A Randomized Controlled Trial Testing a Digital, Gamified Early Intervention for Eating Disorders ("FlexED")
26 de agosto de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
128
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Rhonda M Merwin, Ph.D.
- Número de telefone: 919-681-7231
- E-mail: rhonda.merwin@duke.edu
Estude backup de contato
- Nome: Dottie R Mayo
- Número de telefone: 919-668-1935
- E-mail: drm72@duke.edu
Locais de estudo
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North Carolina
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Durham, North Carolina, Estados Unidos, 27705
- Recrutamento
- Duke University
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Investigador principal:
- Rhonda M Merwin, Ph.D.
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Contato:
- Dottie R Mayo
- Número de telefone: 919-668-1935
- E-mail: drm72@duke.edu
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline in the Body Image - Acceptance and Action Questionnaire (BI-AAQ)
Prazo: Baseline, 4, 8, 12, 24, 36, 48 weeks
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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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: Baseline, 12, 24, 36, 48 weeks
|
Measures the extent to which eating disorder symptoms impair functioning.
Higher scores indicate greater impairment.
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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)
Prazo: Baseline, 4, 8, 12, 24, 36, 48 weeks
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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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline in Heart Rate when Viewing Emotional Film Clips
Prazo: 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)
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline in the Body Dissatisfaction Subscale of the Eating Disorder Inventory-3
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
15 de junho de 2026
Conclusão Primária (Estimado)
15 de julho de 2028
Conclusão do estudo (Estimado)
31 de julho de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
1 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de junho de 2026
Primeira postagem (Real)
8 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
28 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de agosto de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Pro00111571_1
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
IPD will be shared in the NIMH National Data Archive (NDA).
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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