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

NCT05621018 | Completed DMC

• 1 other identifier: Maze Out
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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)

Conditions

Eating Disorders

Keywords

serious games; coproduction; bulimia nervosa; anorexia nervosa; mHealth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• perceived help received from staff

  baseline and after 15 weeks

• feelings of ineffectiveness and self-image

  baseline and after 15 weeks

• interpersonal and intrapsychic interactions

  baseline, 8 weeks, 15 weeks

• family function

  baseline, 8 weeks, 15 weeks

• mental health literacy

  baseline, 15 weeks

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Control group

ACTIVE COMPARATOR

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

Device: Maze Out

Interventions

Maze Out DEVICE

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

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• No Danish speaker

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Maria Mercedes Guala

Odense C, 5000, Denmark

Location

Related Publications (2)

• Guala MM, Bikic A, Bul K, Clinton D, Mejdal A, Nielsen HN, Stoving RK, Nielsen AS. Maze-Out: A Serious Game to Enhance Treatment for Eating Disorders. A Randomized Controlled Trial. Int J Eat Disord. 2025 Aug;58(8):1558-1571. doi: 10.1002/eat.24458. Epub 2025 May 19.

  PMID: 40384493 DERIVED

• Guala MM, Bikic A, Bul K, Clinton D, Mejdal A, Nielsen HN, Stenager E, Sogaard Nielsen A. "Maze Out": a study protocol for a randomised controlled trial using a mix methods approach exploring the potential and examining the effectiveness of a serious game in the treatment of eating disorders. J Eat Disord. 2024 Mar 1;12(1):35. doi: 10.1186/s40337-024-00985-2.

  PMID: 38429839 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders; Bulimia Nervosa; Anorexia Nervosa

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 17, 2022
• Study Start: July 19, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 12, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

DK (1)