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

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 soma...

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Main Authors: Harald Baumeister, Michael Witthöft, Eileen Bendig, Severin Hennemann, Katja Böhme, Maria Kleinstäuber, David Daniel Ebert
Format: Article
Language:English
Published: BMJ Publishing Group 2018-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/8/12/e024929.full
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author Harald Baumeister
Michael Witthöft
Eileen Bendig
Severin Hennemann
Katja Böhme
Maria Kleinstäuber
David Daniel Ebert
author_facet Harald Baumeister
Michael Witthöft
Eileen Bendig
Severin Hennemann
Katja Böhme
Maria Kleinstäuber
David Daniel Ebert
author_sort Harald Baumeister
collection DOAJ
description 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.
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spelling doaj-art-3584d0f5898e48d498dcb39608b3b07f2025-02-09T18:30:11ZengBMJ Publishing GroupBMJ Open2044-60552018-12-0181210.1136/bmjopen-2018-024929Efficacy of a guided internet-based intervention (iSOMA) for somatic symptoms and related distress in university students: study protocol of a randomised controlled trialHarald Baumeister0Michael Witthöft1Eileen Bendig2Severin Hennemann3Katja Böhme4Maria Kleinstäuber5David Daniel Ebert6Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, GermanyDepartment of Clinical Psychology, Psychotherapy and Experimental Psychopathology, Johannes Gutenberg University Mainz, Mainz, GermanyDepartment of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany1 Department of Clinical Psychology, Psychotherapy and Experimental Psychopathology, Institute of Psychology, University of Mainz, Mainz, Germany1 Department of Clinical Psychology, Psychotherapy and Experimental Psychopathology, Institute of Psychology, University of Mainz, Mainz, Germany3 Department of Psychological Medicine, University of Auckland, Auckland, New Zealand4 Institute for Psychology & Digital Mental Health Care, Department of Sports and Health Sciences, Technical University, Munich, GermanyIntroduction 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.https://bmjopen.bmj.com/content/8/12/e024929.full
spellingShingle Harald Baumeister
Michael Witthöft
Eileen Bendig
Severin Hennemann
Katja Böhme
Maria Kleinstäuber
David Daniel Ebert
Efficacy of a guided internet-based intervention (iSOMA) for somatic symptoms and related distress in university students: study protocol of a randomised controlled trial
BMJ Open
title Efficacy of a guided internet-based intervention (iSOMA) for somatic symptoms and related distress in university students: study protocol of a randomised controlled trial
title_full Efficacy of a guided internet-based intervention (iSOMA) for somatic symptoms and related distress in university students: study protocol of a randomised controlled trial
title_fullStr Efficacy of a guided internet-based intervention (iSOMA) for somatic symptoms and related distress in university students: study protocol of a randomised controlled trial
title_full_unstemmed Efficacy of a guided internet-based intervention (iSOMA) for somatic symptoms and related distress in university students: study protocol of a randomised controlled trial
title_short Efficacy of a guided internet-based intervention (iSOMA) for somatic symptoms and related distress in university students: study protocol of a randomised controlled trial
title_sort efficacy of a guided internet based intervention isoma for somatic symptoms and related distress in university students study protocol of a randomised controlled trial
url https://bmjopen.bmj.com/content/8/12/e024929.full
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