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Not yet recruiting NCT07732829

FlexED: Full Threshold ED Substudy

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.
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

FlexED: A Digital Gamified Early Intervention for Eating Disorders

Overview

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.

Detailed description

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.

Interventions

  • Behavioral FlexED
    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 outcome measures

  • 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]
  • 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]
  • Change from Baseline in the Body-Image Stroop Bias Score [Time frame: Every 2 weeks to 8 weeks and 12 weeks]
  • Change from Baseline in Eye Gaze Fixations - Body-Image Related Images [Time frame: Every 2 weeks to 8 weeks and 12 weeks]
  • Change from Baseline in Heart Rate Variability when Viewing Body-Image Related Images [Time frame: Every 2 weeks to 8 weeks and 12 weeks]
  • Change from Baseline in Weight Concern Scale Score [Time frame: Baseline, 8 weeks and 12 weeks]
  • Change from Baseline in Eating Disorder Examination (EDE) [Time frame: Baseline and 12 weeks]

Eligibility criteria

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

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: NCT07732829 · Pro00111571_3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗