An interventional study of PROTECT+ in Mental Disorder, sponsored by Pädagogische Hochschule Heidelberg. Status unknown. Open to participants aged 9 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-11.
Sponsored by Pädagogische Hochschule Heidelberg · Not applicable, Interventional, and Treatment
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.
2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.
This study's enrollment of 54 is below the median of 94 across 1,574 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →Pädagogische Hochschule Heidelberg is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Adolescents aged 9 to 19 years Self-selection
Exclusion Criteria:
Severe comorbid mental health disorder
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).
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).
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.
Time frame: baseline, 1 month, 4-months, 12-months
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.
Time frame: baseline, 1 month, 4-months, 12-months
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.
Time frame: 12-months
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.
Time frame: baseline, 1 month, 4-months, 12-months
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).
Time frame: baseline, 1 month, 4-months, 12-months
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.
Time frame: baseline, 1 month, 4-months, 12-months
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.
Time frame: baseline, 1 month, 4-months, 12-months
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).
Time frame: baseline, 1 month, 4-months, 12-months
Procrastination
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
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).
Time frame: baseline, 1 month, 4-months, 12-months
Self-Efficacy
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
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Plan to share: Undecided
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Pädagogische Hochschule Heidelberg