Effects of an Internet Use Disorder and Internet Gaming Disorder Early Intervention Program (PROTECT+)
Primary Purpose
Mental Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PROTECT+
Sponsored by
About this trial
This is an interventional treatment trial for Mental Disorder
Eligibility Criteria
Inclusion Criteria:
Adolescents aged 9 to 19 years Self-selection
Exclusion Criteria:
Severe comorbid mental health disorder
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PROTECT+
Arm Description
The PROTECT+ intervention group is a self-selected sample, which receives the PROTECT+ group therapy (4 modules in 4 subsequent weeks à 100 min). Participants are assessed at T1 (baseline), T2 (post treatment, 1-month follow-up), T3 (4-months follow-up), and T4 (12-months follow-up).
Outcomes
Primary Outcome Measures
Changes in IUD symptom severity (self-report)
IUD symptom severity is assessed by the Compulsive Internet Use Scale (CIUS; Meerkerk, Van Den Eijnden, Vermulst & Garretsen, 2009). The CIUS is a broadly used and validated questionnaire including 14 Items assessing IUD.
Changes in (I)GD/IUD symptom severity (self-report and parental report)
(I)GD/IUD symptom severity is assessed via self-reports and via parental reports by the Video Game Dependency Scale (Computerspielabhängigkeitsskala; CSAS; Rehbein, Baier, Kleimann & Mößle, 2015). The CSAS questionnaire has been adapted by including non-gaming IU.
Changes in (I)GD/IUD symptom severity (Clinical Interview based on DSM-5)
At 12-months follow-up, we conduct a clinical interview based on the criteria of IGD according to the DSM-5. We adapted the criteria by non-gaming subtypes to assess IUD.
Secondary Outcome Measures
Emotion Regulation
For the measurement of emotion regulation the German Questionnaire for Assessment of Emotion Regulation in Children and Adolescents (Fragebogen zur Erhebung der Emotionsregulation bei Kindern und Jugendlichen; FEEL-KJ; Grob & Smolenski, 2011) is used. The questionnaire includes a measure of functional and dysfunctional emotion regulation strategies for the negative emotions fear, sadness and anger.
Depressive Symptoms
Depressive symptoms are assessed using the German Depression Inventory for Children and Adolescents (Depressionsinventar für Kinder und Jugendliche; DIKJ; Stiensmeier-Pelster, Braune-Krickau, Schürmann & Duda, 2014; Stiensmeier-Pelster, Schürmann & Duda, 1989). The instrument allows for the detection and estimation of severity of depressive disorders according to the DSM-5 criteria (American Psychiatric Association, 2013).
Comorbid emotional, oppositional, antisocial and attention deficit/ hyperactivity disorders
Comorbid Psychopathology is assessed using the Strength and Difficulties Questionnaire (SDQ; Goodman, Meltzer & Bailey, 2003).
It includes the 5 scales (1) emotional problems, (2) behavior problems, (3) hyperactivity/ attention deficits, (4) interpersonal problems with peers and (5) prosocial behavior and can be used for epidemiological research and as an indicator for emotional, oppositional, antisocial and attention deficit/ hyperactivity disorder. The Total Difficulties Score of the SDQ indicates the risk for developing a mental health disorder.
Anxiety Disorders: Social Anxiety
We assess social anxiety using the German version of the Social Interaction Anxiety Scale (SIAS; Mattick & Clarke, 1998; Stangier, Heidenreich, Berardi, Golbs & Hoyer, 1999). This questionnaire assesses anxiety in social interactions and allows for detection and the estimation of severity of social anxiety disorders.
Anxiety Disorders: Performance and School Anxiety
We assess performance and school anxiety with the 7th scale of the German adaption of the Fear Survey Schedule for Children - Revised (Phobiefragebogen für Kinder und Jugendliche; PHOKI Döpfner, Schnabel, Goletz & Ollendick, 2006; Muris & Ollendick, 2002).
Procrastination
Procrastination is assessed with the German Questionnaire for Procrastination (Allgemeiner Prokrastinationsfragebogen; APROF; Höcker, Engberding & Rist, 2013).
Social Behavior and Learning Behavior
For ratings of social competent behavior and academic motivation, we use the German Student Assessment List for Social and Learning Behavior (Schülereinschätzliste für Sozial- und Lernverhalten; SSL; Petermann & Petermann, 2014; Petermann, Petermann & Lohbeck, 2014).
Self-Efficacy
Self- efficacy is rated on the German Self-Efficacy Scale (Skala zu Allgemeinen Selbstwirksamkeitserwartung; SWE; Schwarzer & Jerusalem, 1999).
Full Information
NCT ID
NCT03582839
First Posted
June 4, 2018
Last Updated
June 27, 2018
Sponsor
Pädagogische Hochschule Heidelberg
Collaborators
Heidelberg University
1. Study Identification
Unique Protocol Identification Number
NCT03582839
Brief Title
Effects of an Internet Use Disorder and Internet Gaming Disorder Early Intervention Program
Acronym
PROTECT+
Official Title
Effects of an Internet Use Disorder and Internet Gaming Disorder Early Intervention Program
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 14, 2016 (Actual)
Primary Completion Date
December 23, 2018 (Anticipated)
Study Completion Date
April 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pädagogische Hochschule Heidelberg
Collaborators
Heidelberg University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background. In the last two decades Internet usage has grown vastly. Pathological Internet usage (IUD; Internet Use Disorder) is associated with severe mental health problems affecting social, academic and daily life functioning. Internet Gaming Disorder (IGD) has been already included in the DSM-V. Recently, the WHO declared to include Gaming Disorder (GD) in the upcoming ICD-11. Despite the increasing rates of adolescents with IUD and (I)GD, affected people are treated unsystematically and there is a lack of evidence based treatment programs. PROTECT+ is a low-threshold, cognitive behavioral short-term group intervention.
Methods. 54 patients, aged 9-19 years, received PROTECT+ intervention in Heidelberg, Germany. The PROTECT+ intervention group underwent a cognitive-behavioral 4-session group therapy. Follow-up data were collected at 1, 4, and 12 months after admission. Primary outcome was the change in (I)GD and IUD related symptoms at the 12-months follow-up. Secondary outcomes were changes in comorbid symptoms as well as in problem solving, cognitive restructuring and emotion regulation skills
Discussion. Treatment of IUD and IGD is still in its early stages. Recent reviews report increasing research on treatment but also a lack of well-designed studies and evidence based treatment programs. The PROTECT+ intervention is a theory driven and evidence based therapy program which is based on the PROTECT preventive intervention in school settings. In the intervention group a reduction of (I)GD and IUD symptom severity is expected over 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PROTECT+
Arm Type
Experimental
Arm Description
The PROTECT+ intervention group is a self-selected sample, which receives the PROTECT+ group therapy (4 modules in 4 subsequent weeks à 100 min). Participants are assessed at T1 (baseline), T2 (post treatment, 1-month follow-up), T3 (4-months follow-up), and T4 (12-months follow-up).
Intervention Type
Behavioral
Intervention Name(s)
PROTECT+
Intervention Description
The early intervention PROTECT+ consists of a cognitive-behavioral 4-session brief-protocol (100 minutes) and targets empirically identified risk factors of (I)GD/IUD, i.e. (1) boredom and motivational problems, (2) procrastination and performance anxiety, (3) social behavior and (4) emotion regulation. It addresses both risk-reduction and strength-promotion by cognitive behavioral (CB) interventions such as (1) psychoeducation, (2) cognitive restructuring (identification and modification of dysfunctional cognition), (3) behavior modification (improving problem solving skills, training of functional behavior and reinforcement) as well as (4) improving emotion regulation (training of sensory, imaginative and mindfulness based techniques).
Primary Outcome Measure Information:
Title
Changes in IUD symptom severity (self-report)
Description
IUD symptom severity is assessed by the Compulsive Internet Use Scale (CIUS; Meerkerk, Van Den Eijnden, Vermulst & Garretsen, 2009). The CIUS is a broadly used and validated questionnaire including 14 Items assessing IUD.
Time Frame
baseline, 1 month, 4-months, 12-months
Title
Changes in (I)GD/IUD symptom severity (self-report and parental report)
Description
(I)GD/IUD symptom severity is assessed via self-reports and via parental reports by the Video Game Dependency Scale (Computerspielabhängigkeitsskala; CSAS; Rehbein, Baier, Kleimann & Mößle, 2015). The CSAS questionnaire has been adapted by including non-gaming IU.
Time Frame
baseline, 1 month, 4-months, 12-months
Title
Changes in (I)GD/IUD symptom severity (Clinical Interview based on DSM-5)
Description
At 12-months follow-up, we conduct a clinical interview based on the criteria of IGD according to the DSM-5. We adapted the criteria by non-gaming subtypes to assess IUD.
Time Frame
12-months
Secondary Outcome Measure Information:
Title
Emotion Regulation
Description
For the measurement of emotion regulation the German Questionnaire for Assessment of Emotion Regulation in Children and Adolescents (Fragebogen zur Erhebung der Emotionsregulation bei Kindern und Jugendlichen; FEEL-KJ; Grob & Smolenski, 2011) is used. The questionnaire includes a measure of functional and dysfunctional emotion regulation strategies for the negative emotions fear, sadness and anger.
Time Frame
baseline, 1 month, 4-months, 12-months
Title
Depressive Symptoms
Description
Depressive symptoms are assessed using the German Depression Inventory for Children and Adolescents (Depressionsinventar für Kinder und Jugendliche; DIKJ; Stiensmeier-Pelster, Braune-Krickau, Schürmann & Duda, 2014; Stiensmeier-Pelster, Schürmann & Duda, 1989). The instrument allows for the detection and estimation of severity of depressive disorders according to the DSM-5 criteria (American Psychiatric Association, 2013).
Time Frame
baseline, 1 month, 4-months, 12-months
Title
Comorbid emotional, oppositional, antisocial and attention deficit/ hyperactivity disorders
Description
Comorbid Psychopathology is assessed using the Strength and Difficulties Questionnaire (SDQ; Goodman, Meltzer & Bailey, 2003).
It includes the 5 scales (1) emotional problems, (2) behavior problems, (3) hyperactivity/ attention deficits, (4) interpersonal problems with peers and (5) prosocial behavior and can be used for epidemiological research and as an indicator for emotional, oppositional, antisocial and attention deficit/ hyperactivity disorder. The Total Difficulties Score of the SDQ indicates the risk for developing a mental health disorder.
Time Frame
baseline, 1 month, 4-months, 12-months
Title
Anxiety Disorders: Social Anxiety
Description
We assess social anxiety using the German version of the Social Interaction Anxiety Scale (SIAS; Mattick & Clarke, 1998; Stangier, Heidenreich, Berardi, Golbs & Hoyer, 1999). This questionnaire assesses anxiety in social interactions and allows for detection and the estimation of severity of social anxiety disorders.
Time Frame
baseline, 1 month, 4-months, 12-months
Title
Anxiety Disorders: Performance and School Anxiety
Description
We assess performance and school anxiety with the 7th scale of the German adaption of the Fear Survey Schedule for Children - Revised (Phobiefragebogen für Kinder und Jugendliche; PHOKI Döpfner, Schnabel, Goletz & Ollendick, 2006; Muris & Ollendick, 2002).
Time Frame
baseline, 1 month, 4-months, 12-months
Title
Procrastination
Description
Procrastination is assessed with the German Questionnaire for Procrastination (Allgemeiner Prokrastinationsfragebogen; APROF; Höcker, Engberding & Rist, 2013).
Time Frame
baseline, 1 month, 4-months, 12-months
Title
Social Behavior and Learning Behavior
Description
For ratings of social competent behavior and academic motivation, we use the German Student Assessment List for Social and Learning Behavior (Schülereinschätzliste für Sozial- und Lernverhalten; SSL; Petermann & Petermann, 2014; Petermann, Petermann & Lohbeck, 2014).
Time Frame
baseline, 1 month, 4-months, 12-months
Title
Self-Efficacy
Description
Self- efficacy is rated on the German Self-Efficacy Scale (Skala zu Allgemeinen Selbstwirksamkeitserwartung; SWE; Schwarzer & Jerusalem, 1999).
Time Frame
baseline, 1 month, 4-months, 12-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adolescents aged 9 to 19 years Self-selection
Exclusion Criteria:
Severe comorbid mental health disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katajun Lindenberg, PhD
Organizational Affiliation
Institut für Psychologie der Pädagogischen Hochschule Heidelberg
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33216013
Citation
Szasz-Janocha C, Vonderlin E, Lindenberg K. Treatment outcomes of a CBT-based group intervention for adolescents with Internet use disorders. J Behav Addict. 2020 Nov 16;9(4):978-989. doi: 10.1556/2006.2020.00089.
Results Reference
derived
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Effects of an Internet Use Disorder and Internet Gaming Disorder Early Intervention Program
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