Evaluation of a Yoga Intervention for Post-Traumatic Stress Disorder (EYIPTSD)
19 de março de 2013 atualizado por: Sat Bir Khalsa, PhD, Brigham and Women's Hospital
The main objective of this preliminary randomized controlled clinical trial is to establish efficacy and feasibility of a yoga-based treatment for PTSD in military veterans as compared to a delayed yoga treatment (waitlist control) group.
Secondary objectives are to evaluate PTSD characteristics that may also be improved with the treatment and acceptability and compliance with the treatment.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Specific Aims:
- To evaluate the hypothesis that a 10-week yoga-based intervention will reduce PTSD severity to a statistically and clinically significant degree relative to a pretreatment baseline evaluation and to a waitlist control group.
- To evaluate the hypothesis that PTSD patients will show improvement in regulation of physiological arousal in the autonomic nervous system relative to pretreatment.
- To evaluate that hypothesis that symptoms associated with PTSD such as depression, anxiety, insomnia and quality of life will also be improved.
- To evaluate the hypothesis that military veterans with PTSD can be successfully recruited into a yoga intervention study and will find the intervention acceptable and tolerable and will exhibit high compliance.
Tipo de estudo
Intervencional
Inscrição (Real)
108
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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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Brigham and Women's Hospital
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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
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Male and female military veterans and active duty military personnel aged 18 and older
- A DSM IV diagnosis of post-traumatic stress disorder
- Potential subjects on medications are eligible to participate in the study
- Potential subjects who receive ongoing medical or psychological treatment are eligible to participate in this study as long as these treatments do not include more than one hour weekly of relaxation and mind-body based stress reduction strategies (strategies directly related to meditation and yoga)
- Potential subjects are eligible to participate in this study if they have sufficient mental and physical ability to fully participate in the parameters of the study. Subjects must be able to understand and comply with instructions in the group yoga sessions and home practice, complete questionnaires, participate in clinical interviews, and take part in all data collection activities. Subjects with severe mental or physical concerns that may prevent them from understanding and/or complying with the treatment will be excluded. For example, potential subjects confined to wheelchairs will not be eligible, although subjects with artificial limbs who are able to reasonably participate in the intervention may be deemed eligible. These determinations will be made during discussions with potential subjects on a case by case basis during the screening process
Exclusion Criteria:
- Potential subjects are ineligible if pregnant and in their third trimester.
- Potential subjects are ineligible if they are confined to a wheel chair.
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Tratamento de ioga
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The 10-week Kripalu-style yoga treatment will consist of 20 biweekly 90-minute group training/practice sessions.
In addition, subjects will also receive CD's and written instructions for the daily 15-minute sessions, which they will use to guide them through the yoga procedures to be done at home.
Outros nomes:
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Sem intervenção: Waitlist
Waitlist control, no active treatment, treatment as usual, active treatment offered after waitlist control period.
This study began as a single arm treatment trial and then transitioned to a randomized controlled trial.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Clinician Administered PTSD Scale (CAPS)
Prazo: pre-intervention and 10 weeks
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pre-intervention and 10 weeks
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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PTSD Checklist Military Version (PCL-M)
Prazo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Impact of Events Scale - Revised (IES-R)
Prazo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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25-item Resilience Scale (RS)
Prazo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Twenty-four-hour urinary samples
Prazo: pre-intervention and 3 months post intervention
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pre-intervention and 3 months post intervention
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10-minute segment of a seated 30-minute electrocardiogram recording session
Prazo: pre-intervention and 3 months post intervention
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pre-intervention and 3 months post intervention
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Beck Depression Inventory (BDI)
Prazo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Spielberger State Trait Anxiety Inventory (STAI)
Prazo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Daily Sleep Wake Diaries
Prazo: during intervention (weeks 1-10) and 3 months post intervention
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during intervention (weeks 1-10) and 3 months post intervention
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Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Prazo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Credibility Expectancy Questionnaire (CEQ)
Prazo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Body-Oriented State Questionnaire (BOSC)
Prazo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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5-Facet Mindfulness Questionnaire (FFMQ)
Prazo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Perceived Stress Scale (PSS)
Prazo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Yoga Follow-up Questionnaire
Prazo: 3 months post intervention
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3 months post intervention
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PTSD Checklist Civilian Version (PCL-C)
Prazo: pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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pre-intervention, 5 weeks, 10 weeks and 3 months post intervention
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sat Bir S Khalsa, Ph.D., Brigham and Women's Hospital
- Diretor de estudo: Jennifer Johnston, MA, LMHC, Northeastern University
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
- Hoge CW, Auchterlonie JL, Milliken CS. Mental health problems, use of mental health services, and attrition from military service after returning from deployment to Iraq or Afghanistan. JAMA. 2006 Mar 1;295(9):1023-32. doi: 10.1001/jama.295.9.1023.
- van der Kolk BA. Clinical implications of neuroscience research in PTSD. Ann N Y Acad Sci. 2006 Jul;1071:277-93. doi: 10.1196/annals.1364.022.
- van der Kolk BA, Roth S, Pelcovitz D, Sunday S, Spinazzola J. Disorders of extreme stress: The empirical foundation of a complex adaptation to trauma. J Trauma Stress. 2005 Oct;18(5):389-99. doi: 10.1002/jts.20047.
- Creamer M, Burgess P, McFarlane AC. Post-traumatic stress disorder: findings from the Australian National Survey of Mental Health and Well-being. Psychol Med. 2001 Oct;31(7):1237-47. doi: 10.1017/s0033291701004287.
- Seligman MEP. Learned Optimism, 2nd Edition ed. New York, NY: Pocket Books; 1998.
- Morse DR, Cohen L, Furst ML, Martin JS. A physiological evaluation of the yoga concept of respiratory control of autonomic nervous system activity. Int J Psychosom. 1984;31(1):3-19. No abstract available.
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
1 de agosto de 2009
Conclusão Primária (Real)
1 de maio de 2012
Conclusão do estudo (Real)
1 de maio de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
13 de agosto de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de agosto de 2009
Primeira postagem (Estimativa)
20 de agosto de 2009
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
20 de março de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de março de 2013
Última verificação
1 de março de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2009-P-000717
- 08144033
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