CClinicalTrials.gg
RecruitingNCT07807774Updated Sep 8, 2026

FlexED: National Substudy

An interventional study of FlexED in Eating Disorders and Body Image, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Duke University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 25 Years
Sex
All
01

Study summary

The purpose of this study is to test the feasibility of disseminating an intervention broadly. "FlexED" is a digital gamified intervention targeting 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 complete seven 20-minute sessions of the intervention using their smartphone over about 8 weeks. Participants also complete questionnaires bi-weekly as they go through the intervention. A final measurement is taken one month after the last digital intervention session. These surveys are all conducted online. Participants are in the study for up to 12 weeks.

02

Conditions studied

  • Eating Disorders
  • Body Image

Keywords

  • Body Image Flexibility
  • Eating Disorders
  • Acceptance and Commitment Therapy
  • Psychological Flexibility
  • Early Intervention
03

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Female between the age of 18-25 years old.

Exclusion criteria

Exclusion Criteria:

  • Non-English speaking
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    FlexED

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

    Behavioral: FlexED

Interventions

  • BehavioralFlexED

    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.

05

What researchers measure

Primary outcomes

  1. Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5

    Self-report measure of body-image psychological flexibility. The measure consists of 5 items that ask about the degree to which thoughts and feelings about the body interfere with living. Higher scores indicate greater flexibility/adaptability.

    Time frame: Baseline, Week 4, Week 8, Week 12

  2. 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.

    Time frame: Baseline, Week 4, Week 8, Week 12

  3. Change in Weight Concern Scale Score

    5-item measure of weight concerns (worry about weight, fear of weight gain, dieting history, importance of weight, fear of fatness). Elevated scores have been associated with the development of eating disorders.

    Time frame: Baseline, Week 8, Week 12

  4. Change from Baseline in the Eating Disorder Examination - Questionnaire Short Form (EDE-Q-SF)

    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.

    Time frame: Baseline, Week 8, Week 12

  5. Acceptability of the Intervention

    Session completion rates

    Time frame: 8 weeks

06

Study locations

1 of 1 sites recruiting
  • Duke University Medical Center
    Durham, North Carolina 27705, United States
    • Dottie R Mayo · Contact · drm72@duke.edu · 919-668-1935
    • Rhonda M Merwin, PhD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — Data and data dictionaries will be made available at the time of publication.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07807774
Lead sponsor
Duke University
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Sep 8, 2026
Start date
Aug 24, 2026
Primary completion
Jul 15, 2028 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Sep 8, 2026

Study contacts

Dottie R Mayo
Contact
drm72@duke.edu
919-668-1935
Dottie R Mayo
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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