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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- Self-Efficacy
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •No Danish speaker
结局指标
主要结局
Self-Efficacy
时间窗: 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.
次要结局
- 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)