FlexED: A Digital Gamified Early Intervention for Eating Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5
研究概览
简要总结
The purpose of this study is to test the feasibility of disseminating an intervention broadly. "FlexED" is a digital gamified intervention targeting eating disorder symptoms in young women and girls at risk by changing how they experience thoughts and feelings about their body. The digital intervention is based on Acceptance and Commitment Therapy (ACT).
Participants complete seven 20-minute sessions of the intervention using their smartphone over about 8 weeks. Participants also complete questionnaires bi-weekly as they go through the intervention. A final measurement is taken one month after the last digital intervention session. These surveys are all conducted online. Participants are in the study for up to 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female between the age of 18-25 years old.
排除标准
- •Non-English speaking
研究组 & 干预措施
FlexED
Seven 20-minute sessions of an online, multimedia application that teaches psychological flexibility with body-image related thoughts and feelings.
干预措施: FlexED (Behavioral)
结局指标
主要结局
Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5
时间窗: Baseline, Week 4, Week 8, Week 12
Self-report measure of body-image psychological flexibility. The measure consists of 5 items that ask about the degree to which thoughts and feelings about the body interfere with living. Higher scores indicate greater flexibility/adaptability.
Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10)
时间窗: Baseline, Week 4, Week 8, Week 12
A 10-item measure of psychological flexibility as a multidimensional construct with subscales of Openness, Awareness and Engagement. Higher scores indicate greater flexibility/adaptability.
Change in Weight Concern Scale Score
时间窗: Baseline, Week 8, Week 12
5-item measure of weight concerns (worry about weight, fear of weight gain, dieting history, importance of weight, fear of fatness). Elevated scores have been associated with the development of eating disorders.
Change from Baseline in the Eating Disorder Examination - Questionnaire Short Form (EDE-Q-SF)
时间窗: Baseline, Week 8, Week 12
Questionnaire format of the clinician-administered interview assessing eating disorder symptom severity, producing a Global score (main outcome) and 4 Subscale scores: Restraint, Eating Concerns, Weight Concerns, Shape Concerns. Higher scores indicate greater symptomatology.
Acceptability of the Intervention
时间窗: 8 weeks
Session completion rates
次要结局
未报告次要终点