AddictionSTICANCT01434589
Effects of a Manualized Short-term Treatment of Internet and Computer Game Addiction
A study testing STICA Intervention in people with Addiction, run by Johannes Gutenberg University Mainz at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 17 to 55 years, men only
- Conditions the study is for
- Addiction
- What is being tested?
- STICA Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2012to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 55 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
University Medical Center Mainz, Department of Psychosomatic Medicine and Psychotherapy, Outpatient clinic for behavioral addictions
Mainz, 55131
Central Insitute for Mental Health
Mannheim, 68159
University Medical Center Tübingen
Tübingen, 72076
Austria1 site
Anton Proksch Insitut, Therapy Centre for the Treatment of Addictions
Vienna, 1230
About this study
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.
- Conditions
- Addiction
- Being tested
- STICA Intervention
- Keywords
- internet addiction, computer game addiction, STICA, short-term treatment, psychotherapy, internet and computer game addiction
- Medical subject headings
- Behavior, Addictive, Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STICA InterventionBehavioural
Manualized Short-term Treatment for Internet and Computer game Addiction (STICA) based on cognitive behavior-therapy (combining individual and group therapy)
| Study group | Role | What they receive |
|---|---|---|
| Wait list control | No intervention | Not described |
| STICA Intervention | Experimental | Not described Receives: Behavioral: STICA Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in internet or computer game addiction (self-rating)
Measured: 4 and 10 months after randomization
Secondary outcomes (6)
Change/Remission of internet or computer game addiction (expert rating)
Measured: 4 and 10 months after randomization
Preoccupation with critical internet applications or computer games (hours per week)
Measured: 4 and 10 months after randomization
Improvement of negative consequences (e.g. social communication, psychosocial well being)
Measured: 4 and 10 months after randomization
Improvement of depressive symptoms (changes in BDI-II)
Measured: 4 and 10 months after randomization
Improvement of social fear and avoidance (changes in Liebowitz Social Anxiety Scale)
Measured: 4 and 10 months after randomization
Improvement of Expectances of self-efficacy (Changes in Assessment of Self-Efficacy)
Measured: 4 and 10 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startJan 2012
- Primary completionJun 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.E. Beutel, Johannes Gutenberg University Mainz
- Investigators
- M. E. Beutel, Prof. Dr., Principal investigator, University Medical Center Mainz, Department of Psychosomatic Medicine and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434589
- Sponsor's protocol ID
- BE 2248/10-1
- Acronym
- STICA
- Status last verified
- Oct 2017
- First submitted
- 8 Sep 2011
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 20878599Wolfling 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.
PubMed 31290948Jager 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.
PubMed 22540330
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Manualized Short-term Treatment of Internet and Computer Game Addiction
- ClinicalTrials.gov ID
- NCT01434589
- Acronym / sponsor ID
- STICA / BE 2248/10-1
- Conditions
- Addiction
- Keywords
- internet addiction, computer game addiction, STICA, short-term treatment, psychotherapy, internet and computer game addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 15 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait list control | No intervention | – |
| STICA Intervention | Experimental | Behavioral: STICA Intervention |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STICA InterventionManualized Short-term Treatment for Internet and Computer game Addiction (STICA) based on cognitive behavior-therapy (combining individual and group therapy) | Behavioural | STICA Intervention |
Primary outcome
Change in internet or computer game addiction (self-rating)
Time frame: 4 and 10 months after randomization
6 secondary outcomes
Change/Remission of internet or computer game addiction (expert rating)
Time frame: 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
Improvement of negative consequences (e.g. social communication, psychosocial well being)
Time frame: 4 and 10 months after randomization
Improvement of depressive symptoms (changes in BDI-II)
Time frame: 4 and 10 months after randomization
Improvement of social fear and avoidance (changes in Liebowitz Social Anxiety Scale)
Time frame: 4 and 10 months after randomization
Improvement of Expectances of self-efficacy (Changes in Assessment of Self-Efficacy)
Time frame: 4 and 10 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Background: PubMed 20878599Wolfling 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.
- Derived from this study: PubMed 31290948Wolfling 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.
- Derived from this study: PubMed 22540330Jager 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. E. Beutel, Prof. Dr. principal investigator
University Medical Center Mainz, Department of Psychosomatic Medicine and Psychotherapy
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STICA Intervention in people with Addiction, run by Johannes Gutenberg University Mainz at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in internet or computer game addiction (self-rating) (time frame: 4 and 10 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01434589, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.