Efficacy of a guided internet-based intervention (iSOMA) for somatic symptoms and related distress in university students: study protocol of a randomised controlled trial

Abstract

IntroductionPersistent and distressing somatic symptoms are common in younger age cohorts such as university students. However, the majority does not receive adequate psychosocial care. Internet-based and mobile-based interventions may represent low threshold and effective extensions to reduce somatic and associated mental symptom severity. The planned study aims to investigate the feasibility and efficacy of an internet-based intervention in reducing somatic and psychological symptoms in an international population of university students with somatic symptom burden.Methods and analysisThis parallel two-armed randomised controlled trial evaluates an 8-week guided intervention, including web-based consecutive modules based on cognitive behavioural therapy (CBT) principles against a waitlist control group. Guidance will be provided by trained psychologists with weekly written supportive feedback. As part of the ‘Studicare’ project, the present study aims to recruit n=154 university students indicating somatic symptom burden at baseline in German-speaking universities. Self-report assessments will take place at baseline and after intervention completion (8, 16 weeks after randomisation). The primary outcome will be the severity of somatic symptoms and associated mental distress. Secondary outcomes include depression, (health) anxiety, disability, intervention satisfaction and adherence.Ethics and disseminationEthics approval has been granted. Results from this study will be published in peer-reviewed journals and presented at international conferences.Trial registration numberDRKS00014375; Pre-results.

Internet-based CBT for somatic symptom distress (iSOMA) in emerging adults: A randomized controlled trial.

“…All participants had unrestricted access to treatment-as-usual (TAU), which could have included, for example, psychological interventions, medication, or physical therapy (Henningsen et al, 2018). Detailed information on the study's procedures can be found in our study protocol (Hennemann et al, 2018). The study was preregistered at the German Clinical Trials Register (DRKS00014375, June 20, 2018) and was approved by the ethics committee of the Department of Psychology at the University of Mainz (Ref.…”

“…Analyses of primary and secondary outcomes were conducted with the intention-to-treat (ITT) sample, including all participants that were allocated to the trial arms, and gave informed consent for their data to be analyzed (see Figure 1). Other than described in the study protocol (Hennemann et al, 2018) we decided to conduct mixed-model analyses for repeated measures (MMRM) instead of ANCOVA, as MMRM allow to analyze all available data, including partial data at postassessment, without imputation and lead to unbiased estimates under the assumption of data missing at random (Bell & Rabe, 2020). Mixed models included group, time, and the Group × Time interaction as fixed factors, and a random intercept to model interindividual differences, based on diagonal covariance matrices and restricted maximum likelihood estimation (maximum of 100 iterations).…”

“…Participants who filled out the follow-up assessment were invited to take part in a voucher draw. Further putative moderating variables of the efficacy of iSOMA were collected at baseline (Hennemann et al, 2018), which will be analyzed and reported separately.…”

A therapist-guided internet-based cognitive behavioral therapy program for Hong Kong university students with psychological distress: A study protocol for a randomized controlled trial

“…As for university students, recent studies have developed some guided iCBT programs that address their mental health concerns, such as perfectionism ( Buhrman et al, 2020 ), anxiety and/or depression (e.g. Harrer et al, 2021 ; Raevuori et al, 2021 ;), procrastination ( Küchler et al, 2019 ), and somatic symptom distress ( Hennemann et al, 2018 ); and some unguided iCBT programs addressing psychological or physical problems ( Fabritiis et al, 2022 ), social anxiety and insomnia ( Attridge et al, 2020 ), and public speaking fear ( Tillfors et al, 2008 ). However, few iCBT programs specifically help university students cope with psychological distress.…”

Clinical and Cost-Effectiveness of PSYCHOnlineTHERAPY: Study Protocol of a Multicenter Blended Outpatient Psychotherapy Cluster Randomized Controlled Trial for Patients With Depressive and Anxiety Disorders

“…From a conceptual point of view, blended therapy approaches can be subdivided into (1) sequential and (2) integrated blended therapy concepts focusing on (a) maximizing the effectiveness of psychotherapy or (b) maximizing the efficiency of psychotherapy (19). Examples for sequential blended therapy concepts are IMIs provided prior to on-site psychotherapy, e.g., during waitingtime (25), or IMIs following on-site psychotherapy, e.g., as inpatient aftercare and relapse prevention (26)(27)(28).…”