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

Primary Purpose

Eating Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Maze Out
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring serious games, coproduction, bulimia nervosa, anorexia nervosa, mHealth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maria Mercedes GualaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Self-Efficacy
measured by The General Self-Efficacy questionnaire, 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
Self-Efficacy
measured by The General Self-Efficacy questionnaire
Self-Efficacy
measured by The General Self-Efficacy questionnaire

Secondary Outcome Measures

perceived help received from staff
measured by Brief INSPIRE: has one total score, ranging from 0 (low recovery support) to 100 (high recovery support).
perceived help received from staff
measured by Brief INSPIRE.
perceived help received from staff
measured by Brief INSPIRE
eating disorders symptoms
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.
eating disorders symptoms
measured by EDI 3 (Eating Disorders Inventory)
eating disorders symptoms
measured by EDI 3 (Eating Disorders Inventory)
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).
interpersonal and intrapsychic interactions
measured by SAS-B (Structural Analysis of Social Behavior Questionnaire)
interpersonal and intrapsychic interactions
measured by SAS-B (Structural Analysis of Social Behavior Questionnaire)
family function
measured by Family APGAR (Adaptability, Partnership, Growth, Affection, and Resolve) Scores range from 0 to 10 with higher scores indicating better functionality.
family function
measured by Family APGAR
family function
measured by Family APGAR
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
mental health literacy
measured by MHLS (The Mental Health Literacy Scale),
mental health literacy
measured by MHLS (The Mental Health Literacy Scale),

Full Information

First Posted
November 2, 2022
Last Updated
October 3, 2023
Sponsor
University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05621018
Brief Title
"Maze Out": A Serious Game to Improve Self-efficacy and Mutual Understanding in Eating Disorders.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
serious games, coproduction, bulimia nervosa, anorexia nervosa, mHealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients will be introduced to Maze Out. 15 weeks later they will follow the same procedure as intervention group.
Intervention Type
Device
Intervention Name(s)
Maze Out
Intervention Description
Play for 15 weeks, at list once a week the serious game: Maze Out
Primary Outcome Measure Information:
Title
Self-Efficacy
Description
measured by The General Self-Efficacy questionnaire, 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
Time Frame
at the baseline
Title
Self-Efficacy
Description
measured by The General Self-Efficacy questionnaire
Time Frame
after 8 weeks
Title
Self-Efficacy
Description
measured by The General Self-Efficacy questionnaire
Time Frame
after 15 weeks
Secondary Outcome Measure Information:
Title
perceived help received from staff
Description
measured by Brief INSPIRE: has one total score, ranging from 0 (low recovery support) to 100 (high recovery support).
Time Frame
baseline
Title
perceived help received from staff
Description
measured by Brief INSPIRE.
Time Frame
after 8 weeks
Title
perceived help received from staff
Description
measured by Brief INSPIRE
Time Frame
after 15 weeks
Title
eating disorders symptoms
Description
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.
Time Frame
baseline
Title
eating disorders symptoms
Description
measured by EDI 3 (Eating Disorders Inventory)
Time Frame
after 8 weeks
Title
eating disorders symptoms
Description
measured by EDI 3 (Eating Disorders Inventory)
Time Frame
after 15 weeks
Title
interpersonal and intrapsychic interactions
Description
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).
Time Frame
baseline
Title
interpersonal and intrapsychic interactions
Description
measured by SAS-B (Structural Analysis of Social Behavior Questionnaire)
Time Frame
baseline
Title
interpersonal and intrapsychic interactions
Description
measured by SAS-B (Structural Analysis of Social Behavior Questionnaire)
Time Frame
8 weeks
Title
family function
Description
measured by Family APGAR (Adaptability, Partnership, Growth, Affection, and Resolve) Scores range from 0 to 10 with higher scores indicating better functionality.
Time Frame
baseline
Title
family function
Description
measured by Family APGAR
Time Frame
8 weeks
Title
family function
Description
measured by Family APGAR
Time Frame
15 weeks
Title
mental health literacy
Description
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
Time Frame
baseline
Title
mental health literacy
Description
measured by MHLS (The Mental Health Literacy Scale),
Time Frame
8 weeks
Title
mental health literacy
Description
measured by MHLS (The Mental Health Literacy Scale),
Time Frame
15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria M Guala, ph D student
Phone
+4560635345
Email
mguala@health.sdu.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Anette A Søgaard Nielsen, professor
Phone
+4529135825
Email
ansnielsen@health.sdu.dk
Facility Information:
Facility Name
Maria Mercedes Guala
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria M Guala
Phone
+4560635345
Email
mguala@health.sdu.dk

12. IPD Sharing Statement

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

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