Intervening in Problematic Internet Use (iPIN)

October 15, 2021 updated by: Hans-Jürgen Rumpf, University of Luebeck

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
470

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Lübeck, Germany
        • University of Lubeck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention group
Counseling based on Motivational Interviewing and elements of Cognitive Behavioral Therapy
Behavioral: Motivational Interviewing
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.
NO_INTERVENTION: Control group
Control group receiving a booklet on problematic Internet use

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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)
Assessment of criteria at baseline and at 6- and 12-month follow ups
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.
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
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.
Assessment of disabilities at baseline and at 6- and 12-month follow ups
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
Assessment of negative consequences at baseline and at 6- and 12-month follow ups

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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.
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
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.
Assessment of self-efficacy at baseline and at 6- and 12-month follow ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Luebeck

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Federal Ministry of Health, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hans-Jürgen Rumpf, PD Dr., University of Lubeck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1504/68405

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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