NCT03582839

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

July 11, 2018

Status Verified

June 1, 2018

Enrollment Period

2.7 years

First QC Date

June 4, 2018

Last Update Submit

June 27, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

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

  • 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.

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

  • 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.

    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

  • +3 more secondary outcomes

Study Arms (1)

PROTECT+

EXPERIMENTAL

The 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).

Behavioral: PROTECT+

Interventions

PROTECT+BEHAVIORAL

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).

PROTECT+

Eligibility Criteria

Age9 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents aged 9 to 19 years Self-selection

You may not qualify if:

  • Severe comorbid mental health disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Katajun Lindenberg, PhD

    Institut für Psychologie der Pädagogischen Hochschule Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jun.-Prof. Dr. K. Lindenberg

Study Record Dates

First Submitted

June 4, 2018

First Posted

July 11, 2018

Study Start

April 14, 2016

Primary Completion

December 23, 2018

Study Completion

April 1, 2019

Last Updated

July 11, 2018

Record last verified: 2018-06