- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01964898
Post Acute Coronary Event Smoking Study (PACES)
Integrated Smoking Cessation and Mood Management for Cardiac Patients
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The occurrence of Acute Coronary Syndrome (ACS; unstable angina, ST and non-ST elevation myocardial infarction) can be conceptualized as a "teachable moment," whereby patients may be more receptive to smoking cessation messages. Continued smoking following ACS is an independent predictor of mortality. Depressed mood post-ACS is also predictive of mortality, and smokers with depressed mood are less likely to abstain from smoking following an ACS hospitalization. Thus, a single, integrated treatment that targets both depressed mood and smoking could be highly effective in reducing post-ACS mortality. Behavioral Activation (BA) may be an ideal treatment for this population as BA can easily integrate both mood and smoking cessation related goals and it focuses on addressing restriction of valued activities, which is common in the post-ACS population.
Thus, the overall aim of the current study is test a BA treatment manual that integrates smoking cessation and mood management for post-ACS smokers (Behavioral Activation Treatment for cardiac patients who smoke; BAT-CS). We will conduct an RCT (N=72) comparing BAT-CS (1 in-hospital session and 5-9 post-discharge sessions) to Standard Care (SC; 1 in-hospital session and 5 mailed packets of printed self-help materials). Differences in smoking cessation, depressed mood, and positive affect will be compared between conditions.
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, 02903
- The Miriam Hospital
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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:
- ACS diagnosis documented in medical record
- smoked 3 or more cigarettes per day before being hospitalized
- between the ages of 18-75
- fluent in English
- regular access to a telephone
- lives in the Providence, RI area
- willing to "strongly consider" an attempt to quit smoking at discharge
Exclusion criteria:
- limited mental competency (i.e., Mini-Mental Status exam < 20)
- presence of current psychosis, serious mental illness, or suicidality, expectation that patient will not live through 6 month study period
- currently regularly attending counseling for depression or smoking cessation and plans to continue after discharge
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 |
---|---|
Experimental: BA for cardiac patients who smoke
Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS).
Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital.
BA sessions will occur over the 12 weeks after hospital discharge.
An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
|
5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management.
BA sessions will occur over the 12 weeks after hospital discharge.
1 hour of in hospital counseling based on clinical guidelines
An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
|
Comparador activo: Standard Care
Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge.
An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
|
1 hour of in hospital counseling based on clinical guidelines
An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Smoking Cessation: 7 Day Point Prevalence Abstinence
Periodo de tiempo: 6 months
|
No smoking, not even a puff, for 7 days; verified by carbon monoxide measurement.
Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
|
6 months
|
Continuous Abstinence From Smoking Since Discharge
Periodo de tiempo: 6 months
|
Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
|
6 months
|
Time to Smoking Relapse
Periodo de tiempo: 6 months
|
Time in days to first relapse (i.e., smoking on 7 consecutive days or smoking in 2 consecutive 7 day periods), which were determined through timeline follow back interviewing.
Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
|
6 months
|
Time to Smoking Lapse
Periodo de tiempo: 6 months
|
Time in days to first lapse (i.e., first puff of a cigarette) after discharge, which were determined through timeline follow back interviewing.
Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.
|
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Depression: 9 Item Patient Health Questionnaire (PHQ-9)
Periodo de tiempo: Baseline to 6 months
|
The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms.
Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
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Baseline to 6 months
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Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)
Periodo de tiempo: Baseline to 6 months
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The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms.
Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
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Baseline to 6 months
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Positive Affect
Periodo de tiempo: Baseline to 6 months
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As measured by the 10 item Positive Affect Negative Affect Scales (PANAS).
The positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect in the past week.
Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance
|
Baseline to 6 months
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Negative Affect
Periodo de tiempo: Baseline to 6 months
|
As measured by the 10 item Positive Affect Negative Affect Scales (PANAS).
The negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect in the past week.
Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.
|
Baseline to 6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Andrew M Busch, Ph.D, The Miriam Hospital Centers for Behavioral and Preventive Medicine
Publicaciones y enlaces útiles
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
Palabras clave
Términos MeSH relevantes adicionales
- Isquemia miocardica
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- El síndrome coronario agudo
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Agentes colinérgicos
- Estimulantes ganglionares
- Agonistas nicotínicos
- Agonistas colinérgicos
- Nicotina
Otros números de identificación del estudio
- 5K23HL107391 (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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