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Efficacy of a guided internet-based intervention (iSOMA) for somatic symptoms and related distress in university students: study protocol of a randomised controlled trial
  1. Severin Hennemann1,
  2. Katja Böhme1,
  3. Harald Baumeister2,
  4. Eileen Bendig2,
  5. Maria Kleinstäuber3,
  6. David Daniel Ebert4,
  7. Michael Witthöft1
  1. 1 Department of Clinical Psychology, Psychotherapy and Experimental Psychopathology, Institute of Psychology, University of Mainz, Mainz, Germany
  2. 2 Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany
  3. 3 Department of Psychological Medicine, University of Auckland, Auckland, New Zealand
  4. 4 Department of Psychology, Clinical Psychology and Psychotherapy, Friedrich-Alexander University Erlangen Nuremberg, Erlangen, Germany
  1. Correspondence to Severin Hennemann; s.hennemann{at}uni-mainz.de

Abstract

Introduction Persistent 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 analysis This 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 dissemination Ethics approval has been granted. Results from this study will be published in peer-reviewed journals and presented at international conferences.

Trial registration number DRKS00014375; Pre-results.

  • medically unexplained symptoms
  • somatoform syndromes
  • internet intervention
  • university students
  • randomized controlled trial

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Footnotes

  • Patient consent for publication Not required.

  • Contributors All authors were involved in the concept and design of the study. SH wrote the draft of this manuscript, KB, MW, HB, EB, MK and DDE provided valuable revisions. All authors contributed to the further writing and approved the final version of the manuscript.

  • Funding The proposed trial received funding for the development of video content by the Johannes Gutenberg-University of Mainz. The associated studicare-project received funding from the German health insurance company BARMER.

  • Disclaimer The funding sources had no role in the design of this study and writing of this manuscript and will not have any role during its execution, analyses, interpretation of the data or decision to submit results.

  • Competing interests None declared.

  • Ethics approval This study protocol has been approved by the ethics committee of the Institute of Psychology of the University of Mainz (Ref. Nr. 2017-JGU-psychEK-012).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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