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

Not Applicable

Completed

• Conditions: Eating Disorders
• Interventions: Device: Maze Out

• Registration Number: NCT05621018
• Lead Sponsor: University of Southern Denmark

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-19
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-11
• Study First Posted: 2022-11-17
• Status Verified: 2024-03
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-12
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Self-Efficacy	at baseline, 8 weeks and 15 weeks	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.

Secondary Outcome Measures

Name	Time	Method
perceived help received from staff	baseline and after 15 weeks	measured by Brief INSPIRE: has one total score, ranging from 0 (low recovery support) to 100 (high recovery support).
mental health literacy	baseline, 15 weeks	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
interpersonal and intrapsychic interactions	baseline, 8 weeks, 15 weeks	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).
family function	baseline, 8 weeks, 15 weeks	measured by Family APGAR (Adaptability, Partnership, Growth, Affection, and Resolve) Scores range from 0 to 10 with higher scores indicating better functionality.
feelings of ineffectiveness and self-image	baseline and after 15 weeks	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

Trial Locations

Locations (1)

Maria Mercedes Guala; 🇩🇰 Odense C, Denmark