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

Abstract

IntroductionExcessive 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 analysisThe 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 disseminationThe 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 numberDRKS00025994.

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“…The pilot phase sample comprised the first 20 participants included within the online short-term therapy. The online stepped care approach, provided via the smart@net app, contains a screening, and a subsequent assignment to a prevention or an intervention module [14]. To be eligible for participation in the in the SCAPIT study, prospective study participants were required to provide digital informed consent within the smart@net app, be aged between 16 and 67 years, and have a smartphone.…”

“…The intervention module included stepped interventions according to the severity of pathological internet use. Further information on the SCAPIT study procedure can be found in the study protocol [14].…”

“…Participants in the intervention condition were included in the pilot sample of online short-term therapy if one of the two conditions were fulfilled: (1) Lack of success in the previous intervention module 2 of the stepped care approach in terms of a CIUS score ≥ 21 and presence of 3 criteria for disorders due to predominantly online behavioral addictions sensu DSM-5 or one criterion sensu ICD-11, a clinically treatable symptomatology defined as5 criteria for disorders due to predominantly online behavioral addictions sensu DSM-5 or 3 criteria sensu ICD-11. (2) The presence of at least 6 criteria for disorders due to predominantly online behavioral addictions sensu DSM-5 also resulted in immediate enrollment in the pilot phase of online short-term therapy [14]. Inclusion in the pilot phase sample further required a public health insurance and the submission of the following signed documents: Treatment contract, therapy contract and treatment objective agreement, confidentiality statement.…”

“…The eCRF comprises the German versions of self-report measures. An overview of all survey measures and data collection points is presented in the study protocol [14]. The survey instruments included in the analysis are listed in table 1, comprising the following dimensions: Symptom severity of IUD and behavioral data of internet use, depression, anxiety and social phobia symptomatology, affectivity, self-efficacy expectancy, compulsivity, comorbid psychopathologies.…”

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“…Individuals may be 'stepped up' or 'stepped down' in the case of disorder enhancement or reduction. The stepped-care intervention has been implemented in many health domains, including depression and anxiety [34], Internet use disorders [36], and problematic substance use [37]. So far there is no established model of stepped care for AD.…”