Saúde Mental do Adolescente Aprimorada pela Tecnologia (TEAM) (TEAM)
13 de agosto de 2025 atualizado por: University of Notre Dame
Aproveitando biomarcadores e novas tecnologias para reduzir o risco de automutilação e abuso de substâncias entre adolescentes altamente vulneráveis
A automutilação não suicida na adolescência (NSSI) e o uso indevido de álcool, sozinhos e especialmente em combinação, pressagiam prejuízo funcional significativo na idade adulta (por exemplo, disfunção de relacionamento, depressão, tendências suicidas).
Embora as intervenções psicossociais para NSSI e uso de substâncias sejam eficazes para alguns, elas também são caras e requerem médicos altamente treinados.
Portanto, o tratamento muitas vezes não está disponível para adolescentes desfavorecidos e para aqueles que vivem em áreas rurais.
Assim, tratamentos alternativos de menor custo são necessários.
Avaliaremos a eficácia da estimulação transcutânea não invasiva do nervo vago (tVNS), um tratamento eficaz para a depressão, na redução do risco de NSSI e uso indevido de substâncias entre adolescentes vulneráveis.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
Os objetivos gerais do projeto proposto são três. OBJETIVO 1: Avaliar a eficácia clínica da tVNS na redução da NSSI e do uso indevido de álcool entre adolescentes vulneráveis. Nossa hipótese é que tVNS auto-administrado, entregue em sessões de 25 minutos, reduzirá o auto-relato de NSSI e o uso de álcool, melhorará a regulação emocional auto-relatada pelos adolescentes e produzirá melhorias nos marcadores do sistema nervoso simpático e parassimpático de regulação emocional e vulnerabilidade a NSSI e abuso de álcool. OBJETIVO 2: Avaliar a adesão ao tratamento em comparação com intervenções psicossociais tradicionais de duração similar. Nossa hipótese é que os adolescentes demonstrarão maior adesão ao tratamento do que o observado em intervenções psicossociais tradicionais de duração semelhante e classificarão o tVNS como aceitável, discreto e favorável ao tratamento face a face. OBJETIVO 3: Avaliar os efeitos dos maus-tratos na tVNS. Nossa hipótese é que o tVNS será eficaz para aqueles com histórico de maus-tratos.
Embora raramente usado entre adolescentes, o tVNS altera as respostas neurais e emocionais a estímulos tristes e, entre adultos, reduz o risco de suicídio até cinco anos depois. No momento, está sendo avaliado como um tratamento para abuso de álcool em um ensaio clínico financiado pelo NIH. Isso sugere potencial para tratar NSSI, abuso de álcool, sintomas de estresse pós-traumático (PTSS) e outros distúrbios de desregulação emocional. Conforme descrito acima, testaremos a eficácia da tVNS em alterar o risco comportamental, emocional e do sistema nervoso autônomo para NSSI e uso indevido de álcool, avaliaremos a adesão e aceitabilidade da tVNS entre adolescentes e determinaremos se as histórias de maus-tratos moderam a resposta ao tratamento.
Tipo de estudo
Intervencional
Inscrição (Real)
30
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.
Locais de estudo
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Indiana
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South Bend, Indiana, Estados Unidos, 46617
- University of Notre Dame
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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
13 anos a 17 anos (Filho)
Aceita Voluntários Saudáveis
Sim
Descrição
Critério de inclusão:
- Já usou álcool
- Envolveu-se em ≥ 3 episódios de NSSI nos últimos 6 meses ou ≥ 5 na vida (1 destes 5 deve ser no último ano)
- Possuir um smartphone (iPhone ou Android)
Critério de exclusão:
- Autismo
- Esquizofrenia
- Possui marca-passo cardíaco, desfibrilador implantado ou dispositivo eletrônico implantado ou metálico
- Grávida ou amamentando
- Tem um histórico de convulsões ou epilepsia
- Distúrbio da Articulação Temperomandibular
- Paralisia de Bell
- Função prejudicada dos nervos cranianos ou dor facial
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: Grupo de tratamento
Os participantes receberão um dispositivo tVNS.
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Os participantes participarão de sessões tVNS de 25 minutos todos os dias durante 30 dias.
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Experimental: Grupo sem tratamento
Os participantes não receberão um dispositivo tVNS.
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Os participantes não receberão nenhuma intervenção.
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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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Mudança da linha de base em comportamentos de autolesão não suicida e uso indevido de álcool no dia 30
Prazo: 30 dias
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Os participantes participarão de sessões tVNS de 25 minutos diariamente.
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30 dias
|
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Manutenção dos efeitos do tratamento 3 meses após a intervenção
Prazo: 3 meses
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Os participantes serão avaliados quanto à manutenção de tais efeitos de tratamento 3 meses após a intervenção.
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3 meses
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Mudança da linha de base na regulação emocional no dia 30
Prazo: 30 dias
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Os participantes completarão uma pesquisa de 2 a 3 minutos diariamente, na qual deverão relatar diferentes sentimentos e emoções, como felicidade, tristeza e raiva.
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30 dias
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Adesão à intervenção tVNS desde a linha de base até o dia 30
Prazo: 30 dias
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A adesão às sessões tVNS diárias auto-administradas de 25 minutos dos participantes será medida a partir do aplicativo de telefone tVNS dos participantes.
Eles também relatarão a aceitabilidade, intromissão e favorabilidade do tVNS.
|
30 dias
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Theodore P Beauchaine, PhD, University of Notre Dame
- Investigador principal: Brooke A Ammerman, PhD, University of Notre Dame
- Investigador principal: Kristin Valentino, PhD, University of Notre Dame
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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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)
6 de setembro de 2022
Conclusão Primária (Real)
15 de janeiro de 2025
Conclusão do estudo (Real)
15 de janeiro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
11 de abril de 2022
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de abril de 2022
Primeira postagem (Real)
25 de abril de 2022
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de agosto de 2025
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de agosto de 2025
Última verificação
1 de agosto de 2025
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 21-11-6898
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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
produto fabricado e exportado dos EUA
Não
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