- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01434589
Effects of a Manualized Short-term Treatment of Internet and Computer Game Addiction (STICA)
October 10, 2017 updated by: M.E. Beutel, Johannes Gutenberg University Mainz
The purpose of this study is to 1) determine the efficacy of manualized Short-term Treatment of Internet and Computer game Addiction (STICA), assess 2) the durability of treatment response in these patients and 3) the impact on associated psychiatric symptoms, e.g.
social anxiety and depression.
Study Overview
Study Type
Interventional
Enrollment (Actual)
187
Phase
- 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
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-
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Vienna, Austria, 1230
- Anton Proksch Insitut, Therapy Centre for the Treatment of Addictions
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-
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Mainz, Germany, 55131
- University Medical Center Mainz, Department of Psychosomatic Medicine and Psychotherapy, Outpatient clinic for behavioral addictions
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Mannheim, Germany, 68159
- Central Insitute for Mental Health
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Tübingen, Germany, 72076
- University Medical Center Tübingen
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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
Ages Eligible for Study
15 years to 53 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- clinical diagnosis of internet or computer game addiction
- internet or computer game addiction according to the AICA-Checklist(Assessment of Internet and Computer game addiction, expert Rating)
- a score >/= 7 in the AICA-S (Assessment of Internet and Computer game addiction, Self Rating)
- patients with primary diagnoses of internet or computer game addiction
- if currently on psychotropic medications, no change in medications and dosages in the past 2 months and during STICA treatment
- if currently off all psychotropic medications, patient has been off at least 4 weeks
- at least 4 weeks off from last psychotherapy and no other ongoing psychotherapy
Exclusion Criteria:
- current Global Assessment of Functioning (GAF) < 40
- severe major depression (BDI-II Score >/= 29)
- current alcohol or drug addictions
- personality disorders: borderline, antisocial, schizoid and schizotypal
- lifetime diagnoses of schizophrenia, schizoaffective, bipolar or organic mental disorder
- current unstable medical illness
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 Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Wait list control
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Experimental: STICA Intervention
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Manualized Short-term Treatment for Internet and Computer game Addiction (STICA) based on cognitive behavior-therapy (combining individual and group therapy)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in internet or computer game addiction (self-rating)
Time Frame: 4 and 10 months after randomization
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4 and 10 months after randomization
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change/Remission of internet or computer game addiction (expert rating)
Time Frame: 4 and 10 months after randomization
|
4 and 10 months after randomization
|
Preoccupation with critical internet applications or computer games (hours per week)
Time Frame: 4 and 10 months after randomization
|
4 and 10 months after randomization
|
Improvement of negative consequences (e.g. social communication, psychosocial well being)
Time Frame: 4 and 10 months after randomization
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4 and 10 months after randomization
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Improvement of depressive symptoms (changes in BDI-II)
Time Frame: 4 and 10 months after randomization
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4 and 10 months after randomization
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Improvement of social fear and avoidance (changes in Liebowitz Social Anxiety Scale)
Time Frame: 4 and 10 months after randomization
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4 and 10 months after randomization
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Improvement of Expectances of self-efficacy (Changes in Assessment of Self-Efficacy)
Time Frame: 4 and 10 months after randomization
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4 and 10 months after randomization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: M. E. Beutel, Prof. Dr., University Medical Center Mainz, Department of Psychosomatic Medicine and Psychotherapy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wolfling K, Muller KW, Beutel M. [Reliability and validity of the Scale for the Assessment of Pathological Computer-Gaming (CSV-S)]. Psychother Psychosom Med Psychol. 2011 May;61(5):216-24. doi: 10.1055/s-0030-1263145. Epub 2010 Sep 27. German.
- Wolfling K, Muller KW, Dreier M, Ruckes C, Deuster O, Batra A, Mann K, Musalek M, Schuster A, Lemenager T, Hanke S, Beutel ME. Efficacy of Short-term Treatment of Internet and Computer Game Addiction: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Oct 1;76(10):1018-1025. doi: 10.1001/jamapsychiatry.2019.1676. Erratum In: JAMA Psychiatry. 2019 Sep 4;:
- Jager S, Muller KW, Ruckes C, Wittig T, Batra A, Musalek M, Mann K, Wolfling K, Beutel ME. Effects of a manualized short-term treatment of internet and computer game addiction (STICA): study protocol for a randomized controlled trial. Trials. 2012 Apr 27;13:43. doi: 10.1186/1745-6215-13-43.
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
January 1, 2012
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
September 8, 2011
First Submitted That Met QC Criteria
September 14, 2011
First Posted (Estimate)
September 15, 2011
Study Record Updates
Last Update Posted (Actual)
October 11, 2017
Last Update Submitted That Met QC Criteria
October 10, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BE 2248/10-1
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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