- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02907658
Efficacy of Internet Use Disorder Prevention (PROTECT)
A Randomized Efficacy Trial of a Cognitive-Behavioral Intervention to Prevent Internet Use Disorder Onset in Adolescents: the PROTECT Study
Background. The reduction of prevalence rates of Internet Use Disorder (IUD) and its effective treatment are at high priority in both public health and educational policies. School-based preventive interventions facilitate a low-threshold approach for individuals with IUD, who are typically characterized by high therapy avoidance. Moreover, indicated approaches which target adolescents at high-risk show larger effects than universal prevention approaches. Simultaneously, they reduce unnecessary burden for the majority of high-school students that is not at-risk. The PROTECT intervention for indicated prevention of IUD in school settings was developed based on these preventive strategies.
Methods. Three-hundred and forty adolescents, aged 12-18 years, from 40 secondary schools in Germany, screened for high-risk of IUD onset, will be randomly assigned to a) PROTECT intervention group or b) assessment only control group. The tested intervention consists of a cognitive-behavioral 4-session brief-protocol. Follow-up assessments are at 1, 4 and 12 months after admission. Primary outcome is the 12-months incidence rate of IUD. Secondary outcomes are the reduction of IUD and comorbid symptoms and the promotion of problem solving, cognitive restructuring and emotion regulation skills.
Discussion. The indicated preventive intervention PROTECT follows the APA-guidelines for psychological prevention. It is theory- and evidence-based (guideline 1) and addresses both risk-reduction and strength-promotion (guideline 3), it considers current research and epidemiology (guideline 4) and ethical standards (guideline 5) such as professional secrecy and is designed as a systemic intervention (guideline 8) at the school-level. It is expected that the intervention decreases risk of IUD onset (incidence rate).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescents aged 12 to 18 years
- Written informed consent
- High-risk for IUD (Screening: CIUS >= 20)
Exclusion Criteria:
- Current IUD diagnosis or treatment
- Comorbid depression
- Comorbid anxiety disorder (social phobia or performance anxiety)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PROTECT intervention group
The PROTECT intervention group receives the preventive intervention PROTECT (4 modules in 4 subsequent weeks à 90 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).
|
The indicated preventive intervention PROTECT consists of a cognitive-behavioral 4-session brief-protocol (90 minutes).
It targets empirically identified risk factors of Internet Use Disorder (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).
|
No Intervention: Assessment-only control group
The assessment-only control group is an observational condition without intervention.
Participants are assessed at T1 (baseline), T2 (1-month follow-up), T3 (4-months follow-up), and T4 (12-months follow-up).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Internet Use Disorder 12-months incidence rate (Clinical Interview for DSM-5 Diagnosis)
Time Frame: 12 months
|
We use a clinical interview (blinded rater) based on the criteria of Internet Gaming Disorder according to the DSM-5 at the 12-month follow-up.
We adapted the criteria to assess IUD (including gaming and non-gaming subtypes).
|
12 months
|
Internet Use Disorder 12-months incidence rate (Self-Report)
Time Frame: 12 months
|
We use the German "Computerspielabhängigkeitsskala" (CSAS; Rehbein, Baier, Kleimann & Mößle, 2015), a self-report questionnaire which assesses DSM-5 criteria for Internet Gaming Disorder proposed in DSM-5 section 3 (American Psychiatric Association, 2013): (1) preoccupation, (2) withdrawal, (3) tolerance, (4) unsuccessful attempts to control, (5) loss of interest in other activities, (6) continued excessive use despite problems, (7) deception (8) maladaptive coping, (9) loss of relationship, job, or educational or career opportunities.
We adapted the criteria to assess IUD (including gaming and non-gaming subtypes).
|
12 months
|
Changes in Internet Use Disorder prevalence
Time Frame: baseline, 1 month, 4-months, 12-months
|
To measure the IUD prevalence rate over time (at baseline, 1 month, 4-months, 12-months), we use the adapted version of the CSAS questionnaire.
|
baseline, 1 month, 4-months, 12-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emotion Regulation
Time Frame: baseline, 1 month, 4-months, 12-months
|
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
|
Depressive Symptoms
Time Frame: baseline, 1 month, 4-months, 12-months
|
Depressive symptoms are assessed using the German Depression Inventory for Children and Adolescents (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
|
Comorbid emotional, oppositional, antisocial and attention deficit/ hyperactivity disorders
Time Frame: baseline, 1 month, 4-months, 12-months
|
Comorbid Psychopathology is assessed using the Strength and Difficulties Questionnaire (SDQ; Goodman, Meltzer & Bailey, 2003). It includes the 5 scales (1) emotional problems, (2) behaviour problems, (3) hyperactivity/ attention deficits, (4) interpersonal problems with peers and (5) prosocial behaviour and can be used for epidemiological research and as an indicator for emotional, oppositional, antisocial and attention deficit/ hyperactivity disorder. |
baseline, 1 month, 4-months, 12-months
|
Anxiety Disorders: Social Anxiety
Time Frame: baseline, 1 month, 4-months, 12-months
|
We assess social anxiety using the German version of the Social Interaction Anxiety Scale (SIAS; Mattick & Clarke, 1998; Stangier, Heidenreich, Berardi, Golbs & Hoyer, 1999) is used. This questionnaire assesses anxiety in social interactions and al-lows for detection and the estimation of severity of social anxiety disorders. 2) Performance and school anxiety are assessed 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
|
Anxiety Disorders: Performance and School Anxiety
Time Frame: baseline, 1 month, 4-months, 12-months
|
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
|
Procrastination
Time Frame: baseline, 1 month, 4-months, 12-months
|
Procrastination is assessed with the German Questionnaire for Procrastination (APROF; Höcker, Engberding & Rist, 2013).
|
baseline, 1 month, 4-months, 12-months
|
Social Behavior and Learning Behavior
Time Frame: baseline, 1 month, 4-months, 12-months
|
For ratings of social competent behaviour and academic motivation, we use the German Student Assessment List for Social and Learning Behaviour (SSL; Petermann & Petermann, 2014; Petermann, Petermann & Lohbeck, 2014).
|
baseline, 1 month, 4-months, 12-months
|
Self-Efficacy
Time Frame: baseline, 1 month, 4-months, 12-months
|
Self- efficacy is rated on the German Self-Efficacy Scale (Allgemeine Selbstwirksamkeitserwartung, SWE; Schwarzer & Jerusalem, 1999).
|
baseline, 1 month, 4-months, 12-months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Katajun Lindenberg, PhD, University of Education Heidelberg
Publications and helpful links
General Publications
- Lindenberg K, Kindt S, Szasz-Janocha C. Effectiveness of Cognitive Behavioral Therapy-Based Intervention in Preventing Gaming Disorder and Unspecified Internet Use Disorder in Adolescents: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2148995. doi: 10.1001/jamanetworkopen.2021.48995.
- Wartberg L, Lindenberg K. Predictors of Spontaneous Remission of Problematic Internet Use in Adolescence: A One-Year Follow-Up Study. Int J Environ Res Public Health. 2020 Jan 9;17(2):448. doi: 10.3390/ijerph17020448.
- Lindenberg K, Halasy K, Szasz-Janocha C, Wartberg L. A Phenotype Classification of Internet Use Disorder in a Large-Scale High-School Study. Int J Environ Res Public Health. 2018 Apr 12;15(4):733. doi: 10.3390/ijerph15040733.
- Lindenberg K, Halasy K, Schoenmaekers S. A randomized efficacy trial of a cognitive-behavioral group intervention to prevent Internet Use Disorder onset in adolescents: The PROTECT study protocol. Contemp Clin Trials Commun. 2017 Mar 29;6:64-71. doi: 10.1016/j.conctc.2017.02.011. eCollection 2017 Jun.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHHD-PROTECT-101030906
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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