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

NCT07632248 | Not Yet Recruiting

• 1 other identifier: Pro00111571_1
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Eating Disorders; Body Image

Keywords

Eating Disorders; Body Image Flexibility; Acceptance and Commitment Therapy; Psychological Flexibility; Early Intervention

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (3)

• Change from Baseline in Heart Rate when Viewing Emotional Film Clips

  Baseline, 8 weeks, 24 weeks

• Change from Baseline in Cognitive Flexibility - Set-Shifting as assessed by the Wisconsin Card Sort Test (WCST)

  Baseline, 24 weeks

• Change from Baseline in Response Inhibition as assessed by Go/No-Go Task

  Baseline, 8 weeks, 24 weeks

Other Outcomes (2)

• Change from Baseline in the Body Dissatisfaction Subscale of the Eating Disorder Inventory-3

  Baseline, 8 Weeks

• Change from Baseline in Problematic Social Media Use as assessed by the Bergen Social Media Addiction Scale

  Baseline, 12 Weeks

Study Arms (2)

"FlexED"

EXPERIMENTAL

Seven 20-minute sessions of an online, multimedia application that teaches psychological flexibility with body-image related thoughts and feelings.

Behavioral: FlexED

Educational Control

ACTIVE COMPARATOR

Seven 20-minute online education sessions about eating disorders.

Behavioral: Educational Control

Interventions

FlexED BEHAVIORAL

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.

"FlexED"

Educational Control BEHAVIORAL

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.

Educational Control

Eligibility Criteria

• Age: 15 Years - 25 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Rhonda M Merwin, Ph.D.

CONTACT

919-681-7231; rhonda.merwin@duke.edu

Hallie B Wolfe

CONTACT

hallie.wolfe@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)