Eating DisordersNCT05609409

FlexED: A Digital, Gamified Early Intervention for Eating Disorders

A study testing FlexED in people with Eating Disorders and Body Image, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to test a new intervention for body-image distress to reduce eating disorder symptoms in young women and girls between the ages of 15-25 years old. Read more about this study

Who is it for?: Ages 15 to 25 years
Conditions the study is for: Eating Disorders, Body Image
What is being tested?: FlexED
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 2 Jul 2024to 7 May 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 25 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Female identified 15-25 years old
Weight Concerns Scale score of >47
Eating disorder behaviors with onset at current level <3 years

Who cannot join

Currently meet diagnostic criteria for anorexia or bulimia nervosa
Psychosis, substance use disorder or current suicidal ideation or self-harm.
Start or change in psychiatric medications within the past month.
NonEnglish Speaking.
Presents with other specified feeding or eating disorder (OSFED) that does not includes weight/shape concerns as a primary feature (e.g., Avoidant Restrictive Food Intake Disorder).

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University
Durham, North Carolina, 27705

Other trials in United States

About this study

The goal of this clinical trial is to test a new intervention for body-image distress to reduce eating disorder symptoms in young women and girls between the ages of 15-25 years old.

Participants complete up to 8 digital sessions using their mobile phone that include a character, story line and interactive exercises, games and digital rewards. Everyone in the study completes the intervention after different periods of time (2, 4 or 6 weeks) of completing assessments.

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 gaze, and reaction time to body-image related words and images, and test how long it takes to see change.

Read the detailed description

This multiple baseline experiment tests the impact of a digital, gamified early intervention for eating disorders on body-image psychological flexibility and assesses treatment dose. Twenty-four young women and girls with eating disorder (ED) symptoms are randomized to baseline duration between 2-6 weeks. Participants complete up to eight 20-30 minute sessions of a multimedia application using their mobile phone. Psychological flexibility is measured repeatedly using a multi-level, multi-dimensional assessment strategy of self-report and 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.

Conditions: Eating Disorders, Body Image
Being tested: FlexED
Keywords: Eating Disorders, Body Image Flexibility, Acceptance and Commitment Therapy, Psychological Flexibility, Online, Early Intervention
Medical subject headings: Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FlexEDBehavioural
Intervention consists of eight 20-30 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.

Study groups in NCT05609409
Study group	Role	What they receive
2-Week Baseline Duration	Experimental	2 weeks of assessment, then 8 weeks of intervention Receives: Behavioral: FlexED
4-Week Baseline Duration	Experimental	4 weeks of assessment, then 8 weeks of intervention Receives: Behavioral: FlexED
6-Week Baseline Duration	Experimental	6 weeks of assessment, then 8 weeks of intervention Receives: Behavioral: FlexED
Condensed schedule	Experimental	2 weeks of assessment, then 4 weeks of intervention (sessions twice a week) Receives: Behavioral: FlexED

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)
5-item measure assessing the ability to behave flexibly in the presence of negative thoughts and feelings about the body. Scores range from 5 to 35 with higher scores indicating greater flexibility.
Measured: Baseline, 6-8 weeks and 12 weeks
High Frequency Heart Rate Variability (HF-HRV)
Heart rate variability during provocation of body image distress; greater variability indicates an increased capacity to modulate arousal and distress. Indexed by HF Power ms^2 (Induction-Rest).
Measured: Baseline, 6-8 weeks, and 12 weeks
Change From Baseline in Biased Processing of Body Image Stimuli Relative to Neutral Stimuli
Biased processing of stimuli is assessed using an emotional Stroop task with body image and neutral stimuli. Improvements are indicated by decreases in bias score (decreases in difference in reaction time between evocative and neutral stimuli).
Measured: Baseline, 6-8 weeks, and 12 weeks
CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy)
10-item measure assessing psychological flexibility. Total scores range from 10 to 70 with higher scores indicating greater flexibility.
Measured: Baseline, 6-8 weeks, 12 weeks
Number of Eye Gaze Fixations on Pathology-relevant, Body-image Stimuli
Number of fixations on body and food related images presented during HF-HRV task.
Measured: Baseline, 6-8 weeks, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 20247 May 2025

First posted8 Nov 2022
Study start2 Jul 2024
Primary completion7 May 2025
Study completion7 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Eating DisordersStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Model description: Noncurrent Multiple Baseline Experimental Design where subjects will serve as their own control. Participants will be randomized to different baseline durations.
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05609409
Sponsor's protocol ID: Pro00111571
Status last verified: Aug 2026
First submitted: 1 Nov 2022
Last updated: 23 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Eating Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: FlexED: A Digital, Gamified Early Intervention for Eating Disorders
ClinicalTrials.gov ID: NCT05609409
Acronym / sponsor ID: Pro00111571
Conditions: Eating Disorders, Body Image
Keywords: Eating Disorders, Body Image Flexibility, Acceptance and Commitment Therapy, Psychological Flexibility, Online, Early Intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: University of Cyprus
Study start: 2 Jul 2024 (actual)
Primary completion: 7 May 2025 (actual)
Study completion: 7 May 2025 (actual)
First posted: 8 Nov 2022 (actual)
Results: Posted 6 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goal of this clinical trial is to test a new intervention for body-image distress to reduce eating disorder symptoms in young women and girls between the ages of 15-25 years old.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4
Model description: Noncurrent Multiple Baseline Experimental Design where subjects will serve as their own control. Participants will be randomized to different baseline durations.

Arm	Type	Receives
2-Week Baseline Duration	Experimental	Behavioral: FlexED2 weeks of assessment, then 8 weeks of intervention
4-Week Baseline Duration	Experimental	Behavioral: FlexED4 weeks of assessment, then 8 weeks of intervention
6-Week Baseline Duration	Experimental	Behavioral: FlexED6 weeks of assessment, then 8 weeks of intervention
Condensed schedule	Experimental	Behavioral: FlexED2 weeks of assessment, then 4 weeks of intervention (sessions twice a week)

Who may qualify

Ages: 15 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Female identified 15-25 years old
Weight Concerns Scale score of >47
Eating disorder behaviors with onset at current level <3 years

Key exclusion criteria (5 listed)

Currently meet diagnostic criteria for anorexia or bulimia nervosa
Psychosis, substance use disorder or current suicidal ideation or self-harm.
Start or change in psychiatric medications within the past month.
NonEnglish Speaking.
Presents with other specified feeding or eating disorder (OSFED) that does not includes weight/shape concerns as a primary feature (e.g., Avoidant Restrictive Food Intake Disorder).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FlexEDIntervention consists of eight 20-30 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.	Behavioural	2-Week Baseline Duration, 4-Week Baseline Duration, 6-Week Baseline Duration, Condensed schedule

Primary outcome

Change in Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)
Time frame: Baseline, 6-8 weeks and 12 weeks
5-item measure assessing the ability to behave flexibly in the presence of negative thoughts and feelings about the body. Scores range from 5 to 35 with higher scores indicating greater flexibility.
High Frequency Heart Rate Variability (HF-HRV)
Time frame: Baseline, 6-8 weeks, and 12 weeks
Heart rate variability during provocation of body image distress; greater variability indicates an increased capacity to modulate arousal and distress. Indexed by HF Power ms^2 (Induction-Rest).
Change From Baseline in Biased Processing of Body Image Stimuli Relative to Neutral Stimuli
Time frame: Baseline, 6-8 weeks, and 12 weeks
Biased processing of stimuli is assessed using an emotional Stroop task with body image and neutral stimuli. Improvements are indicated by decreases in bias score (decreases in difference in reaction time between evocative and neutral stimuli).
CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy)
Time frame: Baseline, 6-8 weeks, 12 weeks
10-item measure assessing psychological flexibility. Total scores range from 10 to 70 with higher scores indicating greater flexibility.
Number of Eye Gaze Fixations on Pathology-relevant, Body-image Stimuli
Time frame: Baseline, 6-8 weeks, 12 weeks
Number of fixations on body and food related images presented during HF-HRV task.

Results and safety

Results posted to the registry on 6 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2 Weeks No Intervention, Then 8 Weeks Intervention	6	5
4 Weeks No Intervention, Then 8 Weeks Intervention	7	7
6 Weeks No Intervention, Then 8 Weeks Intervention	7	5
2 Weeks No Intervention, Then 4 Weeks Intervention (Non-randomized Condensed Schedule)	4	3

Primary outcome: Change in Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)

Time frame: Baseline, 6-8 weeks and 12 weeks. Mean (Standard Deviation). Unit: Scale Score

Measure	FlexED Digital Intervention n = 18
Baseline	17.4 (6.8)
End-of-Treatment (Weeks 6-8)	20.5 (4.4)
Week 12 (~1 Month Post)	22.9 (5.9)

FlexED Digital Intervention: Mean Difference (Net): 0.24628
FlexED Digital Intervention: Mean Difference (Net): 0.33259
FlexED Digital Intervention: Minimal dose in weeks: 3.00872

Population analysed: N=20 participants were randomized to a baseline duration of 2, 4 or 6 weeks. N=2 participants randomized to a baseline duration were lost prior to starting treatment, leaving N=18 for analysis. Participants assigned to the condensed schedule were not included in primary analyses.

Primary outcome: High Frequency Heart Rate Variability (HF-HRV)

Time frame: Baseline, 6-8 weeks, and 12 weeks. Mean (Standard Deviation). Unit: ms^2

Measure	FlexED Digital Intervention n = 18
Baseline	-10.1 (689.3)
Weeks 6-8 (End-of-Treatment)	29.4 (552.4)
Week 12 (~1 Month post)	-351.0 (604.3)

FlexED Digital Intervention: Mean Difference (Net): -0.1831
FlexED Digital Intervention: Mean Difference (Net): -0.31027

Primary outcome: Change From Baseline in Biased Processing of Body Image Stimuli Relative to Neutral Stimuli

Time frame: Baseline, 6-8 weeks, and 12 weeks. Mean (Standard Deviation). Unit: milliseconds

Measure	FlexED Digital Intervention n = 18
Baseline	65.1 (91.8)
Weeks 6-8 (End-of-Treatment)	2.1 (61.0)
Week 12 (~1-Month Post)	31.2 (62.1)

FlexED Digital Intervention: Mean Difference (Net): -0.31171
FlexED Digital Intervention: Mean Difference (Net): -0.25408
FlexED Digital Intervention: Minimal dose in weeks: 1.64715

Primary outcome: CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy)

Time frame: Baseline, 6-8 weeks, 12 weeks. Mean (Standard Deviation). Unit: Scale Score

Measure	FlexED Digital Intervention n = 18
Baseline	32.4 (6.21)
Weeks 6-8 (End-of-Treatment)	36.3 (8.09)
Week 12 (~1 Month post)	38.2 (8.05)

FlexED Digital Intervention: Mean Difference (Net): 0.39371
FlexED Digital Intervention: Mean Difference (Net): 0.46026
FlexED Digital Intervention: Minimal dose in weeks: 1.27129

Adverse events

Time frame: Up to 14-18 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2 Weeks No Intervention, Then 8 Weeks Intervention	0 of 6 (0%)	0 of 6 (0%)	0 of 6
4 Weeks No Intervention, Then 8 Weeks Intervention	0 of 7 (0%)	0 of 7 (0%)	0 of 7
6 Weeks No Intervention, Then 8 Weeks Intervention	0 of 7 (0%)	0 of 7 (0%)	0 of 7
2 Weeks No Intervention, Then 4 Weeks Intervention	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FlexED in people with Eating Disorders and Body Image, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5) (time frame: Baseline, 6-8 weeks and 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05609409.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.