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- Ensaio Clínico NCT01721499
Decreasing Stress and Improving Self-control With "Stress in Control" (Sync) Training (Sync)
This is a study of treatment approaches aimed to improve self-control and decrease stress and unhealthy/maladaptive behaviors such as drinking, overeating, and smoking.
High levels of stress may make it harder to maintain self-control, especially when trying to control our unhealthy behaviors. Training on improving self control and decreasing stress may help decrease unhealthy behaviors. The goal of this new training program will be to decrease a subject's unhealthy behavior by helping them better manage their stress and improve their self control over unhealthy habits.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study proposes to pilot a mindfulness based affect-regulation treatment approach to improve self-control and physiological and biochemical indicators of stress, as well as decrease unhealthy/maladaptive behaviors such as drinking, overeating, and smoking. The broad aims of the treatment approach will be to teach participants to (1) observe and increase awareness of cognitive, affective, bodily sensations/expressions and action-urge components of emotional/compulsion experiences; and (2) develop alternate affective, behavioral and cognitive coping strategies in managing and regulating affect/urge experiences. It is hoped that the findings from this study will aid in the further development of treatment and prevention programs targeting stress reduction and coping to improve control over maladaptive behaviors and decrease physical and mental health symptoms.
Aims:
- Develop a mindfulness based affect-regulation therapy manual, and training materials to train therapists on a treatment approach aimed at improving self-control over unhealthy addictive behaviors.
- Develop and implement "Stress in Control" (SynC) training competence and adherence rating scales;
- Conduct a preliminary study using the SynC manual, which will evaluate the effectiveness and feasibility of SynC in comparison to a Primary Care Treatment Control Group and a Historical Control Group approach for 100 individuals interested in help in decreasing targeted unhealthy behaviors. Primary outcomes will be a reduction in unhealthy problem behaviors, and secondary outcomes will be decrease in measures of stress, and increases in emotion regulation and self control.
- (secondary aim) Collect baseline data on measures of self control, mood, coping, personality, cognitive functioning, acute and chronic stress, and mental and physical health on a large sample of subjects seeking help in decreasing unhealthy behaviors.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06519
- Yale University
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Between ages 18-60 years;
- Able to read and write;
- Interested in treatment aimed at gaining greater control over an unhealthy, maladaptive behavior
Exclusion Criteria:
- Any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation
- Pregnant women will be excluded.
- Inability to give informed consent
- Traumatic brain injury or loss of consciousness
- Medical problems requiring immediate attention
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Mindfulness intervention
The mindfulness intervention consists of weekly group format mindfulness instruction and skills development, weekly individual therapy sessions, and 6 nutritional sessions. The control group receives 6 nutritional sessions only. |
weekly group and individual skills training to improve self control and decrease stress.
|
Comparador Ativo: Nutrition Control Group
The control group receives 6 nutritional counseling sessions.
|
weekly group and individual skills training to improve self control and decrease stress.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Development of treatment approaches
Prazo: 1 year
|
Develop a mindfulness based affect-regulation therapy manual, and training materials to train therapists on a treatment approach aimed at improving self-control over unhealthy addictive behaviors.
|
1 year
|
Measure effectiveness of intervention
Prazo: 2 years
|
Conduct a preliminary study using the SynC manual, which will evaluate the effectiveness and feasibility of SynC in comparison to a Primary Care Treatment
|
2 years
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
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
- 0809004271
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 .
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