- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07789314
Just-in-Time Coping Prompts for Reactive Digital Behavior in College Students (REACT)
24 de agosto de 2026 atualizado por: University of Florida
REACT: A Just-in-Time Adaptive Intervention to Reduce Reactive Digital Behavior in College Students
This study looks at the moments when college students feel a strong emotional swing, and how those moments relate to reacting online when upset, drinking alcohol, and eating in response to emotions.
Participants wear a wrist device and answer brief check-ins on their phone several times a day for about five weeks.
During part of that time, a study app sometimes sends a short coping message at moments when the wrist device and check-ins suggest emotions are shifting quickly.
Whether a message is sent at any given moment is decided at random, and the study compares what participants do in the short window afterward.
The study is a pilot designed to test whether the approach is feasible and to estimate how large its effects are.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
REACT is a five-week micro-randomized trial in University of Florida students age 18 and older.
Participants complete a baseline battery, wear a Garmin Venu 3, and respond to five to six smartphone check-ins per day.
Week one is a no-prompt run-in that establishes each participant's own baseline distribution of momentary affective variability, indexed by the mean square of successive differences on consecutive affect ratings.
From week two through week five, the app evaluates up to six decision points per day.
A decision point is flagged when the participant's current variability exceeds their own 80th percentile threshold, computed within person rather than against a group average.
At each available decision point the app randomizes with probability 0.5 whether to deliver a brief coping message, and if so selects a message type from those eligible in that context.
Availability rules exclude sleep, stale device data, a 60-minute cooldown, a daily cap, and any safety override.
Proximal outcomes are drawn from the first check-in within two hours after the decision point.
Analysis uses weighted and centered least squares to estimate causal excursion effects, with pre-specified moderators.
Tipo de estudo
Intervencional
Inscrição (Estimado)
80
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: Yonghwan Chang, PhD
- Número de telefone: 352-294-1664
- E-mail: yhchang@ufl.edu
Locais de estudo
-
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Florida
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Gainesville, Florida, Estados Unidos, 32611
- University of Florida
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Contato:
- Yonghwan Chang, PhD
- Número de telefone: 352-294-1664
- E-mail: yhchang@ufl.edu
-
Investigador principal:
- Yonghwan Chang, PhD
-
-
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
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- Currently enrolled University of Florida student
- Age 18 years or older
- Owns a smartphone used daily
- Willing to wear a wrist-worn device and complete brief check-ins several times daily for approximately five weeks
Exclusion Criteria:
- Varsity student-athlete governed by the university athletic association
- Unable to complete study procedures in English
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: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Coping prompt delivered
Decision points at which the randomization outcome is to deliver a brief cognitive-behavioral or acceptance-based coping message.
Message type is selected at random from those eligible in the participant's current context.
Every participant contributes decision points to this condition.
|
A single short message of one to three sentences delivered to the participant's smartphone at a randomized decision point, taking roughly fifteen to thirty seconds to read.
Messages apply cognitive-behavioral techniques including thought records, perspective-taking, decatastrophizing, cost-benefit checks, implementation intentions, and behavioral redirection, or acceptance-based techniques including cognitive defusion, acceptance, values anchoring, urge surfing, and present-moment grounding.
Delivery is capped at four messages per day with a minimum sixty-minute interval and is confined to participant-set waking hours.
Messages may be dismissed without responding.
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|
Comparador Ativo: No coping prompt or active control message
Decision points at which the randomization outcome is not to deliver a coping message.
A brief neutral, non-directive acknowledgment message may be delivered as an active control so that receiving any message can be separated from receiving a coping message.
Every participant contributes decision points to this condition.
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A brief neutral acknowledgment message matched to the coping messages on delivery mechanism and approximate length, containing no coping technique or behavioral suggestion.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Momentary urge to post or reply reactively, score on a 7-point scale.
Prazo: Within 2 hours after each randomized decision point, across weeks 2 to 5.
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Self-reported urge to post or reply about something upsetting, rated 1 to 7 at the first check-in within two hours after a randomized decision point.
Higher scores indicate greater urge.
Analyzed as a causal excursion effect comparing decision points at which a coping message was delivered with those at which it was not.
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Within 2 hours after each randomized decision point, across weeks 2 to 5.
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Momentary urge to drink alcohol, score on a 7-point scale.
Prazo: Within 2 hours after each randomized decision point, across weeks 2 to 5.
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Self-reported current urge to drink alcohol, rated 1 to 7 at the first check-in within two hours after a randomized decision point.
Higher scores indicate greater urge.
Analyzed as a causal excursion effect.
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Within 2 hours after each randomized decision point, across weeks 2 to 5.
|
|
Momentary emotional influence on eating, score on a 7-point scale.
Prazo: Within 2 hours after each randomized decision point, across weeks 2 to 5.
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Self-reported rating of how much emotions influenced eating since the previous check-in, rated 1 to 7 at the first check-in within two hours after a randomized decision point.
Analyzed as a causal excursion effect.
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Within 2 hours after each randomized decision point, across weeks 2 to 5.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of delivered prompts receiving a response
Prazo: Through study completion, approximately 5 weeks per participant.
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Number of prompts receiving a rating response divided by number of prompts delivered.
Pre-registered benchmark is 60 percent.
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Through study completion, approximately 5 weeks per participant.
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Proportion of enrolled participants retained to study end.
Prazo: Through study completion, approximately 5 weeks per participant.
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Number of participants completing the study divided by number enrolled.
Pre-registered benchmark is 85 percent.
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Through study completion, approximately 5 weeks per participant.
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Momentary reactive online behavior since the previous check-in, self-reported occurrence
Prazo: Within 2 hours after each randomized decision point, across weeks 2 to 5.
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Self-reported occurrence of posting or replying while upset since the previous check-in, reported yes or no at the first check-in within two hours after a randomized decision point.
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Within 2 hours after each randomized decision point, across weeks 2 to 5.
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Number of standard drinks consumed since the previous check-in, self-reported count
Prazo: Within 2 hours after each randomized decision point, across weeks 2 to 5.
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Self-reported number of standard drinks consumed since the previous check-in.
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Within 2 hours after each randomized decision point, across weeks 2 to 5.
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Loss-of-control eating rating, score on a 7-point scale
Prazo: Within 2 hours after each randomized decision point, across weeks 2 to 5
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Self-reported sense of losing control while eating since the previous check-in, rated 1 to 7.
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Within 2 hours after each randomized decision point, across weeks 2 to 5
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Proportion of scheduled check-ins completed
Prazo: Through study completion, approximately 5 weeks per participant.
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Number of completed check-ins divided by number of scheduled check-ins.
Pre-registered feasibility benchmark is 75 percent.
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Through study completion, approximately 5 weeks per participant.
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Proportion of waking hours with valid wearable data
Prazo: Through study completion, approximately 5 weeks per participant.
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Hours of valid physiological data divided by estimated waking hours.
Pre-registered benchmark is 80 percent.
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Through study completion, approximately 5 weeks per participant.
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Prompt helpfulness rating, score on a 7-point scale
Prazo: Week 3 and end of study, approximately week 5.
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Participant rating of how helpful the coping prompts were, rated 1 to 7.
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Week 3 and end of study, approximately week 5.
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System Usability Scale total score.
Prazo: End of study, approximately week 5.
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System Usability Scale (Brooke, 1996) total score, range 0 to 100, higher scores indicating better usability.
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End of study, approximately week 5.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Yonghwan Chang, PhD, University of Florida
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 (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
1 de maio de 2027
Conclusão do estudo (Estimado)
1 de agosto de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
23 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de agosto de 2026
Primeira postagem (Real)
27 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB202600940
- 00135244 (Número de outro subsídio/financiamento: University of Florida Research Opportunity Seed Fund)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual participant data will not be shared outside the research team.
This is a pilot study collecting sensitive behavioral and biological data from a small identifiable campus population, and the informed consent does not provide for external sharing of individual-level data.
Aggregate results will be published.
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
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 .