Programa de gerenciamento de estresse
Correlatos fisiológicos da redução do estresse não farmacológico
This study will test the immediate and long term (post 4 weeks of daily practice) effectiveness of two breathwork practices, cyclic sighing and box breathing, in comparison to hypnosis and an audiobook about stress, on psychological and physiological variables.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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Stanford, California, Estados Unidos, 94305
- Psychiatry & Behavioral Sciences
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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:
- Age 18 or older
- No contraindications to MRI imaging (like ferromagnetic metal in their body)
Exclusion Criteria:
- Pregnant or planning to get pregnant during study participation.
- Not able or willing to come to research location twice for MRI assessments
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 |
|---|---|
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Experimental: Cyclic Sighing Breathing
Ten minutes a day of active breathwork practice for 28 days delivered remotely through a video link. Participants will also practice 10 minutes of active breathwork during the 2 MRI assessments, one before the start of the 28 days, and one after the completion of the 28 days. |
Participants are instructed to be seated or lying down, and can keep their eyes open or closed throughout the 10 minutes of the breathing practice during the 28 days. Participants are instructed to keep their eyes closed when practicing the 10 minutes of the cyclic sighing during the 2 MRI assessments. The cyclic sighing protocol consists of a breathing pattern that involves inhaling deeply, starting abdominally, inhaling through the nose until lungs feel comfortably filled, immediately followed by a second shorter inhale, also through the nose, to maximally inflate the lungs. Then participants are instructed to slowly exhale through the mouth until their lungs feel empty. This cycle is repeated for 10 minutes. |
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Experimental: Box Breathing
Ten minutes a day of active breathwork practice for 28 days delivered remotely through a video link. Participants will also practice 10 minutes of active breathwork during the 2 MRI assessments, one before the start of the 28 days, and one after the completion of the 28 days. |
Participants are instructed to be seated or lying down, and can keep their eyes open or closed throughout the 10 minutes of the breathing during the 28 days. Participants are instructed to keep their eyes closed when practicing the 10 minutes of the box breathing during the 2 MRI assessments. The CO2 tolerance test is done at baseline to determine their comfort level with the duration of each side of the box during box breathing. The box breathing protocol consists of a four-part breathing technique. The practice involves breathing through the nose in four equally timed parts: inhale, hold, exhale, and hold again, forming a 'box' of breaths (e.g. 4 sec inhale, 4 sec hold, 4 sec exhale, 4 sec hold).This cycle is repeated for 10 minutes. |
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Experimental: Hypnosis
Ten minutes a day of hypnosis practice for 28 days delivered remotely through an audio link. Participants will also practice 10 minutes of hypnosis during the 2 MRI assessments, one before the start of the 28 days, and one after the completion of the 28 days |
Participants are instructed to sit comfortably or lie down during the 28 day at home practice (Participants will be lying down in the scanner during the 2 MRIs). Then participants are asked to look up, slowly close their eyes, take a deep breath, slowly exhale, and let their body float, and then to imagine floating in a bath, a lake, a hot tub, or floating in space. Participants are then asked to picture an imaginary screen and visualize a place where it would naturally feel comfortable and relaxed. The participants then divide the screen in half and picture on the left side one thing that is causing them stress, with the rule that no matter what the participant picture, to keep their body comfortable and relaxed. Then on the right side of the screen the participants are asked to picture one thing that can be done about the problem on the left. At the end the participant will be guided to come out of the state of hypnosis. This exercise will take 10 minutes. |
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Comparador Ativo: Audiobook on Stress
Ten minutes a day of listening to sections of an audiobook about stress for 28 days (passive listening) delivered remotely through an audio link. Participants will also listen to the 10 minute segments during the 2 MRI assessments, one before the start of the 28 days, and one after the completion of the 28 days. |
Participants are instructed to be seated or lying down, and can keep eyes open or closed throughout the 10 minutes of listening to the audiobook during the 28 days. Participants are instructed to keep their eyes closed during the 2 MRI assessments. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Neural Activation
Prazo: Baseline Scan (Day 0) and and Follow-up Scan (From day 29 up to 4 weeks later, depending on the Scan scheduling availability)
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As measured for example by Fractional amplitude of low-frequency fluctuation (fALFF) signal, assessed using functional Magnetic Resonance Imaging (fMRI). |
Baseline Scan (Day 0) and and Follow-up Scan (From day 29 up to 4 weeks later, depending on the Scan scheduling availability)
|
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State Anxiety scale score
Prazo: Immediate: Baseline Scan (Day 0) and Follow-up Scan (from day 29 up to 4 weeks later, depending on the Scan scheduling availability); Daily: from Baseline (Day 0) to a day prior to Endpoint (Day 28)
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The State-Trait Anxiety Inventory (STAI) is an instrument for measuring anxiety in adults. It has 2 scales: State Anxiety (S-Anxiety) and Trait Anxiety (T-Anxiety). The S-Anxiety scale measures anxiety due to temporary conditions, and the T-Anxiety measures anxiety on a general or more long-standing scale. The S-Anxiety is a 20-item scale; each item yields a score of 1 to 4. Scores on the STAI S-Anxiety scale increase in response to physical danger and psychological stress and decrease as a result of relaxation training. |
Immediate: Baseline Scan (Day 0) and Follow-up Scan (from day 29 up to 4 weeks later, depending on the Scan scheduling availability); Daily: from Baseline (Day 0) to a day prior to Endpoint (Day 28)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Respiratory Rate
Prazo: Daily from Baseline (Day 0) to a day prior to Endpoint (Day 28)
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Daily respiratory rate (RR) will be collected by WHOOP Strap 2.0, a wearable photoplethysmography (PPG) wrist sensor. |
Daily from Baseline (Day 0) to a day prior to Endpoint (Day 28)
|
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Heart Rate Variability
Prazo: Immediate: Baseline Scan (Day 0) and Follow-up Scan (From day 29 up to 4 weeks later, depending on the Scan scheduling availability); Daily: from Baseline (Day 0) to a day prior to Endpoint (Day 28)
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Heart rate variability (HRV) will be measured in two modalities. Immediate continuous HRV, collected during resting-state MRI scans, will be measured by a wearable photoplethysmography (PPG) finger sensor. Daily HRV over the 28-day training period (RMSSD) will be collected by WHOOP Strap 2.0, a wearable PPG wrist sensor. |
Immediate: Baseline Scan (Day 0) and Follow-up Scan (From day 29 up to 4 weeks later, depending on the Scan scheduling availability); Daily: from Baseline (Day 0) to a day prior to Endpoint (Day 28)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David Spiegel, MD, Stanford University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
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
- 72131
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