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NCT Number: NCT07732829

FlexED: Full Threshold ED Substudy

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.

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Key information

Conditions

Eating Disorders Body Image Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

Dottie Mayo

CONTACT

[email protected]

919-668-1935

Rhonda M Merwin, PhD

PRINCIPAL_INVESTIGATOR

About this study

This multiple baseline experiment tests the impact of a digital, gamified early intervention for eating disorders on body-image psychological flexibility eating disorder symptoms. Up to 6 young women and girls between the ages of 15-25 with full threshold eating disorder symptoms or diagnoses will complete an initial baseline assessment, and then be assigned to different assessment (baseline) periods ranging from 2-6 weeks. They will then complete 7 fully digital sessions over 8 weeks at home using their mobile phone. Psychological flexibility will be measured repeatedly via self-report and multi-level, multi-dimensional 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. Eating disorder symptoms will also be assessed pre and post intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5

    Time frame: Every 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.

  2. Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10)

    Time frame: 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.

  3. Change from Baseline in the Body-Image Stroop Bias Score

    Time frame: Every 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.

  4. Change from Baseline in Eye Gaze Fixations - Body-Image Related Images

    Time frame: Every 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.

  5. Change from Baseline in Heart Rate Variability when Viewing Body-Image Related Images

    Time frame: Every 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.

  6. Change from Baseline in Weight Concern Scale Score

    Time frame: Baseline, 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.

  7. Change from Baseline in Eating Disorder Examination (EDE)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rhonda Merwin, PhD

CONTACT

[email protected]

919-681-7231

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

FlexED: A Digital Gamified Early Intervention for Eating Disorders

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 29, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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