NCT07807774

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
23mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Aug 2026Jul 2028

Study Start

First participant enrolled

August 24, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2028

Expected
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

1.9 years

First QC Date

September 2, 2026

Last Update Submit

September 2, 2026

Conditions

Eating DisordersBody Image

Keywords

Body Image FlexibilityEating DisordersAcceptance and Commitment TherapyPsychological FlexibilityEarly Intervention

Outcome Measures

Primary Outcomes (5)

  • 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.

    Baseline, Week 4, Week 8, Week 12

  • 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, Week 4, Week 8, Week 12

  • 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.

    Baseline, Week 8, Week 12

  • 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.

    Baseline, Week 8, Week 12

  • Acceptability of the Intervention

    Session completion rates

    8 weeks

Study Arms (1)

FlexED

EXPERIMENTAL

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

Behavioral: FlexED

Interventions

FlexEDBEHAVIORAL

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

Eligibility Criteria

Age18 Years - 25 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Dottie R Mayo

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dottie R Mayo

CONTACT

919-668-1935drm72@duke.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 8, 2026

Study Start

August 24, 2026

Primary Completion (Estimated)

July 15, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

September 8, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

Data and data dictionaries will be made available at the time of publication.

Locations

US(1)