FlexED: A Digital, Gamified Early Intervention for Eating Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in High Frequency Heart Rate Variability (HF-HRV)
研究概览
简要总结
The goal of this clinical trial is to test a new intervention for body-image distress to reduce eating disorder symptoms in young women and girls between the ages of 15-25 years old.
Participants complete up to 8 digital sessions using their mobile phone that include a character, story line and interactive exercises, games and digital rewards. Everyone in the study completes the intervention after different periods of time (2, 4 or 6 weeks) of completing assessments.
Researchers will examine the impact of the intervention on participants ability to respond flexibly to body-image distress or triggers, measuring things like heart rate, eye gaze, and reaction time to body-image related words and images, and test how long it takes to see change.
详细描述
This multiple baseline experiment tests the impact of a digital, gamified early intervention for eating disorders on body-image psychological flexibility and assesses treatment dose. Twenty-four young women and girls with eating disorder (ED) symptoms are randomized to baseline duration between 2-6 weeks. Participants complete up to eight 20-30 minute sessions of a multimedia application using their mobile phone. Psychological flexibility is measured repeatedly using a multi-level, multi-dimensional assessment strategy of self-report and lab-based tasks assessing flexibility in cognition, affect and attention with body-image related stimuli during the baseline and treatment phases to estimate treatment effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female identified 15-25 years old
- •Weight Concerns Scale score of >47
- •Eating disorder behaviors with onset at current level <3 years
排除标准
- •Currently meet diagnostic criteria for anorexia or bulimia nervosa
- •Psychosis, substance use disorder or current suicidal ideation or self-harm.
- •Start or change in psychiatric medications within the past month.
- •NonEnglish Speaking.
- •Presents with other specified feeding or eating disorder (OSFED) that does not includes weight/shape concerns as a primary feature (e.g., Avoidant Restrictive Food Intake Disorder).
结局指标
主要结局
Change in High Frequency Heart Rate Variability (HF-HRV)
时间窗: Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks
Heart rate variability during provocation of body image distress; greater variability indicates an increased capacity to modulate arousal and distress.
Change in body image flexibility as indexed by the Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)
时间窗: Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks
5-item measure assessing the ability to behave flexibly in the presence of negative thoughts and feelings about the body. Scores range from 5 to 35 with higher scores indicating greater flexibility.
Change in biased processing of body image stimuli relative to neutral stimuli
时间窗: Baseline, 1, 2, 3, 4, 6, 8, 10, 12, and 16 weeks
Biased processing of stimuli is assessed using an emotional Stroop task with body image and neutral stimuli. Improvements are indicated by changes in reaction time and fewer errors.
Change in Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)
时间窗: Baseline, 6-8 weeks and 12 weeks
5-item measure assessing the ability to behave flexibly in the presence of negative thoughts and feelings about the body. Scores range from 5 to 35 with higher scores indicating greater flexibility.
High Frequency Heart Rate Variability (HF-HRV)
时间窗: Baseline, 6-8 weeks, and 12 weeks
Heart rate variability during provocation of body image distress; greater variability indicates an increased capacity to modulate arousal and distress. Indexed by HF Power ms\^2 (Induction-Rest).
Change From Baseline in Biased Processing of Body Image Stimuli Relative to Neutral Stimuli
时间窗: Baseline, 6-8 weeks, and 12 weeks
Biased processing of stimuli is assessed using an emotional Stroop task with body image and neutral stimuli. Improvements are indicated by decreases in bias score (decreases in difference in reaction time between evocative and neutral stimuli).
CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy)
时间窗: Baseline, 6-8 weeks, 12 weeks
10-item measure assessing psychological flexibility. Total scores range from 10 to 70 with higher scores indicating greater flexibility.
Number of Eye Gaze Fixations on Pathology-relevant, Body-image Stimuli
时间窗: Baseline, 6-8 weeks, 12 weeks
Number of fixations on body and food related images presented during HF-HRV task.
次要结局
未报告次要终点