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Mental DisorderPROTECT+NCT03582839

Effects of an Internet Use Disorder and Internet Gaming Disorder Early Intervention Program

A study testing PROTECT+ in people with Mental Disorder, 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 The sponsor has not verified this record for over two years, so it may be out of date.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. In the last two decades Internet usage has grown vastly. Pathological Internet usage (IUD; Internet Use Disorder) is associated with severe mental health problems affecting social, academic and daily life functioning. Internet Gaming Disorder (IGD) has been already included in the DSM-V. Read more about this study

Who is it for?
Ages 9 to 19 yearsHealthy volunteers can take part
Conditions the study is for
Mental Disorder
What is being tested?
PROTECT+
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
No sites listed yet
Study dates
14 Apr 2016to 1 Apr 2019
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 9 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Adolescents aged 9 to 19 years Self-selection

Who cannot join

  • Severe comorbid mental health disorder

About this study

Background. In the last two decades Internet usage has grown vastly. Pathological Internet usage (IUD; Internet Use Disorder) is associated with severe mental health problems affecting social, academic and daily life functioning. Internet Gaming Disorder (IGD) has been already included in the DSM-V. Recently, the WHO declared to include Gaming Disorder (GD) in the upcoming ICD-11. Despite the increasing rates of adolescents with IUD and (I)GD, affected people are treated unsystematically and there is a lack of evidence based treatment programs. PROTECT+ is a low-threshold, cognitive behavioral short-term group intervention.

Methods. 54 patients, aged 9-19 years, received PROTECT+ intervention in Heidelberg, Germany. The PROTECT+ intervention group underwent a cognitive-behavioral 4-session group therapy. Follow-up data were collected at 1, 4, and 12 months after admission. Primary outcome was the change in (I)GD and IUD related symptoms at the 12-months follow-up. Secondary outcomes were changes in comorbid symptoms as well as in problem solving, cognitive restructuring and emotion regulation skills

Discussion. Treatment of IUD and IGD is still in its early stages. Recent reviews report increasing research on treatment but also a lack of well-designed studies and evidence based treatment programs. The PROTECT+ intervention is a theory driven and evidence based therapy program which is based on the PROTECT preventive intervention in school settings. In the intervention group a reduction of (I)GD and IUD symptom severity is expected over 12 months.

Conditions
Mental Disorder
Being tested
PROTECT+
Medical subject headings
Mental Disorders

What participants receive

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

  • PROTECT+Behavioural

    The early intervention PROTECT+ consists of a cognitive-behavioral 4-session brief-protocol (100 minutes) and targets empirically identified risk factors of (I)GD/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 NCT03582839
Study groupRoleWhat they receive
PROTECT+ExperimentalThe PROTECT+ intervention group is a self-selected sample, which receives the PROTECT+ group therapy (4 modules in 4 subsequent weeks à 100 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+

What is being measured

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

  1. Changes in IUD symptom severity (self-report)

    IUD symptom severity is assessed by the Compulsive Internet Use Scale (CIUS; Meerkerk, Van Den Eijnden, Vermulst \& Garretsen, 2009). The CIUS is a broadly used and validated questionnaire including 14 Items assessing IUD.

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

  2. Changes in (I)GD/IUD symptom severity (self-report and parental report)

    (I)GD/IUD symptom severity is assessed via self-reports and via parental reports by the Video Game Dependency Scale (Computerspielabhängigkeitsskala; CSAS; Rehbein, Baier, Kleimann \& Mößle, 2015). The CSAS questionnaire has been adapted by including non-gaming IU.

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

  3. Changes in (I)GD/IUD symptom severity (Clinical Interview based on DSM-5)

    At 12-months follow-up, we conduct a clinical interview based on the criteria of IGD according to the DSM-5. We adapted the criteria by non-gaming subtypes to assess IUD.

    Measured: 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 (Depressionsinventar für Kinder und Jugendliche; 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) behavior problems, (3) hyperactivity/ attention deficits, (4) interpersonal problems with peers and (5) prosocial behavior and can be used for epidemiological research and as an indicator for emotional, oppositional, antisocial and attention deficit/ hyperactivity disorder. The Total Difficulties Score of the SDQ indicates the risk for developing a mental health 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). This questionnaire assesses anxiety in social interactions and allows for detection and the estimation of severity of social anxiety disorders.

    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 (Allgemeiner Prokrastinationsfragebogen; APROF; Höcker, Engberding \& Rist, 2013).

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

  7. Social Behavior and Learning Behavior

    For ratings of social competent behavior and academic motivation, we use the German Student Assessment List for Social and Learning Behavior (Schülereinschätzliste für Sozial- und Lernverhalten; 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 (Skala zu Allgemeinen 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 posted11 Jul 2018
  2. Study start14 Apr 2016
  3. Primary completion23 Dec 2018 (estimated)
  4. Study completion1 Apr 2019 (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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03582839
Sponsor's protocol ID
PH Heidelberg
Acronym
PROTECT+
Status last verified
Jun 2018
First submitted
4 Jun 2018
Last updated
11 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Szasz-Janocha C, Vonderlin E, Lindenberg K. Treatment outcomes of a CBT-based group intervention for adolescents with Internet use disorders. J Behav Addict. 2020 Nov 16;9(4):978-989. doi: 10.1556/2006.2020.00089.

    PubMed 33216013

Questions about this trial

What is this clinical trial studying?

A study testing PROTECT+ in people with Mental Disorder, 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 1 inclusion and 1 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 11 Jul 2018. 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?

Changes in IUD symptom severity (self-report) (time frame: baseline, 1 month, 4-months, 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 NCT03582839, which also lists 1 linked publication.

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 11 Jul 2018.

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