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Not yet recruiting NCT07632248

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

No phase Interventional Eating Disorders Body Image

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FlexED, Educational Control.
Who it may be relevant to
Registry conditions: Eating Disorders, Body Image. Basic parameters: 15 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ) [Time frame: Baseline, 4, 8, 12, 24, 36, 48 weeks]
  • Change from Baseline in the Body-Image Stroop Bias Score [Time frame: Baseline, 8 weeks, 24 weeks]
  • Change from Baseline in Eye Gaze Fixations - Body-Image Related Images [Time frame: Baseline, 8 weeks, 24 weeks]
  • Acceptability of the intervention [Time frame: 8 weeks]
  • Change from Baseline in Eating Disorder Examination (EDE) [Time frame: Baseline, 12 weeks, 24 weeks]
  • Change from Baseline in the Eating Disorder Examination - Questionnaire (EDE-Q) [Time frame: Baseline, 12, 24, 36, 48 weeks]
  • Change from Baseline in the Clinical Impairment Assessment (CIA) [Time frame: Baseline, 12, 24, 36, 48 weeks]
  • Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10) [Time frame: Baseline, 4, 8, 12, 24, 36, 48 weeks]
  • Change from Baseline in Daily Levels of Body Image Distress and Psychological Flexibility [Time frame: Baseline, 8 Weeks]
Secondary outcome measures (3)
  • Change from Baseline in Heart Rate when Viewing Emotional Film Clips [Time frame: Baseline, 8 weeks, 24 weeks]
  • Change from Baseline in Cognitive Flexibility - Set-Shifting as assessed by the Wisconsin Card Sort Test (WCST) [Time frame: Baseline, 24 weeks]
  • Change from Baseline in Response Inhibition as assessed by Go/No-Go Task [Time frame: Baseline, 8 weeks, 24 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Duke University — Durham

Identifiers

NCT: NCT07632248 · Pro00111571_1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗