Recruiting

FlexED

Sponsor:

Duke University

Code:

NCT07807774

Conditions

Eating Disorders

Body Image

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

Interventions

FlexED

Study Details

Brief 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.

Conditions

Eating Disorders

Body Image

Study ID

NCT07807774

Start date

Aug 24, 2026

Status verified date

Sep, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FlexED

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

Interventions

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.

Primary outcome measure

  • Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)-5 [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]
  • Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10) [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]
  • Change in Weight Concern Scale Score [ Time Frame: Baseline, Week 8, Week 12 ]
  • Change from Baseline in the Eating Disorder Examination - Questionnaire Short Form (EDE-Q-SF) [ Time Frame: Baseline, Week 8, Week 12 ]
  • Acceptability of the Intervention [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Dottie R Mayo

919-668-1935drm72@duke.edu

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Dottie R Mayo

919-668-1935drm72@duke.edu

Principal Investigator:

Rhonda M Merwin, PhD

More Information

Sponsor

Duke University

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-09-08.