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

Study Overview
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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)

Official Title
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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.

Conditions
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Eating Disorders

Intervention / Treatment
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* Device: Maze Out


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>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. | Device: Maze Out<br>* Play for 15 weeks, at list once a week the serious game: Maze Out<br>|
| Active Comparator: Control group<br>Patients will be introduced to Maze Out. 15 weeks later they will follow the same procedure as intervention group. | Device: Maze Out<br>* Play for 15 weeks, at list once a week the serious game: Maze Out<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Efficacy | measured by The General Self-Efficacy questionnaire, 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 | at the baseline | 
| Self-Efficacy | measured by The General Self-Efficacy questionnaire | after 8 weeks | 
| Self-Efficacy | measured by The General Self-Efficacy questionnaire | after 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| perceived help received from staff | measured by Brief INSPIRE. | after 8 weeks | 
| perceived help received from staff | measured by Brief INSPIRE | after 15 weeks | 
| eating disorders symptoms | 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. | baseline | 
| eating disorders symptoms | measured by EDI 3 (Eating Disorders Inventory) | after 8 weeks | 
| eating disorders symptoms | measured by EDI 3 (Eating Disorders Inventory) | 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 | 
| interpersonal and intrapsychic interactions | measured by SAS-B (Structural Analysis of Social Behavior Questionnaire) | baseline | 
| interpersonal and intrapsychic interactions | measured by SAS-B (Structural Analysis of Social Behavior Questionnaire) | 8 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 | 
| family function | measured by Family APGAR | 8 weeks | 
| family function | measured by Family APGAR | 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 | 
| mental health literacy | measured by MHLS (The Mental Health Literacy Scale), | 8 weeks | 
| mental health literacy | measured by MHLS (The Mental Health Literacy Scale), | 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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serious games, coproduction, bulimia nervosa, anorexia nervosa, mHealth