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Mental DisordersPROTECTNCT02907658

Efficacy of Internet Use Disorder Prevention

A study testing PROTECT intervention group in people with Mental Disorders, run by Pädagogische Hochschule Heidelberg.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Mental Disorders
What is being tested?
PROTECT intervention group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
No sites listed yet
Study dates
Sep 2015to May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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).

Being tested
PROTECT intervention group
Keywords
Internet Use Disorder, Internet Gaming Disorder, Cognitive-Behavioral Intervention, Indicated Prevention, Adolescents, Internet Addiction
Medical subject headings
Mental Disorders, Internet Addiction Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PROTECT intervention groupBehavioural

    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).

Study groups in NCT02907658
Study groupRoleWhat they receive
PROTECT intervention groupExperimentalThe 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).
Receives: Behavioral: PROTECT intervention group
Assessment-only control groupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 12 months

  2. 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).

    Measured: 12 months

  3. 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.

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

Secondary outcomes (8)

  1. 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.

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

  2. Depressive Symptoms

    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).

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

  3. 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) 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.

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

  4. 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) is used. This questionnaire assesses anxiety in social interactions and al-lows for detection and the estimation of severity of social anxiety disorders.

    1. 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).

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

  5. 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).

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

  6. Procrastination

    Procrastination is assessed with the German Questionnaire for Procrastination (APROF; Höcker, Engberding \& Rist, 2013).

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

  7. Social Behavior and Learning Behavior

    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).

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

  8. Self-Efficacy

    Self- efficacy is rated on the German Self-Efficacy Scale (Allgemeine Selbstwirksamkeitserwartung, SWE; Schwarzer \& Jerusalem, 1999).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionApr 2018 (estimated)
  4. Study completionMay 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02907658
Sponsor's protocol ID
PHHD-PROTECT-101030906
Acronym
PROTECT
Status last verified
Sep 2017
First submitted
9 Sep 2016
Last updated
21 Sep 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 35179587

  • 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.

    PubMed 31936677

  • 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.

    PubMed 29740637

  • 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.

    PubMed 29649137

Questions about this trial

What is this clinical trial studying?

A study testing PROTECT intervention group in people with Mental Disorders, run by Pädagogische Hochschule Heidelberg.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Internet Use Disorder 12-months incidence rate (Clinical Interview for DSM-5 Diagnosis) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02907658, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2017.

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