Study protocol for a randomised controlled trial of an e-health stepped care approach for the treatment of internet use disorders versus a placebo condition: the SCAPIT study
Maren Vens,
Inke König,
Hans-Jürgen Rumpf,
Klaus Wölfling,
Stefan Borgwardt,
Anja Bischof,
Dominique Brandt,
Samantha Schlossarek,
Dmitri Rozgonjuk,
Jennifer Wernicke,
Christopher Kannen,
Michael Dreier,
Harriet Salbach,
Lara Basenach,
Thomas Mößle,
Denise Olbrich,
Christian Montag
Affiliations
Maren Vens
Institute of Medical Biometry and Statistics, University of Lübeck, Lübeck, Germany
Inke König
Institute of Medical Biometry and Statistics, University of Lübeck, Lübeck, Germany
Hans-Jürgen Rumpf
University of Lübeck Institute of the History of Medicine and Science Research, Lubeck, Schleswig-Holstein, Germany
Klaus Wölfling
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Mainz, Johannes Gutenberg University Mainz, Mainz, Germany
Stefan Borgwardt
Department of Psychiatry, Psychosomatics and Psychotherapy, University of Lübeck, Lubeck, Germany
Anja Bischof
Department of Psychiatry and Psychotherapy, University of Lübeck, Lubeck, Germany
Dominique Brandt
Department of Psychiatry and Psychotherapy, University of Lübeck, Lubeck, Germany
Samantha Schlossarek
Department of Psychiatry and Psychotherapy, University of Lübeck, Lubeck, Germany
Dmitri Rozgonjuk
Department of Molecular Psychology, University of Ulm, Ulm, Germany
Jennifer Wernicke
Department of Molecular Psychology, University of Ulm, Ulm, Germany
Christopher Kannen
Department of Molecular Psychology, University of Ulm, Ulm, Germany
Michael Dreier
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Mainz, Johannes Gutenberg-University Mainz, Mainz, Germany
Harriet Salbach
Department of Education and Psychology, Free University of Berlin, Berlin, Germany
Lara Basenach
Department of Education and Psychology, Free University of Berlin, Berlin, Germany
Thomas Mößle
Media Protect e.V, Emmendingen, Germany
Denise Olbrich
Center for Clinical Studies, University of Lübeck, Lubeck, Germany
Christian Montag
Department of Molecular Psychology, University of Ulm, Ulm, Germany
Introduction Excessive internet use can lead to problems for some individuals. The WHO has introduced Gaming Disorder in the International Classification of Diseases-11 (ICD-11). Previous research has shown that other internet applications can cause serious mental health problems as well. It is important to provide measures of prevention, early intervention and therapy for internet use disorders (IUDs).Methods and analysis The study ‘Stepped Care Approach for Problematic Internet use Treatment’ is a randomised, two-arm, parallel-group, observer-blind trial. The aim of the study is to investigate if a stepped care approach is effective to reduce symptom severity for IUD. The sample is primarily recruited online with a focus on employees in companies with support of health insurances. After screening, the stepped care approach depends on the success of the previous step—that is, the successful reduction of criteria—and comprise: (1) app-intervention with questionnaires and feedback, (2) two telephone counsellings (duration: 50 min) based on motivational interviewing, (3) online therapy over 17 weeks (15 weekly group sessions, eight individual sessions) based on cognitive–behavioural therapy. A follow-up is conducted after 6 months. A total of 860 participants will be randomised. Hierarchical testing procedure is used to test the coprimary endpoints number of Diagnostic and Statistical Manual of Mental Disorders, fifth edition and ICD-11 criteria. Primary analysis will be performed with a sequential logit model.Ethics and dissemination The study has been approved by the Ethics Committees of the Universities of Lübeck (file number: 21-068), Mainz (file number: 2021-15907) and Berlin (file number: 015.2021). Results will be reported in accordance to the CONSORT statement. If the approach is superior to the control condition, it may serve as part of treatment for IUD.Trial registration number DRKS00025994.
