NCT03646448

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
470

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

2.5 years

First QC Date

March 20, 2018

Last Update Submit

October 15, 2021

Conditions

Keywords

Internet Use DisordersBrief InterventionMotivational InterviewingCBTProactive

Outcome Measures

Primary Outcomes (4)

  • 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)

    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.

    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.

    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

    Assessment of negative consequences at baseline and at 6- and 12-month follow ups

Secondary Outcomes (2)

  • Readiness to change Internet use

    Assessment of readiness to change at baseline and at 6- and 12-month follow ups

  • Self-efficacy to change Internet use

    Assessment of self-efficacy at baseline and at 6- and 12-month follow ups

Study Arms (2)

Intervention group

EXPERIMENTAL

Counseling based on Motivational Interviewing and elements of Cognitive Behavioral Therapy

Behavioral: Motivational Interviewing

Control group

NO INTERVENTION

Control group receiving a booklet on problematic Internet use

Interventions

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.

Intervention group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Current treatment for mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lübeck

Lübeck, Germany

Location

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Hans-Jürgen Rumpf, PD Dr.

    University of Lübeck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research group S:TEP

Study Record Dates

First Submitted

March 20, 2018

First Posted

August 24, 2018

Study Start

October 1, 2017

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

October 18, 2021

Record last verified: 2021-10

Locations