- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03646448
Intervening in Problematic Internet Use (iPIN)
Intervening in Problematic Internet Use - Preventive Measures for Risk Groups
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Lübeck, Germany
- University of Lubeck
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- CIUS score of 21 and at least 2 DSM-criteria
- At least 16 years old
Exclusion Criteria:
- Current treatment for mental disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention group
Counseling based on Motivational Interviewing and elements of Cognitive Behavioral Therapy
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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.
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NO_INTERVENTION: Control group
Control group receiving a booklet on problematic Internet use
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of DSM-5 criteria
Time Frame: Assessment of criteria at baseline and at 6- and 12-month follow ups
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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)
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Assessment of criteria at baseline and at 6- and 12-month follow ups
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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
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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.
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Assessment of time on the Internet at baseline and at 6- and 12-month follow ups
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Change of disabilities caused by the problematic Internet use
Time Frame: Assessment of disabilities at baseline and at 6- and 12-month follow ups
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World Health Organization Disability Assessment Schedule 2.0 (WHODAS) 2.0 (Adapted Version for problematic Internet use):
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Assessment of disabilities at baseline and at 6- and 12-month follow ups
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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
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Negative Consequences-Questionnaire from the Criminological Research Institute of Lower Saxony:
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Assessment of negative consequences at baseline and at 6- and 12-month follow ups
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Readiness to change Internet use
Time Frame: Assessment of readiness to change at baseline and at 6- and 12-month follow ups
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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.
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Assessment of readiness to change at baseline and at 6- and 12-month follow ups
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Self-efficacy to change Internet use
Time Frame: Assessment of self-efficacy at baseline and at 6- and 12-month follow ups
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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.
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Assessment of self-efficacy at baseline and at 6- and 12-month follow ups
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hans-Jürgen Rumpf, PD Dr., University of Lubeck
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1504/68405
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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