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NCT07732829
FlexED: Full Threshold ED Substudy
Conditions: Eating Disorders, Body Image
Sex: All
Ages: 15 Years – 25 Years
Healthy volunteers: No
Phase: NA
Enrollment: 6
Sponsor: Duke University
Location: Duke University Durham North Carolina
Summary
The purpose of this study is to test whether a new digital intervention decreases eating disorder symptoms in young women with eating disorders by changing how they experience thoughts and feelings about their body. The digital intervention is based on Acceptance and Commitment Therapy (ACT). Participants complete up to 7 digital intervention sessions using their mobile phone that include a character, story line and interactive exercises, games and digital rewards.
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 movements, and reaction time to body-image related words and images, and examine changes in eating disorder symptoms before and after intervention.
Eligibility Criteria
Inclusion Criteria:
* Female age 15-25 years
* Weight Concerns Scale score of \>=47
* Meets diagnostic criteria for an eating disorder based on the DSM-5
Exclusion Criteria:
* Psychosis, substance use disorder, or current suicidal ideation or self-harm
* Start or change in psychiatric medications within the past month
* Non-English speaking
Source: ClinicalTrials.gov (NCT07732829). StuddyBuddy aggregates publicly available trial information.