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Completed

NCT Number: NCT05609409

FlexED: A Digital, Gamified Early Intervention for Eating Disorders

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.

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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

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female identified 15-25 years old
  • Weight Concerns Scale score of >47
  • Eating disorder behaviors with onset at current level <3 years

Exclusion criteria

  • 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).

Treatment and study plan

FlexED

Behavioral

Intervention consists of eight 20-30 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 in Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)

    Time frame: 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.

  2. High Frequency Heart Rate Variability (HF-HRV)

    Time frame: 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).

  3. Change From Baseline in Biased Processing of Body Image Stimuli Relative to Neutral Stimuli

    Time frame: 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).

  4. CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy)

    Time frame: 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.

  5. Number of Eye Gaze Fixations on Pathology-relevant, Body-image Stimuli

    Time frame: Baseline, 6-8 weeks, 12 weeks

    Number of fixations on body and food related images presented during HF-HRV task.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • University of Cyprus

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2022
Registry last updated
Jul 6, 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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