A Study Testing a Digital, Gamified Early Intervention for Eating Disorders ("FlexED")

A Randomized Controlled Trial Testing Mechanism Engagement and Clinical Impact of FlexED: A Digital, Gamified Early Intervention for Eating Disorders

The goal of this clinical trial is to test whether a new digital intervention decreases eating disorder symptoms in young women and girls at risk by changing how they experience thoughts and feelings about their body.

The digital intervention is based on Acceptance and Commitment Therapy (ACT). Participants will be randomly assigned (like a coin toss) to either the new digital intervention or education modules completed online.

The main questions are:

Does the digital intervention change how participants experience thoughts and feelings about their body or how they react to eating disorder triggers (e.g., images of idealized bodies)? Do these changes lead to decreases in eating disorder symptoms? Is the intervention acceptable and at the right dose?

Participants will:

Complete seven brief digital sessions over about 8 weeks. Complete interviews, surveys and lab assessments of reaction to body-related words and images.

Participants are followed for about 1 year.

Study Overview

• Status: Not yet recruiting
• Conditions: Body Image; Eating Disorders
• Intervention / Treatment: Behavioral: FlexED; Behavioral: Educational Control

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rhonda M Merwin, Ph.D.; Phone Number: 919-681-7231; Email: rhonda.merwin@duke.edu
• Study Contact Backup: Name: Hallie B Wolfe; Email: hallie.wolfe@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University
      • Principal Investigator: Rhonda M Merwin, Ph.D.
      • Contact: Hallie B Wolfe; Phone Number: 919-668-8696; Email: hallie.wolfe@duke.edu
      • Contact: Dottie Mayo; Phone Number: 919-668-1935; Email: dottie.mayo@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female between the age of 15-25 years old.
• Weight Concerns Scale score of >=47.
• Endorses one or more eating disorder behaviors (e.g., extreme dieting or exercise, subjective or objective binge eating, purging behaviors).

Exclusion Criteria:

• Currently meets the DSM-5 diagnostic criteria for full threshold anorexia nervosa, bulimia nervosa or binge eating disorder, or for an eating or feeding disorder that does not include body-image or weight related distress and is not the focus of study (e.g., ARFID, PICA) or a past diagnosis of one of these disorders.
• Change in psychotropic medications in the past month.
• Active suicidal ideation, current substance use disorder or diagnosed psychotic disorder.
• Bipolar disorder not being treated with medication.
• Currently in treatment for an eating disorder.
• Non-English speaking.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "FlexED"; Seven 20-minute sessions of an online, multimedia application that teaches psychological flexibility with body-image related thoughts and feelings.	Behavioral: FlexED; Intervention consists of seven 20-minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn psychological flexibility skills for body-image distress by completing interactive exercises and games with a relatable character and story line and receive rewards that reinforce learning.
Active Comparator: Educational Control; Seven 20-minute online education sessions about eating disorders.	Behavioral: Educational Control; Intervention consists of seven digital online sessions of education about eating disorders and body image. Participants read information about how eating disorders develop and their impact on health and well-being and body image, watch videos and complete quizzes to check knowledge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)	Self-report measure of body-image psychological flexibility. The measure consists of 13 (full measure) or 5 (short measure) items that ask about the degree to which thoughts and feelings about the body interfere with living. Higher scores indicate greater flexibility/adaptability.	Baseline, 4, 8, 12, 24, 36, 48 weeks
Change from Baseline in the Body-Image Stroop Bias Score	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.	Baseline, 8 weeks, 24 weeks
Change from Baseline in Eye Gaze Fixations - Body-Image Related Images	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.	Baseline, 8 weeks, 24 weeks
Acceptability of the intervention	Enrollment targets met, >70% of participants that start the intervention will complete >80%, >70% of participants and sessions will have user inputs indicating engagement.	8 weeks
Change from Baseline in Eating Disorder Examination (EDE)	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.	Baseline, 12 weeks, 24 weeks
Change from Baseline in the Eating Disorder Examination - Questionnaire (EDE-Q)	Questionnaire format of the 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.	Baseline, 12, 24, 36, 48 weeks
Change from Baseline in the Clinical Impairment Assessment (CIA)	Measures the extent to which eating disorder symptoms impair functioning. Higher scores indicate greater impairment.	Baseline, 12, 24, 36, 48 weeks
Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10)	A 10-item measure of psychological flexibility as a multidimensional construct with subscales of Openness, Awareness and Engagement. Higher scores indicate greater flexibility/adaptability.	Baseline, 4, 8, 12, 24, 36, 48 weeks
Change from Baseline in Daily Levels of Body Image Distress and Psychological Flexibility	4 days of ecological momentary assessment of 1) distress/body-image distress 2) problematic behaviors to change body weight/shape, 3) general attempts to suppress/get rid of unwanted thoughts and feelings, 4) avoiding doing things because of concern about body, and 5) the ability to maintain adaptive distance and 6) orient to values. Scaled items are on a Likert Scale 1=Not at All to 6=Very Much. For items 1-4, higher scores are more problematic; For items 5-6, higher scores are more flexible adaptive.	Baseline, 8 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Heart Rate when Viewing Emotional Film Clips	Heart rate and heart rate variability measured with BIOPAC during the viewing of film clips (neutral, emotional-general, emotional-body-image related). Increases indicate greater flexibility/adaptability.	Baseline, 8 weeks, 24 weeks
Change from Baseline in Cognitive Flexibility - Set-Shifting as assessed by the Wisconsin Card Sort Test (WCST)	68-item computerized version of the WCST using default settings; perseverative errors. Decreases in errors indicates greater cognitive flexibility/adaptability.	Baseline, 24 weeks
Change from Baseline in Response Inhibition as assessed by Go/No-Go Task	The Go/No-Go task measures ability to inhibit a response when signaled (among other outcomes), measured by commission errors (frequency of responding when signaled to not respond); Other indices include sensitivity (ability to discriminate go/no go trials) and reaction time to go stimuli. Commission errors are of primary interest; decreases indicate reductions in impulsivity / improvement.	Baseline, 8 weeks, 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the Body Dissatisfaction Subscale of the Eating Disorder Inventory-3	EDI-3 Body Dissatisfaction (BD) Subscale, 10 items assessing contentment with specific body parts on a 6-point Likert scale (alternative mechanism of change). Higher scores indicate greater symptomatology.	Baseline, 8 Weeks
Change from Baseline in Problematic Social Media Use as assessed by the Bergen Social Media Addiction Scale	4-item scale assessing the extent to which social media use interfered or caused problems in life, with an additional item of hours of use (exploratory). Decreases indicate improvement.	Baseline, 12 Weeks

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy; Early Intervention; Eating Disorders; Body Image Flexibility; Psychological Flexibility
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Feeding and Eating Disorders
• Other Study ID Numbers: Pro00111571_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared in the NIMH National Data Archive (NDA).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No