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Clinical Trials/NCT05621018
NCT05621018
Completed
Not Applicable

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.

University of Southern Denmark1 site in 1 country143 target enrollmentJuly 19, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Eating Disorders
Sponsor
University of Southern Denmark
Enrollment
143
Locations
1
Primary Endpoint
Self-Efficacy
Status
Completed
Last Updated
2 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
July 19, 2022
End Date
March 12, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • perceived help received from staff(baseline and after 15 weeks)
  • mental health literacy(baseline, 15 weeks)
  • interpersonal and intrapsychic interactions(baseline, 8 weeks, 15 weeks)
  • family function(baseline, 8 weeks, 15 weeks)
  • feelings of ineffectiveness and self-image(baseline and after 15 weeks)

Study Sites (1)

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