Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy
4 de agosto de 2014 actualizado por: Eric Garland, Florida State University
Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy: Exploration of Cognitive, Affective, and Physiological Mechanisms
Persons suffering from chronic pain who are treated with long-term opioid therapy are at risk of misusing prescription opioids and developing opioid addiction.
Moreover, long-term use of opioids may result in hyperalgesia, which exacerbates opioid craving and consumption.
Mindfulness interventions have been shown reduce chronic pain symptoms, addictive processes, and substance use.
The investigators hypothesize that relative to a support group control condition, participation in a novel mindfulness-oriented cognitive intervention, Mindfulness-Oriented Recovery Enhancement (MORE), will result in improved well-being and decreased pain, opioid craving, and opioid misuse behaviors among chronic pain patients receiving opioid therapy.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Few behavioral treatments target the cognitive-affective mediators of opioid misuse and addiction in chronic pain patients.
As such, novel, multimodal interventions are needed to effectively target key mechanisms in the risk chain from chronic pain to opioid misuse and addiction.
The secondary aim of this study is to explore possible cognitive, affective, and psychophysiological mediators of intervention effects on pain, opioid craving, opioid misuse behaviors, and well-being.
Tipo de estudio
Intervencionista
Inscripción (Actual)
115
Fase
- Fase 1
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
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Florida
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Tallahassee, Florida, Estados Unidos, 32306-2570
- FSU College of Social Work
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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
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- chronic pain diagnosis (ICD-9 diagnoses 338.xx)
- treatment with prescription opioids for > 3 months
Exclusion Criteria:
- prior mindfulness training
- persons who are experiencing acute opioid withdrawal
- suicidal ideation
- psychosis
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 |
|---|---|
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Experimental: Mejora de la recuperación orientada a la atención plena
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MORE is a multimodal, dual-process group intervention involving mindfulness training, cognitive restructuring, and positive emotion induction.
MORE consists of eight, weekly, two-hour group sessions led by a trained therapist.
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Comparador activo: Conventional Support Group (SG)
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The control arm will participate in a time-matched, conventional SG led by a Master's level therapist, discussing topics pertinent to chronic pain and opioid misuse.
The SG format is adapted from the support group detailed in the evidence-based, Matrix Intensive Outpatient Treatment manual.
The SG consists of eight, weekly, two-hour sessions.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain severity, pain functional interference
Periodo de tiempo: Baseline, immediately following treatment, and at 3 month follow-up
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Change in pain severity, functional interference, and relief from pain treatments measured on the Brief Pain Inventory-Short Form.
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Baseline, immediately following treatment, and at 3 month follow-up
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Opioid craving
Periodo de tiempo: Baseline, immediately following treatment, and at 3 month follow-up
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Change in opioid craving as measured by the Obsessive-Compulsive Drug Use Scale and a single-item measure of instantaneous craving.
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Baseline, immediately following treatment, and at 3 month follow-up
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Opioid misuse behaviors
Periodo de tiempo: Baseline, immediately following treatment, and at 3 month follow-up
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Change in opioid misuse behaviors as measured by the Current Opioid Misuse Measure
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Baseline, immediately following treatment, and at 3 month follow-up
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Well-being
Periodo de tiempo: Baseline, immediately following treatment, and at 3 month follow-up
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Change in well-being as measured by the WHO-5
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Baseline, immediately following treatment, and at 3 month follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Attentional bias
Periodo de tiempo: Baseline and immediately following treatment
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Change in attentional bias as measured by a dot probe task
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Baseline and immediately following treatment
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Psychophysiological cue-reactivity
Periodo de tiempo: Baseline and immediately following treatment
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Change in psychophysiological cue-reactivity
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Baseline and immediately following treatment
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Emotional response inhibition
Periodo de tiempo: Baseline and immediately following treatment
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Change in emotional response inhibition
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Baseline and immediately following treatment
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Pain coping strategies
Periodo de tiempo: Baseline, intervention midpoint, and immediately following treatment
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Change in reinterpretation of pain sensations, catastrophizing, and suppression.
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Baseline, intervention midpoint, and immediately following treatment
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Anhedonia
Periodo de tiempo: Baseline and immediately following treatment
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Change in anhedonia
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Baseline and immediately following treatment
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Fear of pain
Periodo de tiempo: Baseline and immediately following treatment
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Change in fear of pain
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Baseline and immediately following treatment
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Mindfulness
Periodo de tiempo: Baseline, intervention midpoint, and immediately following treatment
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Change in mindfulness measured by the Five-Facet Mindfulness Questionnaire and the Toronto Mindfulness Scale
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Baseline, intervention midpoint, and immediately following treatment
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Positive reappraisal
Periodo de tiempo: Baseline and immediately following treatment
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Change in positive reappraisal
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Baseline and immediately following treatment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Eric L Garland, PhD, Florida State University
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 octubre de 2011
Finalización primaria (Actual)
1 de julio de 2013
Finalización del estudio (Actual)
1 de julio de 2013
Fechas de registro del estudio
Enviado por primera vez
4 de enero de 2012
Primero enviado que cumplió con los criterios de control de calidad
5 de enero de 2012
Publicado por primera vez (Estimar)
6 de enero de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
6 de agosto de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
4 de agosto de 2014
Última verificación
1 de agosto de 2014
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- DA032517-01
- R03DA032517 (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. .