StudiCare mindfulness—study protocol of a randomized controlled trial evaluating an internet- and mobile-based intervention for college students with no and “on demand” guidance

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Abstract

Background

College is an exciting but also challenging time with an increased risk for mental health issues. Only a minority of the college students concerned get professional help, a problem that might be improvable by internet- and mobile-based interventions (IMIs). However, adherence of IMIs is a concern. While guidance might be a solution, it is resource-intensive, derailing potential implementation on population level. The first aim of this trial is to evaluate the efficacy of the IMI StudiCare Mindfulness (StudiCare-M) for college students with “on demand” and no guidance. The second aim is to examine potential moderators and mediators, contributing to the questions of “how” and “for whom” such interventions work.

Methods

In this three-armed randomized controlled trial, both an unguided and “guidance on demand” (GoD) condition of StudiCare-M are compared to a waitlist control group. StudiCare-M is based on principles of acceptance and commitment therapy and stress management and consists of 7 modules plus two booster sessions. Participants in the GoD condition may ask their e-coach for support whenever needed. A total of 387 college students with moderate to low mindfulness are recruited at 15+ cooperating universities in Germany, Austria, and Switzerland via circular emails. Assessments take place before as well as 1, 2, and 6 months after randomization. The primary outcome is mindfulness. Secondary outcomes include stress, depression, anxiety, interoception, presenteeism, wellbeing, intervention satisfaction, adherence, and potential side effects. Among examined moderators and mediators are sociodemographic variables, pre-treatment symptomatology, treatment expectancy, self-efficacy, cognitive fusion, emotion regulation, and alexithymia. All data will be analyzed according to intention-to-treat (ITT) principles.

Discussion

Providing effective interventions to help college students become more resilient can make a valuable contribution to the health and functionality of future society. If effective under the condition of minimal or no guidance, StudiCare-M offers a low-threshold potentially resource-efficient possibility to enhance college student mental health on a population level. Moderation- and mediation analyses will deliver further insights for optimization of target groups and intervention content.

Trial registration

WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register DRKS00014774. Registered on 18 May 2018.

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Most cited references 95

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Author and article information

Contributors

Ann-Marie Küchler:

ORCID: http://orcid.org/0000-0003-3305-4892

ann-marie.kuechler@uni-ulm.de

Dana Schultchen: dana.schultchen@uni-ulm.de

Olga Pollatos: olga.pollatos@uni-ulm.de

Morten Moshagen: morten.moshagen@uni-ulm.de

David D. Ebert: d.d.ebert@vu.nl

Harald Baumeister: harald.baumeister@uni-ulm.de

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 26 November 2020

Publication date PMC-release: 26 November 2020

Publication date Collection: 2020

Volume: 21

Electronic Location Identifier: 975

Affiliations

[1 ]GRID grid.6582.9, ISNI 0000 0004 1936 9748, Department of Clinical Psychology and Psychotherapy, , Institute for Psychology and Education, Ulm University, ; Albert-Einstein-Allee 47, 89081 Ulm, Germany

[2 ]GRID grid.6582.9, ISNI 0000 0004 1936 9748, Department of Clinical and Health Psychology, , Ulm University, ; Ulm, Germany

[3 ]GRID grid.6582.9, ISNI 0000 0004 1936 9748, Department of Quantitative Methods in Psychology, , Ulm University, ; Ulm, Germany

[4 ]GRID grid.12380.38, ISNI 0000 0004 1754 9227, Department of Clinical, Neuro- & Developmental Psychology, , Vrije Universiteit Amsterdam, ; Amsterdam, Netherlands

Author information

Ann-Marie Küchler http://orcid.org/0000-0003-3305-4892

Article

Publisher ID: 4868

DOI: 10.1186/s13063-020-04868-0

PMC ID: 7691111

PubMed ID: 33243300

SO-VID: 73a90314-a223-491b-a3f9-d01766f01457

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 26 July 2019

Date accepted : 4 November 2020

Funding

Funded by: Barmer

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: college students,university students,mindfulness,depression,anxiety,internet- and mobile-based interventions,e-health,efficacy,moderators and mediators,guidance on demand

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ScienceOpen disciplines: Medicine

Keywords: college students, university students, mindfulness, depression, anxiety, internet- and mobile-based interventions, e-health, efficacy, moderators and mediators, guidance on demand

StudiCare mindfulness—study protocol of a randomized controlled trial evaluating an internet- and mobile-based intervention for college students with no and “on demand” guidance

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Abstract

Background

Methods

Discussion

Trial registration

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25th European Students' Conference

Most cited references 95

G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences

A brief measure for assessing generalized anxiety disorder: the GAD-7.

The PHQ-9: validity of a brief depression severity measure.

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