Effectiveness of a guided online mindfulness-focused intervention in a student population: Study protocol for a randomised control trial

Background Previous studies show that university students experience higher psychological stress than the general population, resulting in increased vulnerability for mental disorders for the student population. Online mindfulness interventions will be delivered to students as a potentially promisin...

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Main Authors: Harald Baumeister, Dana Schultchen, Ann-Marie Küchler, Christine Schillings, Felicitas Weineck, Alexander Karabatsiakis, David D. Ebert, Olga Pollatos
Format: Article
Language:English
Published: BMJ Publishing Group 2020-03-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/10/3/e032775.full
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author Harald Baumeister
Dana Schultchen
Ann-Marie Küchler
Christine Schillings
Felicitas Weineck
Alexander Karabatsiakis
David D. Ebert
Olga Pollatos
author_facet Harald Baumeister
Dana Schultchen
Ann-Marie Küchler
Christine Schillings
Felicitas Weineck
Alexander Karabatsiakis
David D. Ebert
Olga Pollatos
author_sort Harald Baumeister
collection DOAJ
description Background Previous studies show that university students experience higher psychological stress than the general population, resulting in increased vulnerability for mental disorders for the student population. Online mindfulness interventions will be delivered to students as a potentially promising and more flexible approach compared to face-to-face interventions with the aim of improving their mental health. This study purposes to investigate the effectiveness of a guided online mindfulness-focused intervention for university students by using both self-reported and psychobiological measures.Methods and analyses In this multicentre, two-armed randomised controlled trial with a parallel design, a guided version of the online mindfulness-focused intervention ‘StudiCare Mindfulness’ will be compared with a waitlist control group. In total, 120 participants will be recruited at different universities (of Applied Sciences) in (Neu-) Ulm. Data will be assessed prior to randomisation, after eight weeks (post-intervention) and six months after randomisation (follow-up). The primary outcome measure is mindfulness. The secondary outcome measures include depression, anxiety and stress levels, well-being, interoceptive sensibility, emotion regulation and alexithymia. Psychobiological parameters comprise interoceptive accuracy, hair cortisol and FKBP5 genotype. Sociodemographic variables, treatment expectations, side and adverse side effects, as well as intervention satisfaction and adherence will be assessed. All data analyses will be conducted according to the intention-to-treat principle.Ethics and dissemination All study procedures have been approved by the Ethics Committee of Ulm University (application No. 48/18). The findings will be disseminated widely through peer-reviewed publications and conference presentations.Trial registration number DRKS00014701.
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spelling doaj-art-57d7201111264e1fa1f9010382c01dee2025-08-20T02:37:29ZengBMJ Publishing GroupBMJ Open2044-60552020-03-0110310.1136/bmjopen-2019-032775Effectiveness of a guided online mindfulness-focused intervention in a student population: Study protocol for a randomised control trialHarald Baumeister0Dana Schultchen1Ann-Marie Küchler2Christine Schillings3Felicitas Weineck4Alexander Karabatsiakis5David D. Ebert6Olga Pollatos7Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, GermanyDepartment of Clinical & Health Psychology, Ulm University, Ulm, Baden-Württemberg, GermanyDepartment of Clinical Psychology & Psychotherapy, Ulm University, Ulm, Baden-Württemberg, GermanyDepartment of Clinical & Health Psychology, Ulm University, Ulm, Baden-Württemberg, GermanyDepartment of Clinical & Health Psychology, Ulm University, Ulm, Baden-Württemberg, GermanyClinical Psychology, University of Innsbruck, Innsbruck, Tyrol, AustriaDepartment of Clinical, Neuro- & Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, NetherlandsDepartment of Clinical & Health Psychology, Ulm University, Ulm, Baden-Württemberg, GermanyBackground Previous studies show that university students experience higher psychological stress than the general population, resulting in increased vulnerability for mental disorders for the student population. Online mindfulness interventions will be delivered to students as a potentially promising and more flexible approach compared to face-to-face interventions with the aim of improving their mental health. This study purposes to investigate the effectiveness of a guided online mindfulness-focused intervention for university students by using both self-reported and psychobiological measures.Methods and analyses In this multicentre, two-armed randomised controlled trial with a parallel design, a guided version of the online mindfulness-focused intervention ‘StudiCare Mindfulness’ will be compared with a waitlist control group. In total, 120 participants will be recruited at different universities (of Applied Sciences) in (Neu-) Ulm. Data will be assessed prior to randomisation, after eight weeks (post-intervention) and six months after randomisation (follow-up). The primary outcome measure is mindfulness. The secondary outcome measures include depression, anxiety and stress levels, well-being, interoceptive sensibility, emotion regulation and alexithymia. Psychobiological parameters comprise interoceptive accuracy, hair cortisol and FKBP5 genotype. Sociodemographic variables, treatment expectations, side and adverse side effects, as well as intervention satisfaction and adherence will be assessed. All data analyses will be conducted according to the intention-to-treat principle.Ethics and dissemination All study procedures have been approved by the Ethics Committee of Ulm University (application No. 48/18). The findings will be disseminated widely through peer-reviewed publications and conference presentations.Trial registration number DRKS00014701.https://bmjopen.bmj.com/content/10/3/e032775.full
spellingShingle Harald Baumeister
Dana Schultchen
Ann-Marie Küchler
Christine Schillings
Felicitas Weineck
Alexander Karabatsiakis
David D. Ebert
Olga Pollatos
Effectiveness of a guided online mindfulness-focused intervention in a student population: Study protocol for a randomised control trial
BMJ Open
title Effectiveness of a guided online mindfulness-focused intervention in a student population: Study protocol for a randomised control trial
title_full Effectiveness of a guided online mindfulness-focused intervention in a student population: Study protocol for a randomised control trial
title_fullStr Effectiveness of a guided online mindfulness-focused intervention in a student population: Study protocol for a randomised control trial
title_full_unstemmed Effectiveness of a guided online mindfulness-focused intervention in a student population: Study protocol for a randomised control trial
title_short Effectiveness of a guided online mindfulness-focused intervention in a student population: Study protocol for a randomised control trial
title_sort effectiveness of a guided online mindfulness focused intervention in a student population study protocol for a randomised control trial
url https://bmjopen.bmj.com/content/10/3/e032775.full
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