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Completed

NCT Number: NCT05621018

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

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Key information

Conditions

Eating Disorders Anorexia Nervosa Bulimia Nervosa Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maria Mercedes Guala

Odense C, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maze Out

Device

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

Primary outcomes

  1. Self-Efficacy

    Time frame: 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 outcomes

  1. perceived help received from staff

    Time frame: baseline and after 15 weeks

    measured by Brief INSPIRE: has one total score, ranging from 0 (low recovery support) to 100 (high recovery support).

  2. feelings of ineffectiveness and self-image

    Time frame: 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

  3. interpersonal and intrapsychic interactions

    Time frame: 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).

  4. family function

    Time frame: 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.

  5. mental health literacy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 17, 2022
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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