- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01831362
Dismantling Mindfulness: Contributions of Attention vs. Acceptance
This study addresses NCCAM's request for research that investigates the neuropsychological mechanisms underlying mind-body therapies, and for precise criteria and better delineation of meditation practices.
The purpose of this study is to assess the clinical efficacy and mechanism of action of 2 component practices of "mindfulness meditation", i.e. focused awareness (FA) and open monitoring (OM) in comparison to each other and to the standard package, Mindfulness-Based Cognitive Therapy (MBCT).
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02912
- Brown University Clinical and Affective Neuroscience Laboratory
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- English-speaking
- ages 18-65
- mild-severe levels of depression or high level of negative affect
Exclusion Criteria:
Current:
- age <18 or >65
- inability to read and write in English
- Extremely severe levels of depression
- active suicidal ideation
- presence of Axis I personality disorder
- panic disorder
- post-traumatic stress disorder
- obsessive-compulsive disorder
- eating disorder, or substance abuse/dependence
- current psychotherapy
- change in antidepressant medication type or dosage in the last 8 weeks.
Lifetime history exclusions:
- bipolar disorder
- psychotic disorders
- persistent antisocial behavior or repeated self-harm,
- borderline personality disorder,
- organic brain damage
- regular meditation practice
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Focused Attention (FA)
This 8 week program consists solely of focused attention practices, i.e. selected attention to an object (breath etc) and deselection of other stimuli
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Experimental: Open-Monitoring (OM)
This 8-week program consists solely of open monitoring practices, or noticing and/or labeling the contents of ongoing experience ( thoughts, body sensations, emotions, seeing, hearing etc) without focusing on or deselecting any stimuli
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Experimental: Mindfulness-Based Cognitive Therapy (MBCT)
The 8 week MBCT program follows the 2nd Edition (2012) manual (Segal, Williams, Teasdale) and includes both focused attention and open- monitoring practices
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Inventory of Depressive Symptomatology
Periodo de tiempo: baseline, 8 weeks, 20 weeks
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30-item clinician administered interview about unipolar depression symptoms
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baseline, 8 weeks, 20 weeks
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change in Depression, Anxiety Stress Scale (DASS)
Periodo de tiempo: baseline, week 2,4,6,8, 20
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42-item self-report questionnaire on depression, anxiety and stress symptoms
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baseline, week 2,4,6,8, 20
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change in Wellbeing Scale (WBS)
Periodo de tiempo: baseline, 8 weeks, 20 weeks
|
73-item self-report questionnaire of psychological wellbeing
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baseline, 8 weeks, 20 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in alpha-theta EEG power from baseline to 8 weeks
Periodo de tiempo: baseline and 8 weeks
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Resting/spontaneous EEG power in 5-9 Hz range
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baseline and 8 weeks
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Change in Facial EMG power from baseline to 8 weeks
Periodo de tiempo: baseline and 8 weeks
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Facial EMG response to emotional (IAPS) photos (reactivity + regulation)
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baseline and 8 weeks
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Sustained Attention to response Task (SART)
Periodo de tiempo: baseline, 8 weeks
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40 minuted sustained attention, go-no-go task
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baseline, 8 weeks
|
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Difficulties in Emotion Regulation Scale (DERS)
Periodo de tiempo: baseline, 8 weeks, 20 weeks
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36-item self report of emotion regulation
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baseline, 8 weeks, 20 weeks
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Attention Control Questionnaire (Derryberry & Reed, 2002)
Periodo de tiempo: baseline, 8 weeks, 20 weeks
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20-item self report measure of attentional abilities
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baseline, 8 weeks, 20 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Five Facet Mindfulness Questionnaire (FFMQ)
Periodo de tiempo: baseline, week 3,5,7,8,20
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39-item self-report questionnaire of mindfulness skill acquisition (attention, non-reactivity)
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baseline, week 3,5,7,8,20
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Self-Compassion Scale (Neff 2003)
Periodo de tiempo: baseline, 8 weeks, 20 weeks
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26-item self report of attitudes towards oneself
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baseline, 8 weeks, 20 weeks
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Positive and Negative Affect Scale (PANAS)
Periodo de tiempo: week 1,2,3,4,5,6,7,8
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60-item self report of emotional states
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week 1,2,3,4,5,6,7,8
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Cullen B, Eichel K, Lindahl JR, Rahrig H, Kini N, Flahive J, Britton WB. The contributions of focused attention and open monitoring in mindfulness-based cognitive therapy for affective disturbances: A 3-armed randomized dismantling trial. PLoS One. 2021 Jan 12;16(1):e0244838. doi: 10.1371/journal.pone.0244838. eCollection 2021.
- Canby NK, Eichel K, Peters SI, Rahrig H, Britton WB. Predictors of Out-of-Class Mindfulness Practice Adherence During and After a Mindfulness-Based Intervention. Psychosom Med. 2021 Jul-Aug 01;83(6):655-664. doi: 10.1097/PSY.0000000000000873.
- Britton WB, Davis JH, Loucks EB, Peterson B, Cullen BH, Reuter L, Rando A, Rahrig H, Lipsky J, Lindahl JR. Dismantling Mindfulness-Based Cognitive Therapy: Creation and validation of 8-week focused attention and open monitoring interventions within a 3-armed randomized controlled trial. Behav Res Ther. 2018 Feb;101:92-107. doi: 10.1016/j.brat.2017.09.010. Epub 2017 Sep 28.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- K23AT006328-01A1 (Subvención/contrato del NIH de EE. UU.)
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