Clinical trial NCT02907658: Efficacy of Internet Use Disorder Prevention
Official title: A Randomized Efficacy Trial of a Cognitive-Behavioral Intervention to Prevent Internet Use Disorder Onset in Adolescents: the PROTECT Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Disorders
Keywords: Internet Use Disorder
Internet Gaming Disorder
Cognitive-Behavioral Intervention
Indicated Prevention
Adolescents
Internet Addiction
Lead sponsor: Pädagogische Hochschule Heidelberg
Sponsor class: OTHER
Collaborators: name: Dietmar Hopp Stiftung
First posted: 2016-09-20
Enrollment: 480
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: 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)

Primary outcomes:
measure: Internet Use Disorder 12-months incidence rate (Clinical Interview for DSM-5 Diagnosis)
timeFrame: 12 months
measure: Internet Use Disorder 12-months incidence rate (Self-Report)
timeFrame: 12 months
measure: Changes in Internet Use Disorder prevalence
timeFrame: baseline, 1 month, 4-months, 12-months
Secondary outcomes:
measure: Emotion Regulation
timeFrame: baseline, 1 month, 4-months, 12-months
measure: Depressive Symptoms
timeFrame: baseline, 1 month, 4-months, 12-months
measure: Comorbid emotional, oppositional, antisocial and attention deficit/ hyperactivity disorders
timeFrame: baseline, 1 month, 4-months, 12-months
measure: Anxiety Disorders: Social Anxiety
timeFrame: baseline, 1 month, 4-months, 12-months
measure: Anxiety Disorders: Performance and School Anxiety
timeFrame: baseline, 1 month, 4-months, 12-months
measure: Procrastination
timeFrame: baseline, 1 month, 4-months, 12-months
measure: Social Behavior and Learning Behavior
timeFrame: baseline, 1 month, 4-months, 12-months
measure: Self-Efficacy
timeFrame: baseline, 1 month, 4-months, 12-months
Other outcomes:
Locations:
Study officials:
affiliation: University of Education Heidelberg
name: Katajun Lindenberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.