FlexED: Digital Intervention for Eating Disorders
This study, called FlexED, is testing a new digital program designed to help young women with eating disorders. The program, also called FlexED, uses Acceptance and Commitment Therapy (ACT) to help you respond more flexibly to difficult thoughts and feelings about your body. You'll use your mobile phone to complete seven sessions, each about 20 minutes long, which include a story, interactive exercises, and games. Researchers want to see if this program can reduce eating disorder symptoms and improve how you cope with body image distress. To join, you must be a female between 15 and 25 years old, have certain weight concerns, and meet the diagnostic criteria for an eating disorder. You cannot participate if you have psychosis, substance use disorder, current suicidal thoughts, or have recently started or changed psychiatric medications. Success in this study means seeing improvements in your body image flexibility and eating disorder symptoms.
- Study design
- This is an interventional study with an unclear status, planning to enroll up to 6 young women. It uses a multiple baseline experiment design.
- What's involved
- You will complete an initial assessment, followed by 2-6 weeks of baseline assessments. Then, you will complete 7 fully digital sessions over 8 weeks using your mobile phone at home.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be measured every 2 weeks up to 8 weeks, and then again at 12 weeks after starting the intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
FlexED: Full Threshold ED Substudy
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5Every 2 weeks to 8 weeks and 12 weeks
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)Every 2 weeks to 8 weeks and 12 weeks
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 from Baseline in the Body-Image Stroop Bias ScoreEvery 2 weeks to 8 weeks and 12 weeks
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.
- Change from Baseline in Eye Gaze Fixations - Body-Image Related ImagesEvery 2 weeks to 8 weeks and 12 weeks
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.
- Change from Baseline in Heart Rate Variability when Viewing Body-Image Related ImagesEvery 2 weeks to 8 weeks and 12 weeks
Heart rate variability measured with BIOPAC during the viewing of body-image related images, including idealized bodies, overweight bodies, body-weight measurement, and images of binge eating and body-related distress. Increases indicate greater flexibility/adaptability.
- Change from Baseline in Weight Concern Scale ScoreBaseline, 8 weeks and 12 weeks
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 Eating Disorder Examination (EDE)Baseline and 12 weeks
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.