Efficacy of Internet Use Disorder Prevention

NCT02907658 | Unknown

• 1 other identifier: PHHD-PROTECT-101030906
• Study Type: interventional
• Target: 480
• Locations: 0 countries
• Sites: N/A

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

Keywords

Internet Use Disorder; Internet Gaming Disorder; Cognitive-Behavioral Intervention; Indicated Prevention; Adolescents; Internet Addiction

Outcome Measures

Primary Outcomes (3)

• Internet Use Disorder 12-months incidence rate (Clinical Interview for DSM-5 Diagnosis)

  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)

  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

  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 Outcomes (8)

• Emotion Regulation

  baseline, 1 month, 4-months, 12-months

• Depressive Symptoms

  baseline, 1 month, 4-months, 12-months

• Comorbid emotional, oppositional, antisocial and attention deficit/ hyperactivity disorders

  baseline, 1 month, 4-months, 12-months

• Anxiety Disorders: Social Anxiety

  baseline, 1 month, 4-months, 12-months

• Anxiety Disorders: Performance and School Anxiety

  baseline, 1 month, 4-months, 12-months

Study Arms (2)

PROTECT intervention group

EXPERIMENTAL

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).

Behavioral: PROTECT intervention group

Assessment-only control group

NO INTERVENTION

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).

Interventions

PROTECT intervention group 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).

PROTECT intervention group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents aged 12 to 18 years
• Written informed consent
• High-risk for IUD (Screening: CIUS \>= 20)

You may not qualify if:

• Current IUD diagnosis or treatment
• Comorbid depression
• Comorbid anxiety disorder (social phobia or performance anxiety)

Sponsors & Collaborators

• Pädagogische Hochschule Heidelberg: lead
• Dietmar Hopp Stiftung: collaborator

Related Publications (4)

• 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.

  PMID: 35179587 DERIVED

• 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.

  PMID: 31936677 DERIVED

• 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.

  PMID: 29740637 DERIVED

• 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.

  PMID: 29649137 DERIVED

MeSH Terms

Conditions

Mental Disorders; Internet Addiction Disorder

Condition Hierarchy (Ancestors)

Technology Addiction; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Katajun Lindenberg, PhD

  University of Education Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 20, 2016
• Study Start: September 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2018
• Last Updated: September 21, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share