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Mechanisms of Mindfulness Training and Stress Reduction

30 de enero de 2017 actualizado por: Carnegie Mellon University
This study is a three-arm randomized controlled trial of a mindfulness stress reduction intervention, with the aim of dismantling the experience-monitoring and nonjudgmental-acceptance elements of mindfulness programs to determine the active treatment component. In addition to enhancing understanding of mechanisms underlying the effects of mindfulness interventions, identifying the therapeutic constituent(s) could inform development of targeted interventions as well as provide strategies to optimize adherence.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

There is a growing body of randomized controlled trial (RCT) evidence indicating that mindfulness training interventions may reduce stress and improve stress-related disease outcomes. Yet little is known about the underlying active training mechanisms of mindfulness training. Although it is generally believed that mindfulness training interventions foster a capacity to monitor and accept present moment experience, debate currently focuses on whether it is the capacity to both monitor and non-judgmentally accept experience that drives the salutary effects observed in mindfulness training interventions. This project will test these putative active mechanisms by comparing two different types of mindfulness meditation training programs. N=135 stressed community adults will be recruited and randomized to either two different types of 8-week Mindfulness-Based Stress Reduction (MBSR) programs or a No Treatment Control (assessment only) comparison condition. Participants will complete 3 days of daily experience sampling (Ecological Momentary Assessment) immediately before and after the 8-week intervention period to measure attentional control and stress perceptions in daily life. In order to measure psychological and HPA-axis stress reactivity to a controlled stressor, participants will also complete a standardized acute stress challenge task (the Trier Social Stress Test, TSST) immediately following the 3-day post-intervention assessment period. This project provides the first dismantling study of mindfulness meditation training, it utilizes cutting-edge daily experience sampling of real life stress (using EMA) and stress biomarkers (salivary cortisol), and will provide important initial information for designing more effective (and efficient) mindfulness training interventions in at-risk stressed patient populations.

Tipo de estudio

Intervencionista

Inscripción (Actual)

137

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • Carnegie Mellon University
      • Pittsburgh, Pennsylvania, Estados Unidos, 15232
        • University of Pittsburgh Medical Center- Center for Integrative Medicine
      • University Park, Pennsylvania, Estados Unidos, 16802
        • Pennsylvania State University

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 a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • English speaking
  • Moderate- to high-stress
  • Owns an internet-enabled smart phone

Exclusion Criteria:

  • Diagnosis of chronic mental (e.g. recurrent depression, schizophrenia, personality disorder) or physical disease (e.g. cancer, HIV, diabetes)
  • Hospitalization in past 3 months
  • Medication use that interferes with cortisol activity (e.g. corticosteroids)
  • Current oral contraceptive use
  • Pregnancy
  • Current antibiotic, antiviral, or antimicrobial treatment
  • Travel outside the country within the past 6 months to any country on the Center for Disease Control travel alert list
  • Recreational drug use, excessive alcohol or tobacco use
  • Significant experience with or daily practice of mindfulness meditation or related mind-body practice

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: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Mindfulness Training
Mindfulness training intervention consisting of eight weekly 2.5 hour group sessions, a day-long retreat in the sixth week, and daily home mindfulness meditation
Conductual: Mindfulness
Mindfulness training practices aim to foster attention and acceptance toward one's present moment experience. Mindfulness consists of two components-- (1) deploying attention to monitor one's moment-to-moment experience, and (2) fostering an attitude of acceptance toward one's moment-to-moment experience
Comparador activo: Mindful Attention Only Training
Mindful attention only training intervention consisting of eight weekly 2.5 hour group sessions, a day-long retreat in the sixth week, and daily home mindfulness meditation
Conductual: Mindfulness
Mindfulness training practices aim to foster attention and acceptance toward one's present moment experience. Mindfulness consists of two components-- (1) deploying attention to monitor one's moment-to-moment experience, and (2) fostering an attitude of acceptance toward one's moment-to-moment experience
Sin intervención: No Treatment Control Condition
No treatment participants will be informed that their participation is important and that they are requested to not seek out similar treatments during this waiting period.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Daily life stress assessed via Ecological Momentary Assessment
Periodo de tiempo: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Daily life state attention and acceptance assessed via Ecological Momentary Assessment
Periodo de tiempo: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
Subjective stress in response to social evaluative threat
Periodo de tiempo: assessed at post-intervention, which is an average of 14 weeks
assessed at post-intervention, which is an average of 14 weeks
Salivary Cortisol in response to social evaluative threat
Periodo de tiempo: assessed at post-intervention, which is an average of 14, at time 0, and 25, 35, and 60 minutes post-stress challenge
assessed at post-intervention, which is an average of 14, at time 0, and 25, 35, and 60 minutes post-stress challenge
Blood Pressure reactivity to social evaluative threat (systolic and diastolic blood pressure)
Periodo de tiempo: assessed at post-intervention, which is an average of 14 weeks, at 2-minute intervals during session
assessed at post-intervention, which is an average of 14 weeks, at 2-minute intervals during session
Sustained attention measured by the Dichotic Listening Task
Periodo de tiempo: change from baseline to post-intervention, which is an average of 14 weeks
change from baseline to post-intervention, which is an average of 14 weeks
Sustained inattentional blindness measured by the Inattentional Blindness Task
Periodo de tiempo: post-intervention only
post-intervention only

Otras medidas de resultado

Medida de resultado
Periodo de tiempo
Daily life affect assessed via Ecological Momentary Assessment
Periodo de tiempo: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
Daily life social interactions assessed via Ecological Momentary Assessment
Periodo de tiempo: change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
change from baseline 3-day period to post-intervention 3-day period, which is an average of 12 weeks
Perceived stress using the Perceived Stress Scale
Periodo de tiempo: change from baseline to post-intervention, which is an average of 14 weeks
change from baseline to post-intervention, which is an average of 14 weeks
Attentional control using the Attentional Control Scale
Periodo de tiempo: change from baseline to post-intervention, which is an average of 14 weeks
change from baseline to post-intervention, which is an average of 14 weeks
Treatment expectancies
Periodo de tiempo: post-intervention an average of 14 weeks after the baseline
post-intervention an average of 14 weeks after the baseline
Subjective responses to the training program intervention
Periodo de tiempo: composite of ratings made after each intervention lesson, an average of 10 weeks following baseline
composite of ratings made after each intervention lesson, an average of 10 weeks following baseline
Mindfulness using the Mindful Attention Awareness Scale
Periodo de tiempo: change from baseline to post-intervention, which is an average of 14 weeks
change from baseline to post-intervention, which is an average of 14 weeks

Colaboradores e Investigadores

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

Patrocinador

Carnegie Mellon University

Colaboradores

University of Pittsburgh
Penn State University

Investigadores

  • Silla de estudio: Wendy Weber, Ph.D., National Center for Complementary and Integrative Health, National Institutes of Health

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 julio de 2015

Finalización primaria (Actual)

1 de enero de 2017

Finalización del estudio (Actual)

1 de enero de 2017

Fechas de registro del estudio

Enviado por primera vez

7 de julio de 2015

Primero enviado que cumplió con los criterios de control de calidad

16 de julio de 2015

Publicado por primera vez (Estimar)

20 de julio de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

1 de febrero de 2017

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

30 de enero de 2017

Última verificación

1 de enero de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1R21AT008493-01A1 (Subvención/contrato del NIH de EE. UU.)

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. .

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