"Maze Out": A Serious Game to Improve Self-efficacy and Mutual Understanding in Eating Disorders.
March 21, 2024 updated by: University of Southern Denmark
A Randomized Controlled Trial of "Maze Out": A Serious Game to Improve Self-efficacy, Mutual Understanding and Improved Family Functioning in People With Eating Disorders.
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)
Study Overview
Study Type
Interventional
Enrollment (Actual)
143
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Odense C, Denmark, 5000
- Maria Mercedes Guala
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: 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.
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Play for 15 weeks, at list once a week the serious game: Maze Out
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Active Comparator: Control group
Patients will be introduced to Maze Out. 15 weeks later they will follow the same procedure as intervention group.
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Play for 15 weeks, at list once a week the serious game: Maze Out
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Efficacy
Time Frame: at baseline, 8 weeks and 15 weeks
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measured by a 5-item self-efficacy questionnaire (5-item SE_ED), is a 5-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life when having an Eating Disorder.Min.score:
0, max.score:40; higher score shows better outcome.
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at baseline, 8 weeks and 15 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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perceived help received from staff
Time Frame: baseline and after 15 weeks
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measured by Brief INSPIRE: has one total score, ranging from 0 (low recovery support) to 100 (high recovery support).
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baseline and after 15 weeks
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feelings of ineffectiveness and self-image
Time Frame: baseline and after 15 weeks
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measured by Eating Disorders Inventory (EDI-3): consists of 91 items organized onto 12 primary scales, consisting of 3 eating-disorder-specific scales and 9 general psychological scales that are highly relevant to, but not specific to, eating disorders.This secondary outcome will focus in two domains: Inefectiveness and Interpersonal problems
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baseline and after 15 weeks
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interpersonal and intrapsychic interactions
Time Frame: baseline, 8 weeks, 15 weeks
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measured by Structural Analysis of Social Behavior Questionnaire (SAS-B) Designed to measure the patient's perceptions of self and others, based on trait x state x situational philosophy and Structural Analysis of Social Behavior.can
be used to assess interpersonal and intrapsychic interactions in terms of three underlying dimensions: (a) focus (other, self, introject), (b) affiliation-hostility (love-hate), and (c) interdependence-independence (enmeshment-differentiation).
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baseline, 8 weeks, 15 weeks
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family function
Time Frame: baseline, 8 weeks, 15 weeks
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measured by Family APGAR (Adaptability, Partnership, Growth, Affection, and Resolve) Scores range from 0 to 10 with higher scores indicating better functionality.
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baseline, 8 weeks, 15 weeks
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mental health literacy
Time Frame: baseline, 15 weeks
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measured by MHLS (The Mental Health Literacy Scale), The Mental Health Literacy Scale (MHLS) is a 35 item questionnaire looking at the respondents understanding of mental health.Max score=160; Min score=35
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baseline, 15 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 19, 2022
Primary Completion (Actual)
March 1, 2024
Study Completion (Actual)
March 12, 2024
Study Registration Dates
First Submitted
November 2, 2022
First Submitted That Met QC Criteria
November 11, 2022
First Posted (Actual)
November 17, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Maze Out
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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