A Randomized Controlled Trial Testing a Digital, Gamified Early Intervention for Eating Disorders ("FlexED")
NCT07632248, Not applicable, Recruiting, Duke University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Randomized Controlled Trial Testing a Digital, Gamified Early Intervention for Eating Disorders ("FlexED") | ClinicalTrials.gov |
| NCT number | NCT07632248 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 128 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Duke University | ClinicalTrials.gov |
| Conditions | Eating Disorders, Body Image | ClinicalTrials.gov |
| Interventions | FlexED, Educational Control | ClinicalTrials.gov |
| First posted | 2026-06-08 | ClinicalTrials.gov |
| Last updated | 2026-08-28 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ) | Baseline, 4, 8, 12, 24, 36, 48 weeks | Self-report measure of body-image psychological flexibility. The measure consists of 13 (full measure) or 5 (short measure) items that ask about the degree to which thoughts and feelings about the body interfere with living. Higher scores indicate greater flexibility/adaptability. | ClinicalTrials.gov |
| Primary | Change from Baseline in the Body-Image Stroop Bias Score | Baseline, 8 weeks, 24 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. | ClinicalTrials.gov |
| Primary | Change from Baseline in Eye Gaze Fixations - Body-Image Related Images | Baseline, 8 weeks, 24 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. | ClinicalTrials.gov |
| Primary | Acceptability of the intervention | 8 weeks | Enrollment targets met, \>70% of participants that start the intervention will complete \>80%, \>70% of participants and sessions will have user inputs indicating engagement. | ClinicalTrials.gov |
| Primary | Change from Baseline in Eating Disorder Examination (EDE) | Baseline, 12 weeks, 24 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. | ClinicalTrials.gov |
| Primary | Change from Baseline in the Eating Disorder Examination - Questionnaire (EDE-Q) | Baseline, 12, 24, 36, 48 weeks | 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. | ClinicalTrials.gov |
| Primary | Change from Baseline in the Clinical Impairment Assessment (CIA) | Baseline, 12, 24, 36, 48 weeks | Measures the extent to which eating disorder symptoms impair functioning. Higher scores indicate greater impairment. | ClinicalTrials.gov |
| Primary | Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10) | Baseline, 4, 8, 12, 24, 36, 48 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. | ClinicalTrials.gov |
| Primary | Change from Baseline in Daily Levels of Body Image Distress and Psychological Flexibility | Baseline, 8 Weeks | 4 days of ecological momentary assessment of 1) distress/body-image distress 2) problematic behaviors to change body weight/shape, 3) general attempts to suppress/get rid of unwanted thoughts and feelings, 4) avoiding doing things because of concern about body, and 5) the ability to maintain adaptive distance and 6) orient to values. Scaled items are on a Likert Scale 1=Not at All to 6=Very Much. For items 1-4, higher scores are more problematic; For items 5-6, higher scores are more flexible adaptive. | ClinicalTrials.gov |
| Secondary | Change from Baseline in Heart Rate when Viewing Emotional Film Clips | Baseline, 8 weeks, 24 weeks | Heart rate and heart rate variability measured with BIOPAC during the viewing of film clips (neutral, emotional-general, emotional-body-image related). Increases indicate greater flexibility/adaptability. | ClinicalTrials.gov |
| Secondary | Change from Baseline in Cognitive Flexibility - Set-Shifting as assessed by the Wisconsin Card Sort Test (WCST) | Baseline, 24 weeks | 68-item computerized version of the WCST using default settings; perseverative errors. Decreases in errors indicates greater cognitive flexibility/adaptability. | ClinicalTrials.gov |
| Secondary | Change from Baseline in Response Inhibition as assessed by Go/No-Go Task | Baseline, 8 weeks, 24 weeks | The Go/No-Go task measures ability to inhibit a response when signaled (among other outcomes), measured by commission errors (frequency of responding when signaled to not respond); Other indices include sensitivity (ability to discriminate go/no go trials) and reaction time to go stimuli. Commission errors are of primary interest; decreases indicate reductions in impulsivity / improvement. | ClinicalTrials.gov |
| Other | Change from Baseline in the Body Dissatisfaction Subscale of the Eating Disorder Inventory-3 | Baseline, 8 Weeks | EDI-3 Body Dissatisfaction (BD) Subscale, 10 items assessing contentment with specific body parts on a 6-point Likert scale (alternative mechanism of change). Higher scores indicate greater symptomatology. | ClinicalTrials.gov |
| Other | Change from Baseline in Problematic Social Media Use as assessed by the Bergen Social Media Addiction Scale | Baseline, 12 Weeks | 4-item scale assessing the extent to which social media use interfered or caused problems in life, with an additional item of hours of use (exploratory). Decreases indicate improvement. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Emotional Stroop Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Card Sorting Test (Berg) | Secondary outcome | ConductCognition |
| Go/No-Go Task | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)