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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | 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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| Control group | Active Comparator | Patients will be introduced to Maze Out. 15 weeks later they will follow the same procedure as intervention group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maze Out | Device | Play for 15 weeks, at list once a week the serious game: Maze Out |
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| Measure | Description | Time Frame |
|---|---|---|
| Self-Efficacy | 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. | at baseline, 8 weeks and 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| perceived help received from staff | measured by Brief INSPIRE: has one total score, ranging from 0 (low recovery support) to 100 (high recovery support). | baseline and after 15 weeks |
| feelings of ineffectiveness and self-image |
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Inclusion Criteria:
Exclusion Criteria:
• No Danish speaker
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Mercedes Guala | Odense C | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40384493 | Derived | 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. | |
| 38429839 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2024 | Mar 21, 2024 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D052018 | Bulimia Nervosa |
| D000856 | Anorexia Nervosa |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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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
| baseline and after 15 weeks |
| interpersonal and intrapsychic interactions | 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). | baseline, 8 weeks, 15 weeks |
| family function | measured by Family APGAR (Adaptability, Partnership, Growth, Affection, and Resolve) Scores range from 0 to 10 with higher scores indicating better functionality. | baseline, 8 weeks, 15 weeks |
| mental health literacy | 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 | baseline, 15 weeks |