Trial document





This trial has been registered retrospectively.
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  DRKS00005011

Trial Description

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Title

Pathological computer and internetuse- is it an addiction?

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Trial Acronym

Avatar

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Due to the increasing number of people suffering from excessive computer and online use, questions about aetiology and the distinction between normal and pathological computer and internet use have been increased. In order to develop adequate therapies for helping people who suffer from this disorder, it is necessary to investigate psychological, neurobiological and neuropsychological aetiological factors which influence the development and maintenance of this clinical picture.
An epidemiological study based on a telephone survey with 15024 participants between 14 and 64 years of age, identified 1.5% as pathological computer and internet users (Rumpf, Meyer, Kreuzer, & John, 2012). This would correspond to 161.388 citizens in Baden Württemberg. Regarding adolescents in the age between 14 and 24, the prevalence rate of was estimated at 2.4% in Germany. If we look at the younger population in Germany aged 14-24, the rate of ‘dependent’ users stood at 2.4%. The few existing studies on pathological computer and internet use indicate similarities to substance dependent disorders and pathological gambling. Accordingly, studies report a high comorbidity of substance related disorders in individuals affected from problematic computer and internet use (Ko, Yen, Yen, Chen, & Chen, 2012). Furthermore, similar to research findings on substance related disorders and pathological gambling, studies on pathological computer and internet use could show a significant positive association between ‘dependence’ severity and personality characteristics, such as impulsivity, sensation seeking, anxiety as well as deficits in social skills. The few existing investigations about the underling neurobiological mechanisms of pathological computer and internet use also confirm similarities to substance related disorders and pathological gambling in impaired reward sensitivity and inhibitory control functions.
Primary aim of the study is to identify psychpathological and neurobiological mechanisms which could help to clarify the development and maintenance of pathological computer and internet use. In a subsequent step, a psychotherapeutic manual shall be developed in a second step.
According to the study findings on substance related disorders and pathological gambling, the proposed study will focus on the assessment of comorbidity and personality traits (e.g. impulsivity, sensation seeking) and its neurobiological correlates.
Closely related to the issues of personality and social competence, some studies indicate that one reason for this pathological behaviour may be an impairment of self-concept (Bessiere et al., 2007; Smahel et al., 2008). Self-concept is defined as the individual’s perception of his / her skills, interests, desires, emotions, values, actions and physical attractiveness (Deusinger, 1996). The secondary aim of the proposed study is to assess psychological and neurobiological correlates of self-concept. The assessed facets of the self concept are the physical, emotional self concept and self believes. Psychometric as well as fMRI-based tools will be applied.
In order to increase sample representativity and the opportunities for recruiting the study will also involve an online survey, which does a priori does not differentiate between the two groups (i.e. patients and controls).

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Brief Summary in Scientific Language

Due to the increasing number of people suffering from excessive computer and online use, questions about aetiology and the distinction between normal and pathological computer and internet use have been increased. In order to develop adequate therapies for helping people who suffer from this disorder, it is necessary to investigate psychological, neurobiological and neuropsychological aetiological factors which influence the development and maintenance of this clinical picture.
The few existing psychological and neurobiological studies on pathological computer and internet use indicate similarities to substance dependent disorders and pathological gambling. Primary aim of the study is to identify psychpathological and neurobiological mechanisms which could help clarify the development and maintenance of pathological computer and internet use. Closely related to the issues of personality and social competence, some studies indicate that one reason for this pathological behaviour may be an impairment of self-concept (Bessiere et al., 2007; Smahel et al., 2008). The secondary aim of the proposed study is to assess psychological and neurobiological correlates of self-concept. The assessed facets of the self concept are the physical, emotional self concept and self believes.
In order to increase sample representativity and the opportunities for recruiting the study will also involve an online survey.

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Organizational Data

  •   DRKS00005011
  •   2015/03/10
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  •   yes
  •   Approved
  •   2013-528N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   F68.8 -  Other specified disorders of adult personality and behaviour
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Interventions/Observational Groups

  •   Control group: Subjects exhibiting occasional, i.e. non-pathological computer and internet use. First appointment:
    Detailed explanation of study procedures and written informed consent, check that in- and exclusion criteria are fulfilled, demographical data collection, diagnostics: AICA, Comorbidity: SCID I and II, questionnaires for the examination of the self-concept and impulsivity, drug test (urine).
    In case of interest into the fMRI-part of the study: check of in- and exclusion criteria for fMRI, which is conducted at a second measurement time point. In case of consent for the fMRI part, a pregnancy test will be conducted for women. In addition, a fotoshooting and avatar-screenshots are created at the first appointment.

    Second appointment:
    At the second appointment, the fMRI examination as well as questionnaires related to craving and the identification with an avatar are conducted.

    Neuropsychological testing is achieved by means of the CANTAB (affective go no go task); fMRI comprises paradigms involving an emotional stroop task, a self-perception task and a self-reflection task, as well as anatomical scans.
  •   Patientgroup: Subjects exhibiting pathological computer and internet use. For methods see control group above.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Neurobiological and psychological mechanisms of pathologocal computer and internet use.

- Diagnostic: Assessment of Internet and Computergame Addiction (Interview; AICA)
- Comorbidity: SKID I II,

- Body Image: Questionnaire for body-image and attractiveness (FKB-20; Clement & Löwe, 1996)
- Emotional Competence Questionnaire (EKF; Rindermann, 2009)
- Self-worth: Self-worth-scale (Rosenberg Skala; Rosenberg, 1965)
- Attention Deficit Hyperactivity Disorder: Screening instrument for ADHD in aduldhood (ADHS- SB aus (Rösler et al., 2007))
- Symptom Check List (SCL-90; Franke, 2002)
- Depression: Becks Depression Inventory (BDI; Beck, Ward, Mendelson, Mock, & Erbaugh, 1961)
- Nicotine Dependence: Fagerström Test for Nicotine dependence (FTND; Bleich, Havemann-Reinecke, & Kornhuber, 2002)

- Personality Traits: Neo-Five Factor Inventory (Neo-FFI) (Borkenau & Ostendorf, 1993)
- Anxiety: State Trait Anxiety Inventory (STAI) (Spielberger, Gorsuch, & Lushene, 1970)
- Inhibitory control: Baratt Impulsiveness Scale (BIS) (Standford & Barratt, 1992)
- Sensation Seeking: Zuckerman-Sensation-Seeking-Skale V (Zuckerman, 1991; German translation: Beauducel, Strobel & Brocke, 2003)
- Craving and Avatar identification: Questionnaire for Craving and identification with the own Avatar


- Neuropsychological testing for investigation of emotional inhibitory control processing is achieved by means of the CANTAB (affective go no go task);
- fMRI comprises paradigms assessing neurobiological correlates of self-concept and inhibitory control processing involving an emotional stroop task, a self-perception task and a self-reflection task, as well as anatomical scans.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/07/03
  •   800
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   64   Years
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Additional Inclusion Criteria

--Male and female subjects aged 18-64 years
--Pathological computer- and internet users need to exhibit pathological computer- and internet use as main diagnosis. In addition, the criteria for pathological computer- and internet use according to the AICA- (Assessment of Internet and Computer game Addiction; Wölfling et al., 2012) and AICA-S- (Assessment of Internet and Computer game Addiction, Selbstbericht; Wölfling et al., 2011) checklists need to be met with a score of ≥ 7 within the last 6 months.
--Healthy subjects should merely exhibit occasional computer- and internet use.
--Healthy subjects should not to display any Axis I disorder except nicotine dependence or misuse according to ICD-10 and DSM-IV.
­--All participants need to be capable of giving fully informed written consent as well as to complete the self-report questionnaires.
--Written informed consent needs to be given after detailed explanation of study procedures before the start of the examinations.


Additional inclusion criteria for the fMRI examination

--Written informed consent needs to be given after detailed explanation of study procedures prior to the examination.
--Right-handedness

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Exclusion Criteria

--Improper knowledge of German language
--Restricted legal competence or deficient ability to give written informed consent after explanation of the study procedures
­--Deafness of blindness


Additional exclusion criteria for the fMRI examination

--Current or past treatment-requiring psychiatric Axis I disorder (DSM-IV / ICD-10 via SKID I) within the last 12 months:
o Organic disorder, including symptomatic mental disorder (F00 – F09),
o Substance abuse / substance dependence (F1x.x) except nicotine (F17.x),
o Schizophrenia, schizotypic and delusional disorder (F20 – F29),
o Manic episode, moderate or severe depressive episode (F30 – F33),
o Treatment-requiring anxiety-, obsessive-compulsive-, or dissociative disorder (F40 - F42, F44).
­--A history with one or more of the following treatment-requiring psychiatric Axis I disorders (DSM-IV / ICD-10 via SKID I):
o Organic disorder, including symptomatic mental disorder (F00 – F09),
o Schizophrenia, schizotypic and delusional disorder (F20 – F29),
o Bipolar affective disorder (F31).
--History with severe craniocerebral injury or other severe neurologic disorders
­--Pregnancy
--Participants needing medication for another disease, which is risk-causing in the study context
­--Contraindications for MRI examination (presence of metal in the body, cardiac pacemaker, etc.)
­--Positive result of the drug screening (urine)

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Addresses

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    • Zentralinstitut für Seelische GesundheitKlinik für Abhängiges Verhalten und Suchtmedizin
    • Mr.  Prof.  Karl  Mann 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit Klinik für Abhängiges Verhalten und Suchtmedizin
    • Ms.  Dr. Dipl. Psych.  Tagrid  Leménage 
    • J5
    • 68159  Mannheim
    • Germany
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    • Zentralinstitut für Seelische Gesundheit Klinik für Abhängiges Verhalten und Suchtmedizin
    • Ms.  Dr. Dipl. Psych.  Tagrid  Leménager 
    • J5
    • 68159  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Ministerium für Arbeit und Soziales, Familien und Senioren Baden Württemberg
    • Dr.  Thilo  Walker 
    • Schellingstraße 15
    • 70174   Stuttgart
    • Germany
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    • Das Diakonische Werk der Evangelischen Landeskirche in Baden e.V.Referat Sucht
    • Ms.  Martina  Thrän 
    • Vorholzstraße 3
    • 76137  Karlsruhe
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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