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Pain and Stress Management for Fibromyalgia

15 de marzo de 2016 actualizado por: Mark A. Lumley, Wayne State University

Emotional Exposure and Cognitive Behavioral Therapies for Fibromyalgia

This interventional, randomized controlled study seeks to test the effects of an innovative emotional exposure and processing treatment that targets stress resolution, by comparing it with cognitive-behavioral therapy and a Fibromyalgia education comparison condition. The investigators also will test proposed mediators of the intervention, including improved autonomic regulation, and explore which subgroups of patients benefit the most from each approach.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

230

Fase

  • Fase 2

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
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48106
        • University of Michigan Medical Center
      • Detroit, Michigan, Estados Unidos, 48202
        • Wayne State University
      • Southfield, Michigan, Estados Unidos, 48075
        • St. John Providence Hospital

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 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Meet Fibromyalgia (FM) criteria of the American College of Rheumatology (ACR)either:

    • 1990 ACR criteria including tender points
    • 2010 ACR modified clinical criteria that does not include tender points

Exclusion Criteria:

  • Co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus
  • Other serious medical conditions that can impair health status independent of FM
  • Current psychotic disorders (schizophrenia, bipolar disorder, etc.),dissociative identity (multiple personality) disorder, active suicide risk
  • Alcohol/drug dependence in past 2 years
  • Cognitive impairment or dementia
  • Currently have pending (or recently received - within 2 years) FM pain related disability or workman's compensation
  • Unable to fluently read or converse in English
  • Planning to move from the area in the next 14 months
  • Judgment of principle investigator as not appropriate for this trial or all intervention arms

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: Stress and Emotions
Seeks to reduce stress and physical symptoms by helping individual become aware of their emotions, express them, and resolve emotional difficulties. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others.
Conductual: Stress and Emotions
Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
Comparador activo: Thoughts and Behaviors
Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms of fibromyalgia. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking.
Conductual: Thoughts and Behaviors
Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
Comparador activo: Brain and Body
Seeks to help individuals improve health by educating about fibromyalgia so that one can better understand and more effectively communicate about their health. It will explain the latest scientific information about fibromyalgia, including its causes, the role of the nervous system and body, various medical and alternative treatments, and how to understand research findings.
Conductual: Brain and Body
Focus on the empowering patients by providing the latest scientific information about fibromyalgia, including causes, the role of the nervous system, and various treatments.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Brief Pain Inventory
Periodo de tiempo: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
SF-12
Periodo de tiempo: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
PROMIS Fatigue short form
Periodo de tiempo: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Pittsburgh Sleep Quality Index
Periodo de tiempo: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Center for Epidemiological Studies - Depression Scale
Periodo de tiempo: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Generalized Anxiety Disorder - 7
Periodo de tiempo: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Positive and Negative Affect Schedule
Periodo de tiempo: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Satisfaction with Life Scale
Periodo de tiempo: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Multiple Ability Self-Report Questionnaire
Periodo de tiempo: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Patient Global Assessment of Change
Periodo de tiempo: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Health Care Utilization Scale
Periodo de tiempo: Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Baseline, post-treatment, 6 months post-treatment (primary endpoint), and 12 months post-treatment
Real-time Physical Activity (Actiwatch)
Periodo de tiempo: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Heart Rate Variability
Periodo de tiempo: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Levels of Emotional Awareness Scale
Periodo de tiempo: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Emotional Expressivity Scale
Periodo de tiempo: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Ambivalence over Emotional Expression
Periodo de tiempo: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Toronto Alexithymia Scale-20
Periodo de tiempo: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Impact of Events Scale - Revised
Periodo de tiempo: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
BBCA - short form
Periodo de tiempo: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Pain Catastrophizing
Periodo de tiempo: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Beliefs in Pain Control Questionnaire
Periodo de tiempo: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Communication Thoughts and Feelings Questionnaire
Periodo de tiempo: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Experimental (thumb nail pressure) threshold and tolerance ratings
Periodo de tiempo: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
2010 ACR modified clinical criteria for FM, including widespread pain index
Periodo de tiempo: Baseline, post-treatment, and 6 months post-treatment (primary endpoint)
Baseline, post-treatment, and 6 months post-treatment (primary endpoint)

Colaboradores e Investigadores

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

Patrocinador

Wayne State University

Colaboradores

University of Michigan
St. John Providence Hospital

Investigadores

  • Investigador principal: Mark A Lumley, Ph.D., Wayne 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 mayo de 2011

Finalización primaria (Actual)

1 de julio de 2015

Finalización del estudio (Actual)

1 de julio de 2015

Fechas de registro del estudio

Enviado por primera vez

2 de noviembre de 2010

Primero enviado que cumplió con los criterios de control de calidad

28 de enero de 2011

Publicado por primera vez (Estimar)

1 de febrero de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

17 de marzo de 2016

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

15 de marzo de 2016

Última verificación

1 de marzo de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1R01AR057808 (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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