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

Eating Disorders Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05621018
• Other study ID #: Maze Out
• Status: Completed
• Phase: N/A
• Start date: July 19, 2022
• Est. completion date: March 12, 2024

Study information

• Verified date: March 2024
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: March 12, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eating Disorders
• Feeding and Eating Disorders

Intervention

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

Locations

Country	Name	City	State
Denmark	Maria Mercedes Guala	Odense C

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	feelings of ineffectiveness and self-image	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
Secondary	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
Secondary	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
Secondary	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