Effects of an Internet Use Disorder and Internet Gaming Disorder Early Intervention Program

Mental Disorder Clinical Trial

— PROTECT+  

Official title:

Effects of an Internet Use Disorder and Internet Gaming Disorder Early Intervention Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03582839
• Other study ID #: PH Heidelberg
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 14, 2016
• Est. completion date: April 1, 2019

Study information

• Verified date: June 2018
• Source: Pädagogische Hochschule Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: April 1, 2019
• Est. primary completion date: December 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 19 Years

Eligibility

Inclusion Criteria:

Adolescents aged 9 to 19 years Self-selection

Exclusion Criteria:

Severe comorbid mental health disorder

Related Conditions & MeSH terms

• Disease
• Mental Disorder
• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• PROTECT+
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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pädagogische Hochschule Heidelberg	Heidelberg University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 1 month, 4-months, 12-months
Primary	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.	baseline, 1 month, 4-months, 12-months
Primary	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.	12-months
Secondary	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.	baseline, 1 month, 4-months, 12-months
Secondary	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).	baseline, 1 month, 4-months, 12-months
Secondary	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.	baseline, 1 month, 4-months, 12-months
Secondary	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.	baseline, 1 month, 4-months, 12-months
Secondary	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).	baseline, 1 month, 4-months, 12-months
Secondary	Procrastination	Procrastination is assessed with the German Questionnaire for Procrastination (Allgemeiner Prokrastinationsfragebogen; APROF; Höcker, Engberding & Rist, 2013).	baseline, 1 month, 4-months, 12-months
Secondary	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).	baseline, 1 month, 4-months, 12-months
Secondary	Self-Efficacy	Self- efficacy is rated on the German Self-Efficacy Scale (Skala zu Allgemeinen Selbstwirksamkeitserwartung; SWE; Schwarzer & Jerusalem, 1999).	baseline, 1 month, 4-months, 12-months