Eating DisordersNCT05621018
"Maze Out": A Serious Game to Improve Self-efficacy and Mutual Understanding in Eating Disorders.
A study testing Maze Out in people with Eating Disorders, run by University of Southern Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Maze Out
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Jul 2022to 12 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No Danish speaker
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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
- Being tested
- Maze Out
- Keywords
- serious games, coproduction, bulimia nervosa, anorexia nervosa, mHealth
- Medical subject headings
- Feeding and Eating Disorders, Bulimia Nervosa, Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maze OutDevice
Play for 15 weeks, at list once a week the serious game: Maze Out
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Maze Out |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline, 8 weeks and 15 weeks
Secondary outcomes (5)
perceived help received from staff
measured by Brief INSPIRE: has one total score, ranging from 0 (low recovery support) to 100 (high recovery support).
Measured: baseline and after 15 weeks
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
Measured: baseline and after 15 weeks
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).
Measured: baseline, 8 weeks, 15 weeks
family function
measured by Family APGAR (Adaptability, Partnership, Growth, Affection, and Resolve) Scores range from 0 to 10 with higher scores indicating better functionality.
Measured: baseline, 8 weeks, 15 weeks
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
Measured: baseline, 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start19 Jul 2022
- Primary completion1 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621018
- Sponsor's protocol ID
- Maze Out
- Status last verified
- Mar 2024
- First submitted
- 2 Nov 2022
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40384493Guala 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.
PubMed 38429839
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05621018
- Acronym / sponsor ID
- Maze Out
- Conditions
- Eating Disorders
- Keywords
- serious games, coproduction, bulimia nervosa, anorexia nervosa, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Device: Maze OutPatients 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 | Active comparator | Device: Maze OutPatients will be introduced to Maze Out. 15 weeks later they will follow the same procedure as intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- No Danish speaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maze OutPlay for 15 weeks, at list once a week the serious game: Maze Out | Device | Control group, Intervention group |
Primary outcome
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.
5 secondary outcomes
perceived help received from staff
Time frame: baseline and after 15 weeks
feelings of ineffectiveness and self-image
Time frame: baseline and after 15 weeks
interpersonal and intrapsychic interactions
Time frame: baseline, 8 weeks, 15 weeks
family function
Time frame: baseline, 8 weeks, 15 weeks
mental health literacy
Time frame: baseline, 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Derived from this study: PubMed 40384493Guala 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.
- Derived from this study: PubMed 38429839Guala 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maze Out in people with Eating Disorders, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Efficacy (time frame: at baseline, 8 weeks and 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05621018, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.