Eating DisordersNCT07732829
FlexED: Full Threshold ED Substudy
A study testing FlexED in people with Eating Disorders and Body Image, run by Duke University at 1 site in United States.
Trial summary
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). 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
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 age 15-25 years
- Weight Concerns Scale score of >=47
- Meets diagnostic criteria for an eating disorder based on the DSM-5
Who cannot join
- Psychosis, substance use disorder, or current suicidal ideation or self-harm
- Start or change in psychiatric medications within the past month
- Non-English speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27705
Dottie Mayo, 919-668-1935, dottie.mayo@duke.edu
Rhonda M Merwin, PhD
About this study
Official title: FlexED: A Digital Gamified Early Intervention for Eating Disorders
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.
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 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.
- Conditions
- Eating Disorders, Body Image
- Being tested
- FlexED
- Keywords
- Body Image Flexibility, Eating Disorders, Acceptance and Commitment Therapy, Psychological Flexibility, 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 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.
| Study group | Role | What they receive |
|---|---|---|
| 2-Week Baseline Duration | Experimental | baseline 0, 2 additional weeks of assessment, then 8 weeks of intervention Receives: Behavioral: FlexED |
| 4-Week Baseline Duration | Experimental | baseline 0, 4 additional weeks of assessment, then 8 weeks of intervention Receives: Behavioral: FlexED |
| 6-Week Baseline Duration | Experimental | baseline 0, 6 additional weeks of assessment, then 8 weeks of intervention Receives: Behavioral: FlexED |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
A 10-item measure of psychological flexibility as a multidimensional construct with subscales of Openness, Awareness and Engagement. Higher scores indicate greater flexibility/adaptability.
Measured: Every 2 weeks to 8 weeks and 12 weeks
Change from Baseline in the Body-Image Stroop Bias Score
Change in reaction time to body-related versus neutral words in an emotional stroop paradigm. In this paradigm, participants identify the color of the written word as quickly as possible. Differences in reaction time between emotionally relevant words and neutral words is calculated as a bias score. Lower bias scores indicate improvement.
Measured: Every 2 weeks to 8 weeks and 12 weeks
Change from Baseline in Eye Gaze Fixations - Body-Image Related Images
Change in the number of fixations on body-image related images, including idealized bodies, overweight bodies, body-weight measurement, and images of binge eating and body-related distress. Fewer fixations indicate improvement.
Measured: Every 2 weeks to 8 weeks and 12 weeks
Change from Baseline in Heart Rate Variability when Viewing Body-Image Related Images
Heart rate variability measured with BIOPAC during the viewing of body-image related images, including idealized bodies, overweight bodies, body-weight measurement, and images of binge eating and body-related distress. Increases indicate greater flexibility/adaptability.
Measured: Every 2 weeks to 8 weeks and 12 weeks
Change from Baseline 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.
Measured: Baseline, 8 weeks and 12 weeks
Change from Baseline in Eating Disorder Examination (EDE)
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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Sep 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Model description
- Noncurrent Multiple Baseline Experimental Design where subjects will serve as their own control. Participants will be randomized to different baseline durations.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732829
- Sponsor's protocol ID
- Pro00111571_3
- Status last verified
- Sep 2026
- First submitted
- 19 Jul 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 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
- NCT07732829
- Acronym / sponsor ID
- Pro00111571_3
- Conditions
- Eating Disorders, Body Image
- Keywords
- Body Image Flexibility, Eating Disorders, Acceptance and Commitment Therapy, Psychological Flexibility, Early Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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: FlexEDbaseline 0, 2 additional weeks of assessment, then 8 weeks of intervention |
| 4-Week Baseline Duration | Experimental | Behavioral: FlexEDbaseline 0, 4 additional weeks of assessment, then 8 weeks of intervention |
| 6-Week Baseline Duration | Experimental | Behavioral: FlexEDbaseline 0, 6 additional weeks of assessment, then 8 weeks of intervention |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Female age 15-25 years
- Weight Concerns Scale score of >=47
- Meets diagnostic criteria for an eating disorder based on the DSM-5
Key exclusion criteria (3 listed)
- Psychosis, substance use disorder, or current suicidal ideation or self-harm
- Start or change in psychiatric medications within the past month
- Non-English speaking
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 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. | Behavioural | 2-Week Baseline Duration, 4-Week Baseline Duration, 6-Week Baseline Duration |
Primary outcome
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
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.
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
A 10-item measure of psychological flexibility as a multidimensional construct with subscales of Openness, Awareness and Engagement. Higher scores indicate greater flexibility/adaptability.
Change from Baseline in the Body-Image Stroop Bias Score
Time frame: Every 2 weeks to 8 weeks and 12 weeks
Change in reaction time to body-related versus neutral words in an emotional stroop paradigm. In this paradigm, participants identify the color of the written word as quickly as possible. Differences in reaction time between emotionally relevant words and neutral words is calculated as a bias score. Lower bias scores indicate improvement.
Change from Baseline in Eye Gaze Fixations - Body-Image Related Images
Time frame: Every 2 weeks to 8 weeks and 12 weeks
Change in the number of fixations on body-image related images, including idealized bodies, overweight bodies, body-weight measurement, and images of binge eating and body-related distress. Fewer fixations indicate improvement.
Change from Baseline in Heart Rate Variability when Viewing Body-Image Related Images
Time frame: Every 2 weeks to 8 weeks and 12 weeks
Heart rate variability measured with BIOPAC during the viewing of body-image related images, including idealized bodies, overweight bodies, body-weight measurement, and images of binge eating and body-related distress. Increases indicate greater flexibility/adaptability.
Change from Baseline in Weight Concern Scale Score
Time frame: Baseline, 8 weeks and 12 weeks
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.
Change from Baseline in Eating Disorder Examination (EDE)
Time frame: Baseline and 12 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- 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.
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 3 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: looking for participants now, as of the sponsor's last update on 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rhonda Merwin, PhD (919-681-7231, rhonda.merwin@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2026.