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Intervening in Problematic Internet Use (iPIN)

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ClinicalTrials.gov Identifier: NCT03646448
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
Federal Ministry of Health, Germany
Information provided by (Responsible Party):
Hans-Jürgen Rumpf, University of Luebeck

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Internet Use Disorders Behavioral: Motivational Interviewing Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intervening in Problematic Internet Use - Preventive Measures for Risk Groups
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : March 31, 2020

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.

  4. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CIUS score of 21 and at least 2 DSM-criteria
  • At least 16 years old

Exclusion Criteria:

  • Current treatment for mental disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646448


Contacts
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Contact: Hans-Jürgen Rumpf, PD Dr. +4945150098751 hans-juergen.rumpf@uksh.de
Contact: Anja Bischof, PhD +4945150098753 anja.bischof@uksh.de

Locations
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Germany
University of Lübeck Recruiting
Lübeck, Germany
Contact: Anja Bischof, PhD    +4945150098753    anja.bischof@uksh.de   
Contact: Hans-Jürgen Rumpf, PD Dr.    +4945150098751    hans-juergen.rumpf@uksh.de   
Principal Investigator: Hans-Jürgen Rumpf, PD Dr.         
Sponsors and Collaborators
University of Luebeck
Federal Ministry of Health, Germany
Investigators
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Principal Investigator: Hans-Jürgen Rumpf, PD Dr. University of Lübeck

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Responsible Party: Hans-Jürgen Rumpf, Head of Research group S:TEP, University of Luebeck
ClinicalTrials.gov Identifier: NCT03646448     History of Changes
Other Study ID Numbers: 1504/68405
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hans-Jürgen Rumpf, University of Luebeck:
Internet Use Disorders
Brief Intervention
Motivational Interviewing
CBT
Proactive