A Randomized Controlled Trial Testing a Digital, Gamified Early Intervention for Eating Disorders ("FlexED")
2026年8月26日 更新者：Duke University
A Randomized Controlled Trial Testing Mechanism Engagement and Clinical Impact of FlexED: A Digital, Gamified Early Intervention for Eating Disorders
The goal of this clinical trial is to test whether a new digital intervention decreases 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 will be randomly assigned (like a coin toss) to either the new digital intervention or education modules completed online.
The main questions are:
Does the digital intervention change how participants experience thoughts and feelings about their body or how they react to eating disorder triggers (e.g., images of idealized bodies)? Do these changes lead to decreases in eating disorder symptoms? Is the intervention acceptable and at the right dose?
Participants will:
Complete seven brief digital sessions over about 8 weeks. Complete interviews, surveys and lab assessments of reaction to body-related words and images.
Participants are followed for about 1 year.
研究概览
研究类型
介入性
注册 (估计的)
128
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Rhonda M Merwin, Ph.D.
- 电话号码：919-681-7231
- 邮箱：rhonda.merwin@duke.edu
研究联系人备份
- 姓名：Dottie R Mayo
- 电话号码：919-668-1935
- 邮箱：drm72@duke.edu
学习地点
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North Carolina
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Durham、North Carolina、美国、27705
- 招聘中
- Duke University
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首席研究员：
- Rhonda M Merwin, Ph.D.
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接触：
- Dottie R Mayo
- 电话号码：919-668-1935
- 邮箱：drm72@duke.edu
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- Female between the age of 15-25 years old.
- Weight Concerns Scale score of >=47.
- Endorses one or more eating disorder behaviors (e.g., extreme dieting or exercise, subjective or objective binge eating, purging behaviors).
Exclusion Criteria:
- Currently meets the DSM-5 diagnostic criteria for full threshold anorexia nervosa, bulimia nervosa or binge eating disorder, or for an eating or feeding disorder that does not include body-image or weight related distress and is not the focus of study (e.g., ARFID, PICA) or a past diagnosis of one of these disorders.
- Change in psychotropic medications in the past month.
- Active suicidal ideation, current substance use disorder or diagnosed psychotic disorder.
- Bipolar disorder not being treated with medication.
- Currently in treatment for an eating disorder.
- Non-English speaking.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的："FlexED"
Seven 20-minute sessions of an online, multimedia application that teaches psychological flexibility with body-image related thoughts and feelings.
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Intervention consists of seven 20-minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT).
Participants learn psychological flexibility skills for body-image distress by completing interactive exercises and games with a relatable character and story line and receive rewards that reinforce learning.
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有源比较器：Educational Control
Seven 20-minute online education sessions about eating disorders.
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Intervention consists of seven digital online sessions of education about eating disorders and body image.
Participants read information about how eating disorders develop and their impact on health and well-being and body image, watch videos and complete quizzes to check knowledge.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)
大体时间：Baseline, 4, 8, 12, 24, 36, 48 weeks
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Self-report measure of body-image psychological flexibility.
The measure consists of 13 (full measure) or 5 (short measure) items that ask about the degree to which thoughts and feelings about the body interfere with living.
Higher scores indicate greater flexibility/adaptability.
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Baseline, 4, 8, 12, 24, 36, 48 weeks
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Change from Baseline in the Body-Image Stroop Bias Score
大体时间：Baseline, 8 weeks, 24 weeks
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Change in reaction time to body-related versus neutral words in an emotional stroop paradigm.
In this paradigm, participants identify the color of the written word as quickly as possible.
Differences in reaction time between emotionally relevant words and neutral words is calculated as a bias score.
Lower bias scores indicate improvement.
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Baseline, 8 weeks, 24 weeks
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Change from Baseline in Eye Gaze Fixations - Body-Image Related Images
大体时间：Baseline, 8 weeks, 24 weeks
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Change in the number of fixations on body-image related images, including idealized bodies, overweight bodies, body-weight measurement, and images of binge eating and body-related distress.
Fewer fixations indicate improvement.
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Baseline, 8 weeks, 24 weeks
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Acceptability of the intervention
大体时间：8 weeks
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Enrollment targets met, >70% of participants that start the intervention will complete >80%, >70% of participants and sessions will have user inputs indicating engagement.
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8 weeks
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Change from Baseline in Eating Disorder Examination (EDE)
大体时间：Baseline, 12 weeks, 24 weeks
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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.
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Baseline, 12 weeks, 24 weeks
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Change from Baseline in the Eating Disorder Examination - Questionnaire (EDE-Q)
大体时间：Baseline, 12, 24, 36, 48 weeks
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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.
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Baseline, 12, 24, 36, 48 weeks
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Change from Baseline in the Clinical Impairment Assessment (CIA)
大体时间：Baseline, 12, 24, 36, 48 weeks
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Measures the extent to which eating disorder symptoms impair functioning.
Higher scores indicate greater impairment.
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Baseline, 12, 24, 36, 48 weeks
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Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10)
大体时间：Baseline, 4, 8, 12, 24, 36, 48 weeks
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A 10-item measure of psychological flexibility as a multidimensional construct with subscales of Openness, Awareness and Engagement.
Higher scores indicate greater flexibility/adaptability.
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Baseline, 4, 8, 12, 24, 36, 48 weeks
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Change from Baseline in Daily Levels of Body Image Distress and Psychological Flexibility
大体时间：Baseline, 8 Weeks
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4 days of ecological momentary assessment of 1) distress/body-image distress 2) problematic behaviors to change body weight/shape, 3) general attempts to suppress/get rid of unwanted thoughts and feelings, 4) avoiding doing things because of concern about body, and 5) the ability to maintain adaptive distance and 6) orient to values.
Scaled items are on a Likert Scale 1=Not at All to 6=Very Much.
For items 1-4, higher scores are more problematic; For items 5-6, higher scores are more flexible adaptive.
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Baseline, 8 Weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline in Heart Rate when Viewing Emotional Film Clips
大体时间：Baseline, 8 weeks, 24 weeks
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Heart rate and heart rate variability measured with BIOPAC during the viewing of film clips (neutral, emotional-general, emotional-body-image related).
Increases indicate greater flexibility/adaptability.
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Baseline, 8 weeks, 24 weeks
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Change from Baseline in Cognitive Flexibility - Set-Shifting as assessed by the Wisconsin Card Sort Test (WCST)
大体时间：Baseline, 24 weeks
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68-item computerized version of the WCST using default settings; perseverative errors.
Decreases in errors indicates greater cognitive flexibility/adaptability.
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Baseline, 24 weeks
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Change from Baseline in Response Inhibition as assessed by Go/No-Go Task
大体时间：Baseline, 8 weeks, 24 weeks
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The Go/No-Go task measures ability to inhibit a response when signaled (among other outcomes), measured by commission errors (frequency of responding when signaled to not respond); Other indices include sensitivity (ability to discriminate go/no go trials) and reaction time to go stimuli.
Commission errors are of primary interest; decreases indicate reductions in impulsivity / improvement.
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Baseline, 8 weeks, 24 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline in the Body Dissatisfaction Subscale of the Eating Disorder Inventory-3
大体时间：Baseline, 8 Weeks
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EDI-3 Body Dissatisfaction (BD) Subscale, 10 items assessing contentment with specific body parts on a 6-point Likert scale (alternative mechanism of change).
Higher scores indicate greater symptomatology.
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Baseline, 8 Weeks
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Change from Baseline in Problematic Social Media Use as assessed by the Bergen Social Media Addiction Scale
大体时间：Baseline, 12 Weeks
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4-item scale assessing the extent to which social media use interfered or caused problems in life, with an additional item of hours of use (exploratory).
Decreases indicate improvement.
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Baseline, 12 Weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月15日
初级完成 (估计的)
2028年7月15日
研究完成 (估计的)
2028年7月31日
研究注册日期
首次提交
2026年6月1日
首先提交符合 QC 标准的
2026年6月1日
首次发布 (实际的)
2026年6月8日
研究记录更新
最后更新发布 (实际的)
2026年8月28日
上次提交的符合 QC 标准的更新
2026年8月26日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.