A Randomized Controlled Trial Testing a Digital, Gamified Early Intervention for Eating Disorders ("FlexED")
26 août 2026 mis à jour par: Duke University
A Randomized Controlled Trial Testing Mechanism Engagement and Clinical Impact of FlexED: A Digital, Gamified Early Intervention for Eating Disorders
The goal of this clinical trial is to test whether a new digital intervention decreases 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 will be randomly assigned (like a coin toss) to either the new digital intervention or education modules completed online.
The main questions are:
Does the digital intervention change how participants experience thoughts and feelings about their body or how they react to eating disorder triggers (e.g., images of idealized bodies)? Do these changes lead to decreases in eating disorder symptoms? Is the intervention acceptable and at the right dose?
Participants will:
Complete seven brief digital sessions over about 8 weeks. Complete interviews, surveys and lab assessments of reaction to body-related words and images.
Participants are followed for about 1 year.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
128
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Rhonda M Merwin, Ph.D.
- Numéro de téléphone: 919-681-7231
- E-mail: rhonda.merwin@duke.edu
Sauvegarde des contacts de l'étude
- Nom: Dottie R Mayo
- Numéro de téléphone: 919-668-1935
- E-mail: drm72@duke.edu
Lieux d'étude
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North Carolina
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Durham, North Carolina, États-Unis, 27705
- Recrutement
- Duke University
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Chercheur principal:
- Rhonda M Merwin, Ph.D.
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Contact:
- Dottie R Mayo
- Numéro de téléphone: 919-668-1935
- E-mail: drm72@duke.edu
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Female between the age of 15-25 years old.
- Weight Concerns Scale score of >=47.
- Endorses one or more eating disorder behaviors (e.g., extreme dieting or exercise, subjective or objective binge eating, purging behaviors).
Exclusion Criteria:
- Currently meets the DSM-5 diagnostic criteria for full threshold anorexia nervosa, bulimia nervosa or binge eating disorder, or for an eating or feeding disorder that does not include body-image or weight related distress and is not the focus of study (e.g., ARFID, PICA) or a past diagnosis of one of these disorders.
- Change in psychotropic medications in the past month.
- Active suicidal ideation, current substance use disorder or diagnosed psychotic disorder.
- Bipolar disorder not being treated with medication.
- Currently in treatment for an eating disorder.
- Non-English speaking.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: "FlexED"
Seven 20-minute sessions of an online, multimedia application that teaches psychological flexibility with body-image related thoughts and feelings.
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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.
|
|
Comparateur actif: Educational Control
Seven 20-minute online education sessions about eating disorders.
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Intervention consists of seven digital online sessions of education about eating disorders and body image.
Participants read information about how eating disorders develop and their impact on health and well-being and body image, watch videos and complete quizzes to check knowledge.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)
Délai: 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.
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Baseline, 4, 8, 12, 24, 36, 48 weeks
|
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Change from Baseline in the Body-Image Stroop Bias Score
Délai: Baseline, 8 weeks, 24 weeks
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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.
|
Baseline, 8 weeks, 24 weeks
|
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Change from Baseline in Eye Gaze Fixations - Body-Image Related Images
Délai: Baseline, 8 weeks, 24 weeks
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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.
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Baseline, 8 weeks, 24 weeks
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Acceptability of the intervention
Délai: 8 weeks
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Enrollment targets met, >70% of participants that start the intervention will complete >80%, >70% of participants and sessions will have user inputs indicating engagement.
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8 weeks
|
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Change from Baseline in Eating Disorder Examination (EDE)
Délai: Baseline, 12 weeks, 24 weeks
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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.
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Baseline, 12 weeks, 24 weeks
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Change from Baseline in the Eating Disorder Examination - Questionnaire (EDE-Q)
Délai: Baseline, 12, 24, 36, 48 weeks
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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.
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Baseline, 12, 24, 36, 48 weeks
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Change from Baseline in the Clinical Impairment Assessment (CIA)
Délai: Baseline, 12, 24, 36, 48 weeks
|
Measures the extent to which eating disorder symptoms impair functioning.
Higher scores indicate greater impairment.
|
Baseline, 12, 24, 36, 48 weeks
|
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Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10)
Délai: 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.
|
Baseline, 4, 8, 12, 24, 36, 48 weeks
|
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Change from Baseline in Daily Levels of Body Image Distress and Psychological Flexibility
Délai: Baseline, 8 Weeks
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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.
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Baseline, 8 Weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from Baseline in Heart Rate when Viewing Emotional Film Clips
Délai: Baseline, 8 weeks, 24 weeks
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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.
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Baseline, 8 weeks, 24 weeks
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Change from Baseline in Cognitive Flexibility - Set-Shifting as assessed by the Wisconsin Card Sort Test (WCST)
Délai: Baseline, 24 weeks
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68-item computerized version of the WCST using default settings; perseverative errors.
Decreases in errors indicates greater cognitive flexibility/adaptability.
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Baseline, 24 weeks
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Change from Baseline in Response Inhibition as assessed by Go/No-Go Task
Délai: Baseline, 8 weeks, 24 weeks
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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.
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Baseline, 8 weeks, 24 weeks
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from Baseline in the Body Dissatisfaction Subscale of the Eating Disorder Inventory-3
Délai: Baseline, 8 Weeks
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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.
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Baseline, 8 Weeks
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Change from Baseline in Problematic Social Media Use as assessed by the Bergen Social Media Addiction Scale
Délai: Baseline, 12 Weeks
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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.
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Baseline, 12 Weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 juin 2026
Achèvement primaire (Estimé)
15 juillet 2028
Achèvement de l'étude (Estimé)
31 juillet 2028
Dates d'inscription aux études
Première soumission
1 juin 2026
Première soumission répondant aux critères de contrôle qualité
1 juin 2026
Première publication (Réel)
8 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 août 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Pro00111571_1
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
IPD will be shared in the NIMH National Data Archive (NDA).
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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