"Maze Out": A Serious Game to Improve Self-efficacy and Mutual Understanding in Eating Disorders.

NCT ID: NCT05621018

Last Updated: 2024-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-19

Study Completion Date

2024-03-12

Brief Summary

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Eating Disorders (EDs) are mental disorders with long recovery time and high mortality. Despite the importance and extensive research in the field, an effective treatment for EDs has yet to be found.

In co-production with ED patients, clinicians, and technology experts a Serious Game called "Maze out" was developed and initially evaluated through a feasibility study. Maze out is an innovative first player tool focusing on improving self-efficacy, mutual understanding, and family functioning in adults with EDs.

The game has been evaluated through a usability study. Study findings demonstrate that patients found Maze out easy to use, meaningful and fun.

The usability study was thus a first step in developing and testing an evidence-based intervention to be implemented in the treatment repertoire of adolescents and adults with EDs.

The present study is a Randomized Controlled Trial, whereby the investigators will explore the effectiveness of Maze out as an additional treatment to Treatment as Usual (TAU)

Detailed Description

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Conditions

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Eating Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Patients will be introduced to Maze Out in an information meeting with the investigators and will afterwards receive a link with the game and a username. Each patient has to choose a code to start playing the game. The code will not be available for the investigators.

Group Type ACTIVE_COMPARATOR

Maze Out

Intervention Type DEVICE

Play for 15 weeks, at list once a week the serious game: Maze Out

Control group

Patients will be introduced to Maze Out. 15 weeks later they will follow the same procedure as intervention group.

Group Type ACTIVE_COMPARATOR

Maze Out

Intervention Type DEVICE

Play for 15 weeks, at list once a week the serious game: Maze Out

Interventions

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Maze Out

Play for 15 weeks, at list once a week the serious game: Maze Out

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All sexes aged 18+
* Diagnosis of anorexia nervosa, bulimia nervosa, other eating disorders and eating disorders unspecified (ICD-10 codes: F.50.0-F.50.9)
* Receiving treatment from one of psychiatry centers in the Mental Health Services of Region South Denmark, or in Endocrinology Services specialized in ED of Region South Denmark; or living in a mental health care institution in Region of Southern Denmark.

Exclusion Criteria

• No Danish speaker
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maria Mercedes Guala

Odense C, , Denmark

Site Status

Countries

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Denmark

References

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Guala MM, Bikic A, Bul K, Clinton D, Mejdal A, Nielsen HN, Stoving RK, Nielsen AS. Maze-Out: A Serious Game to Enhance Treatment for Eating Disorders. A Randomized Controlled Trial. Int J Eat Disord. 2025 Aug;58(8):1558-1571. doi: 10.1002/eat.24458. Epub 2025 May 19.

Reference Type DERIVED
PMID: 40384493 (View on PubMed)

Guala MM, Bikic A, Bul K, Clinton D, Mejdal A, Nielsen HN, Stenager E, Sogaard Nielsen A. "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. J Eat Disord. 2024 Mar 1;12(1):35. doi: 10.1186/s40337-024-00985-2.

Reference Type DERIVED
PMID: 38429839 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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Maze Out

Identifier Type: -

Identifier Source: org_study_id

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