Efficacy of Internet Use Disorder Prevention

NCT ID: NCT02907658

Last Updated: 2017-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-05-31

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).

Conditions

Mental Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

PROTECT intervention group

Intervention Type: BEHAVIORAL

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).

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PROTECT intervention group

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).

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Accepts Healthy Volunteers: Yes

Sponsors

Dietmar Hopp Stiftung

OTHER

Sponsor Role: collaborator

Pädagogische Hochschule Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katajun Lindenberg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Education Heidelberg

References

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.

Reference Type: DERIVED

PMID: 35179587 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31936677 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29740637 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29649137 (View on PubMed)

Other Identifiers

PHHD-PROTECT-101030906

Identifier Type: -

Identifier Source: org_study_id