A Randomized Controlled Trial Testing a Digital, Gamified Early Intervention for Eating Disorders ("FlexED")
26 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
128
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Rhonda M Merwin, Ph.D.
- Número de teléfono: 919-681-7231
- Correo electrónico: rhonda.merwin@duke.edu
Copia de seguridad de contactos de estudio
- Nombre: Dottie R Mayo
- Número de teléfono: 919-668-1935
- Correo electrónico: drm72@duke.edu
Ubicaciones de estudio
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705
- Reclutamiento
- Duke University
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Investigador principal:
- Rhonda M Merwin, Ph.D.
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Contacto:
- Dottie R Mayo
- Número de teléfono: 919-668-1935
- Correo electrónico: drm72@duke.edu
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: "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.
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|
Comparador activo: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Baseline, 8 weeks, 24 weeks
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Change from Baseline in Eye Gaze Fixations - Body-Image Related Images
Periodo de tiempo: 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
Periodo de tiempo: 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.
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8 weeks
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Change from Baseline in Eating Disorder Examination (EDE)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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Baseline, 12, 24, 36, 48 weeks
|
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Change from Baseline in the Clinical Impairment Assessment (CIA)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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.
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Baseline, 8 Weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline in Heart Rate when Viewing Emotional Film Clips
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline in the Body Dissatisfaction Subscale of the Eating Disorder Inventory-3
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de junio de 2026
Finalización primaria (Estimado)
15 de julio de 2028
Finalización del estudio (Estimado)
31 de julio de 2028
Fechas de registro del estudio
Enviado por primera vez
1 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de junio de 2026
Publicado por primera vez (Actual)
8 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
26 de agosto de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro00111571_1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
IPD will be shared in the NIMH National Data Archive (NDA).
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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