- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00133601
Cognitive Behavioral Therapy for Insomnia in Chronic Pain Patients
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Forty five subjects, both male and female, of diverse racial backgrounds, ages >25 with insomnia secondary to pain will be recruited from the Pain Clinic at URMC and from the community at large via advertisements and solicited primary care referrals to participate in a parallel-groups, randomized, single blind, controlled trial. Protocol eligible subjects (as determined via a phone screen interview or by responses to our web based screening questionnaire) will be evaluated in-lab. The screen will determine whether subjects have chronic insomnia secondary to pain and do not meet any of the exclusion criteria. Once found to be study eligible, they are given an appointment for the reading and signing of the consent and the intake interview. The in-lab intake interview includes the administration of a broad battery of self-report instruments. Following the clinical interview, subjects will undergo a physical exam. The history (to include drug and ETOH use) and physical examination will include blood and urine chemistries to rule out any acute or unstable medical co-morbidity (including pregnancy). The lab work will include profiles to assess renal, liver, thyroid, and anemia as well as urine toxicology screen for illicit drug use. The lab work results will be reviewed by the Co-PI and our medical consultant. If significant abnormal findings are discovered, the subject will be referred to their primary care provider for treatment. In addition to conducting an "in-house" physical, after the subject signs a release of information, the researchers also FAX the prospective subject's primary care physician a letter asking them to confirm that the individual is eligible for the study.
If data from both these evaluations suggest that the subject is protocol eligible, according to the inclusion and exclusion criteria, the subject is asked to fill out two weeks of sleep/pain diaries. The diary data are used to "prospectively" confirm the severity and frequency of the subjects sleep complaints and as baseline data. Finally, all subjects will be evaluated by polysomnography (PSG) to assure that they do not have an occult sleep disorder. Once determined to be study appropriate, the subjects will be randomized into a treatment group. They will see the therapist weekly for 8 weeks. At 3 month and 6 month intervals after weekly therapy session end, the subject will be asked to fill out sleep diaries and wear an actiwatch for a period of two weeks.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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Rochester, New York, Estados Unidos, 14642
- University of Rochester Neurophysiology and Sleep Research Laboratory
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Ages eligible for Study: Over 25 years of age
- Chronic pain (>6 months) in the neck and back that has been diagnosed by a physician
- Insomnia (>30 minutes to get to sleep, >30 minutes wake during the night and daytime loss of function due to insomnia and pain)
Exclusion Criteria:
- Unstable medical problems
- Currently undergoing surgery or procedures for their pain or medical problems
- Head injuries
- Seizure disorders
- Taking sleeping pills
Plan de estudios
¿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 |
---|---|
Sin intervención: 2
Grupo de control
|
|
Experimental: 1
CBT-1
|
CBT-I including sleep restriction, stimulus control, sleep hygiene instructions and one session of cognitive therapy devoted to catastrophic thoughts about the consequences of insomnia.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
To determine and confirm "prospectively" the severity and frequency of the subjects sleep complaints and as baseline data.
Periodo de tiempo: 8 weeks
|
8 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michael Perlis, PhD, University of Rochester
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 (Estimar)
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
- 9080
- 5R21NR009080-02 (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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