FlexED: uma intervenção precoce digital e gamificada para transtornos alimentares
The goal of this clinical trial is to test a new intervention for body-image distress to reduce eating disorder symptoms in young women and girls between the ages of 15-25 years old.
Participants complete up to 8 digital sessions using their mobile phone that include a character, story line and interactive exercises, games and digital rewards. Everyone in the study completes the intervention after different periods of time (2, 4 or 6 weeks) of completing assessments.
Researchers will examine the impact of the intervention on participants ability to respond flexibly to body-image distress or triggers, measuring things like heart rate, eye gaze, and reaction time to body-image related words and images, and test how long it takes to see change.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This multiple baseline experiment tests the impact of a digital, gamified early intervention for eating disorders on body-image psychological flexibility and assesses treatment dose. Twenty-four young women and girls with eating disorder (ED) symptoms are randomized to baseline duration between 2-6 weeks. Participants complete up to eight 20-30 minute sessions of a multimedia application using their mobile phone. Psychological flexibility is measured repeatedly using a multi-level, multi-dimensional assessment strategy of self-report and lab-based tasks assessing flexibility in cognition, affect and attention with body-image related stimuli during the baseline and treatment phases to estimate treatment effects.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
North Carolina
-
Durham, North Carolina, Estados Unidos, 27705
- Duke University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Female identified 15-25 years old
- Weight Concerns Scale score of >47
- Eating disorder behaviors with onset at current level <3 years
Exclusion Criteria:
- Currently meet diagnostic criteria for anorexia or bulimia nervosa
- Psychosis, substance use disorder or current suicidal ideation or self-harm.
- Start or change in psychiatric medications within the past month.
- NonEnglish Speaking.
- Presents with other specified feeding or eating disorder (OSFED) that does not includes weight/shape concerns as a primary feature (e.g., Avoidant Restrictive Food Intake Disorder).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 2-Week Baseline Duration
2 weeks of assessment, then 8 weeks of intervention |
Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises. |
|
Experimental: 4-Week Baseline Duration
4 weeks of assessment, then 8 weeks of intervention |
Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises. |
|
Experimental: 6-Week Baseline Duration
6 weeks of assessment, then 8 weeks of intervention |
Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises. |
|
Experimental: Condensed schedule
2 weeks of assessment, then 4 weeks of intervention (sessions twice a week) |
Intervention consists of eight 20-30 minute sessions of a digital intervention based on Acceptance and Commitment Therapy (ACT). Participants learn skills of body image flexibility by following an avatar through a story line and completing interactive exercises. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Body Image - Acceptance and Action Questionnaire-5 (BI-AAQ-5)
Prazo: Baseline, 6-8 weeks and 12 weeks
|
5-item measure assessing the ability to behave flexibly in the presence of negative thoughts and feelings about the body. Scores range from 5 to 35 with higher scores indicating greater flexibility. |
Baseline, 6-8 weeks and 12 weeks
|
|
High Frequency Heart Rate Variability (HF-HRV)
Prazo: Baseline, 6-8 weeks, and 12 weeks
|
Heart rate variability during provocation of body image distress; greater variability indicates an increased capacity to modulate arousal and distress. Indexed by HF Power ms^2 (Induction-Rest). |
Baseline, 6-8 weeks, and 12 weeks
|
|
Change From Baseline in Biased Processing of Body Image Stimuli Relative to Neutral Stimuli
Prazo: Baseline, 6-8 weeks, and 12 weeks
|
Biased processing of stimuli is assessed using an emotional Stroop task with body image and neutral stimuli. Improvements are indicated by decreases in bias score (decreases in difference in reaction time between evocative and neutral stimuli). |
Baseline, 6-8 weeks, and 12 weeks
|
|
CompACT-10 (Comprehensive Assessment of Acceptance and Commitment Therapy)
Prazo: Baseline, 6-8 weeks, 12 weeks
|
10-item measure assessing psychological flexibility. Total scores range from 10 to 70 with higher scores indicating greater flexibility. |
Baseline, 6-8 weeks, 12 weeks
|
|
Number of Eye Gaze Fixations on Pathology-relevant, Body-image Stimuli
Prazo: Baseline, 6-8 weeks, 12 weeks
|
Number of fixations on body and food related images presented during HF-HRV task. |
Baseline, 6-8 weeks, 12 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Pro00111571
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .