Scale (CIUS) receive a diagnostic telephone interview. If fulfilling at least 2 DSM-5 criteria, participants will be randomly allocated to two conditions: (1) Intervention group with up to three telephone counseling sessions based on MI, (2) Control group receiving a booklet on problematic Internet use. Outcome measures are a reduction of DSM-5 criteria for Internet use disorders, a reduction of time spent on the Internet, and a reduction of negative consequences caused by the problematic Internet use. The efficacy of the intervention will be examined after 6 and 12 months in follow-up interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Motivational InterviewingCounseling based on Motivational Interviewing and elements of Cognitive Behavioral Therapy |
| Control group | No intervention | –Control group receiving a booklet on problematic Internet use |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- CIUS score of 21 and at least 2 DSM-criteria
- At least 16 years old
Key exclusion criteria (1 listed)
- Current treatment for mental disorders
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 |
|---|---|---|
| Motivational InterviewingUp to three counseling sessions on telephone based on Motivational Interviewing and elements of Cognitive Behavioral Therapy. Counselings are within 12 weeks after the baseline diagnostic interview and follow the stepped care approach. | Behavioural | Intervention group |
Primary outcome
Change of DSM-5 criteria
Time frame: Assessment of criteria at baseline and at 6- and 12-month follow ups
Criteria for Internet Use Disorders according to the Internet Gaming Disorder in the DSM-5, but for all Internet Applications are assessed with a diagnostic clinical interview based on the Composite International Diagnostic Interview (CIDI)
Change of time spent on the Internet
Time frame: Assessment of time on the Internet at baseline and at 6- and 12-month follow ups
Average time of private Internet use on a weekday and on weekends and maximum use are assessed at baseline and at 6- and 12-month follow ups. Change of time is measured by the difference between the follow up assessments and the baseline.
Change of disabilities caused by the problematic Internet use
Time frame: Assessment of disabilities at baseline and at 6- and 12-month follow ups
World Health Organization Disability Assessment Schedule 2.0 (WHODAS) 2.0 (Adapted Version for problematic Internet use): * 4 items ranging from 0 (no impairment) to 10 (strong impairment) * 2 items estimating the days of impairment in the past 12 months (time frame will be adapted to the time frame in the assessment) * For change of disabilities, the difference between follow up assessments and baseline will be measured for the single items.
Change of negative consequences caused by the problematic Internet use
Time frame: Assessment of negative consequences at baseline and at 6- and 12-month follow ups
Negative Consequences-Questionnaire from the Criminological Research Institute of Lower Saxony: * 8 items ranging from 1 (much worse) to 5 (much better) * Maximum sum score ranges from 8 to 40 * The questionnaire is inversely coded, so higher outcomes provide a better outcome * For change of negative consequences, the difference between the sum scores in the follow up assessments and baseline will be measured
2 secondary outcomes
Readiness to change Internet use
Time frame: Assessment of readiness to change at baseline and at 6- and 12-month follow ups
Self-efficacy to change Internet use
Time frame: Assessment of self-efficacy at baseline and at 6- and 12-month follow ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
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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.
Hans-Jürgen Rumpf, PD Dr. principal investigator
University of Lübeck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing in people with Internet Use Disorders, run by University of Luebeck at 1 site in Germany.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 18 Oct 2021. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of DSM-5 criteria (time frame: Assessment of criteria at baseline and at 6- and 12-month follow ups). The study lists 4 primary outcomes in all. 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 18 Oct 2021.