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A Study Testing a Digital, Gamified Early Intervention for Eating Disorders ("FlexED")

1 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

128

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • North Carolina
      • Durham, North Carolina, Stati Uniti, 27705
        • Duke University
        • Investigatore principale:
          • Rhonda M Merwin, Ph.D.
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: "FlexED"
Seven 20-minute sessions of an online, multimedia application that teaches psychological flexibility with body-image related thoughts and feelings.
Comportamentale: FlexED
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.
Comparatore attivo: Educational Control
Seven 20-minute online education sessions about eating disorders.
Comportamentale: Educational Control
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)
Lasso di tempo: 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.
Baseline, 4, 8, 12, 24, 36, 48 weeks
Change from Baseline in the Body-Image Stroop Bias Score
Lasso di tempo: 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.
Baseline, 8 weeks, 24 weeks
Change from Baseline in Eye Gaze Fixations - Body-Image Related Images
Lasso di tempo: 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.
Baseline, 8 weeks, 24 weeks
Acceptability of the intervention
Lasso di tempo: 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.
8 weeks
Change from Baseline in Eating Disorder Examination (EDE)
Lasso di tempo: 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.
Baseline, 12 weeks, 24 weeks
Change from Baseline in the Eating Disorder Examination - Questionnaire (EDE-Q)
Lasso di tempo: 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.
Baseline, 12, 24, 36, 48 weeks
Change from Baseline in the Clinical Impairment Assessment (CIA)
Lasso di tempo: 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
Change from Baseline in the Comprehensive Assessment of Acceptance and Commitment Therapy Processes -10 (CompACT-10)
Lasso di tempo: 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
Change from Baseline in Daily Levels of Body Image Distress and Psychological Flexibility
Lasso di tempo: 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.
Baseline, 8 Weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Heart Rate when Viewing Emotional Film Clips
Lasso di tempo: 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.
Baseline, 8 weeks, 24 weeks
Change from Baseline in Cognitive Flexibility - Set-Shifting as assessed by the Wisconsin Card Sort Test (WCST)
Lasso di tempo: Baseline, 24 weeks
68-item computerized version of the WCST using default settings; perseverative errors. Decreases in errors indicates greater cognitive flexibility/adaptability.
Baseline, 24 weeks
Change from Baseline in Response Inhibition as assessed by Go/No-Go Task
Lasso di tempo: 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.
Baseline, 8 weeks, 24 weeks

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in the Body Dissatisfaction Subscale of the Eating Disorder Inventory-3
Lasso di tempo: 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.
Baseline, 8 Weeks
Change from Baseline in Problematic Social Media Use as assessed by the Bergen Social Media Addiction Scale
Lasso di tempo: 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.
Baseline, 12 Weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Duke University

Collaboratori

National Institute of Mental Health (NIMH)

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

15 luglio 2028

Completamento dello studio (Stimato)

31 luglio 2028

Date di iscrizione allo studio

Primo inviato

1 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2026

Primo Inserito (Effettivo)

8 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Pro00111571_1

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

IPD will be shared in the NIMH National Data Archive (NDA).

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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