“Maze Out”: A study protocol for a randomised controlled trial using a mix methods approach exploring the potential and examining the effectiveness of a serious game in the treatment of eating disorders

Maria Guala, Aida Bikic, Kim Bul, David Clinton, Anna Mejdal, Angelina Isabella Mellentin, Helene Nygaard Nielsen, Elsebeth Stenager, Anette Søgaard Nielsen

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Abstract

Background: Eating Disorders (ED) are severe and costly mental health disorders. The effects of existing treatment approaches are limited and there is a need to develop novel interventions, including digital strategies that can increase engagement and effectiveness. Maze Out is a new serious game coproduced by patients and ED therapists, which allows patients to “play” with the reality of an ED and reflect on associated challenges.

Objectives: The present study has two main objectives: 1) to evaluate the effectiveness of adding Maze Out to treatment as usual (TAU) in a randomised controlled trial (RCT); and 2) to examine in depth the potential of Maze Out by examining how it is perceived and used in the context of an RCT.

Methods: Participants will be recruited from mental health care services, endocrinology departments or Community Centres offering treatment for ED. Patients suffering from ED (N=94) will be randomised to either TAU or TAU plus Maze Out. Primary outcome will be measured in terms of changes in self-efficacy, measured by a 5-item self-efficacy questionnaire (5-item SE_ED). Secondary outcome measures will include feelings of ineffectiveness and self-image, as measured by Brief INSPIRE-O and Structural Analysis of Social Behaviour Intrex Questionnaire (SASB). Data will be collected at baseline (enrolment in the study), and subsequently 8 and 15 weeks after inclusion. Experiences of playing Maze Out will be examined in a sub-sample (n=30) of participants, utilising both quantitative user analytics and qualitative interview data of patients, interview data of significant others, and healthcare professionals to explore the possible impact of Maze Out on disorder insight, communication patterns between patients and therapists and understanding of their disorder.

Discussion: To our knowledge Maze Out is the first serious game coproduced by patients and therapists. It is a novel and theoretically grounded intervention that may significantly contribute to the healing process of ED. If found effective, the potential for wide-spread impact and scalability is considerable.

Trial registration: ClinicalTrials.gov NCT05621018
Original languageEnglish
Article number35
Number of pages10
JournalJournal of Eating Disorders
Volume12
DOIs
Publication statusPublished - 1 Mar 2024

Bibliographical note

This 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.

Funder

Open access funding provided by University of Southern Denmark The study is funded by TrygFonden, the Psychiatric Research Foundation, Region of Southern Denmark and, Helsefonden. The funding organizations are independent and have no involvement in the design, data collection or analysis of the current trial.

Keywords

  • eating disorders
  • serious games
  • self-efficacy
  • co-production
  • randomised controlled trial

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