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RECRUITING Not applicable ClinicalTrials.gov

FlexED: Full Threshold ED Substudy

Sponsor: Duke University • ClinicalTrials.gov ID: NCT07732829

Registry updated: 2026-09-03
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Description

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.

Interventions

  • FlexED (Behavioral)
    Intervention consists of seven \~ 20-minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises.

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

Conditions

Eating Disorders Body Image

Locations

  • Duke University — Durham, North Carolina, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record