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Mindfulness-Based Yoga Intervention for Women With Depression

14 de diciembre de 2015 actualizado por: University of Minnesota
The purpose of this study was to examine the efficacy of a 12-week mindfulness-based yoga intervention on depressive symptoms and rumination among depressed women.

Descripción general del estudio

Descripción detallada

This study was a prospective, randomized controlled intervention pilot study conducted in a metropolitan city in the upper Midwest of the United States. Forty women who met the criteria for depression based on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV (SCID-I; First, Spitzer, Gibbon, & Williams, 1997)were randomized to an experimental mindfulness-based yoga condition (n=20) or a walking control condition (n=20). Both programs were home-based motivational sessions delivered over the telephone and lasted 12 weeks. Assessments were conducted at baseline, three months (i.e., post-intervention), one-month follow-up (i.e., one month after the intervention ended). Participants were instructed to continue their usual depression care. The primary dependent variable was depressive symptoms based on the Beck Depression Inventory (BDI). The secondary dependent variable was rumination scores on the Ruminative Responses Scale (RRS). This protocol was approved by the University of Minnesota's Institutional Review Board (IRB). Participants completed informed consent forms sent through the mail; consent to participate in physical activity was also obtained from the participant's healthcare provider. Recruitment for this trial occurred from February, 2013 to January, 2014 and follow-up assessments were completed by May, 2014.

Tipo de estudio

Intervencionista

Inscripción (Actual)

40

Fase

  • No aplica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • 18 years of age or older
  • a personal history of depression (i.e., ever being told by a healthcare provider that they had depression or given an antidepressant for depression)
  • able to read and write in the English language
  • able to commit to two sessions (yoga or walking) per week for 12 weeks
  • demonstrate a willingness to be randomly assigned to either of the study arms
  • be yoga naïve, defined as not taking more than four yoga classes in the past two years and not more than one class in the past month.

Exclusion Criteria:

  • individuals with a history of bipolar disorder or schizophrenia and/or who had been hospitalized for a psychiatric disorder within six months prior to the eligibility screening
  • individuals not providing signed informed consent
  • individuals reporting any other health problems that would interfere with regular yoga practice or walking sessions
  • individuals who engaged in more than 90 minutes of moderate intensity physical activity per week during the month prior to the eligibility screening.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Mindfulness-based Yoga

Participants in the 12-week mindfulness-based yoga condition were guided by a gentle yoga DVD that included postures (asanas), pranayama (breathing exercises), and relaxation (meditation). Participants were asked to complete 60-75 minutes of the DVD twice per week and were encouraged to do more if they were interested.

Following the initial baseline assessment and randomization telephone interview, participants in the yoga group completed weekly 15-minute telephone sessions for the first month and bi-weekly telephone sessions for the second and third for a total of eight sessions over the 12 weeks. The mindfulness telephone sessions were modified from the Mindfulness-Based Stress Reduction.

See study arm description.
Comparador activo: Walking Control Group

The 12-week walking control condition included twice-weekly home practice with a 65-minute walking DVD (Sansone, 2008) and eight telephone sessions with the telephone counselor.

Participants were asked to complete 60 minutes of the DVD (or other walking) twice weekly and encouraged to do more if they were interested.

Participants received telephone sessions on the same schedule as the yoga condition. The education sessions covered a variety of health and wellness related topics.

See study arm description.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Beck Depression Inventory
Periodo de tiempo: 3 months
Change from Baseline Depression at 3 months
3 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Ruminative Responses Scale
Periodo de tiempo: 3 months
Change from Baseline Rumination at 3 months
3 months
Five Facet Mindfulness Questionnaire
Periodo de tiempo: 3 months
Change from Baseline Mindfulness at 3 months
3 months
Perceived Stress Scale
Periodo de tiempo: 3 months
Change from Perceived Stress at 3 months
3 months
Pittsburgh Sleep Scale
Periodo de tiempo: 3 months
Change from Baseline Sleep at 3 months
3 months
Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form
Periodo de tiempo: 3 months
Change from Baseline Quality of LIfe Enjoyment and Satisfaction at 3 months
3 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Body Mass Index
Periodo de tiempo: 3 months
Change from Baseline Body Mass Index at 3 months
3 months
7-Day Physical Activity Recall
Periodo de tiempo: 3 months
Change from Baseline Physical Activity at 3 months
3 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Silla de estudio: Beth A Lewis, PHD, L.P., University of Minnesota

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de febrero de 2013

Finalización primaria (Actual)

1 de mayo de 2014

Finalización del estudio (Actual)

1 de mayo de 2014

Fechas de registro del estudio

Enviado por primera vez

7 de diciembre de 2015

Primero enviado que cumplió con los criterios de control de calidad

14 de diciembre de 2015

Publicado por primera vez (Estimar)

15 de diciembre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

15 de diciembre de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

14 de diciembre de 2015

Última verificación

1 de diciembre de 2015

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 1203P11124

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Mindfulness-based Yoga

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