Health Enhancement And Resilience Training (HEART)
22 de janeiro de 2021 atualizado por: University of California, San Francisco
The Effect of a Stress Reduction Program Using Mindfulness Techniques on Markers of Cellular Stress and Aging
The purpose of this research study is to examine whether a stress reduction intervention can improve health, mood and biological markers of cellular stress and aging in a group of chronically-stressed maternal caregivers and healthy maternal controls.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
This stress-reduction intervention was added into an ongoing observational study in May of 2013. The parent study is a prospective cohort study of the effects of chronic stress in a group of maternal caregivers with children on the autism spectrum and healthy controls whose children have no diagnosis. Study participants are being invited to enroll in a 12-week stress reduction course based on the principles of mindfulness. They will attend four six-hour workshops and participate in 12 weekly hour-long web video conferencing calls to reinforce what is taught in the workshops.
At the beginning and the end of the intervention, they complete self-report measures of psychological well-being and give saliva samples. Since the women are also participating in the longitudinal study, we have other before and after data for them. These include psycho-social measures, body measurements, psycho-physiology measurements, cognitive tests, actigraphy (for sleep), as well as saliva (for hormones), hair (for hormones) and blood (for telomeres, telomerase, gene expression, circulating hormones, inflammation and oxidative stress).
Tipo de estudo
Intervencional
Inscrição (Real)
70
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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California
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San Francisco, California, Estados Unidos, 94118
- University of California, San Francisco
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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
20 anos a 50 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- Must have at least one child between 2 and 16 at time of enrollment
- Caregivers must have a child diagnosed in that age range diagnosed with an autism spectrum disorder.
- Controls must have a healthy child in that age range. All women must be
Exclusion Criteria:
- Chronic disease, including recent history of cancer
- History of psychiatric disorder, such as bipolar disorder or post-traumatic stress disorder
- Medications, including statins, anti-anxiety drugs, and for controls only anti-depressants.
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: Ciência básica
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Stress-reduction class
Study participants enrolled in a 12-week stress reduction course based on the principles of mindfulness.
They attended four six-hour workshops and participated in 12 weekly hour-long web video conferencing calls to reinforce what was taught in the workshops.
We have two groups: chronically-stressed maternal caregivers of children on the autism spectrum and control mothers whose children have no significant psychiatric or physical impairment.
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Study participants enrolled in a 12-week stress reduction course based on the principles of mindfulness.
They attended four six-hour workshops and participated in 12 weekly hour-long web video conferencing calls to reinforce what was taught in the workshops.
We have two groups: chronically-stressed maternal caregivers of children on the autism spectrum and control mothers whose children have no significant psychiatric or physical impairment.
Both groups received similar instruction.
Outros nomes:
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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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Salivary telomere length
Prazo: Change from beginning to end of 12-week intervention
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Participants will give saliva samples at the beginning and the end of the intervention.
Salivary telomere length will be analyzed at both time points.
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Change from beginning to end of 12-week intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Psychological Well-Being
Prazo: Change from beginning to end of 12-week intervention
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We will collect perceived stress, acceptance and awareness of emotions and rumination at the beginning and at the end of the intervention.
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Change from beginning to end of 12-week intervention
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Telomere length from blood cells
Prazo: Change over six months pre- and post-intervention
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Since participants are also taking part in an ongoing non-interventional longitudinal study, they will provide blood samples at their 18-month study visit, which occurs before the start of the intervention, and at the 24-month study visit, which occurs after the end of the intervention.
We will measure telomere length pre- and post-intervention in a variety of blood cell types.
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Change over six months pre- and post-intervention
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Telomerase
Prazo: Change over 6 months pre- and post-intervention
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Since participants are also taking part in an ongoing non-interventional longitudinal study, they will provide blood samples at their 18-month study visit, which occurs before the start of the intervention, and at the 24-month study visit, which occurs after the end of the intervention.
We will measure telomerase pre- and post-intervention in a variety of blood cell types.
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Change over 6 months pre- and post-intervention
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Cognitive functioning
Prazo: Change over six months pre- and post-intervention
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Since participants are also taking part in an ongoing non-interventional longitudinal study, they will complete a battery of cognitive tasks at their 18-month study visit, which occurs before the start of the intervention, and at the 24-month study visit, which occurs after the end of the intervention.
We will be able to assess performance pre- and post-intervention, to see if it improves after the stress-reduction training.
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Change over six months pre- and post-intervention
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Elissa S Epel, PhD, University of California, San Francisco
- Investigador principal: Elizabeth Blackburn, PhD, University of California, San Francisco
- Investigador principal: Jue Lin, PhD, University of California, San Francisco
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)
1 de maio de 2013
Conclusão Primária (Real)
1 de novembro de 2015
Conclusão do estudo (Real)
1 de novembro de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
10 de julho de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de outubro de 2013
Primeira postagem (Estimativa)
9 de outubro de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
26 de janeiro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de janeiro de 2021
Última verificação
1 de janeiro de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 10-02063
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