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Post Acute Coronary Event Smoking Study (PACES)

10 de enero de 2017 actualizado por: Andrew Busch, The Miriam Hospital

Integrated Smoking Cessation and Mood Management for Cardiac Patients

Smoking and depressed mood are both predictive of mortality following Acute Coronary Syndrome. However, to date, no counseling treatment has been designed to target smoking cessation and manage mood in this population. This trial will test such a treatment based on Behavioral Activation, an approach that has shown promise as an integrated treatment for smoking and mood management in other populations.

Descripción general del estudio

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

Intervencionista

Inscripción (Actual)

65

Fase

  • No aplica

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

    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02903
        • The Miriam 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:

  • 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

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: 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.
Baseline to 6 months
Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)
Periodo de tiempo: Baseline to 6 months
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.
Baseline to 6 months
Positive Affect
Periodo de tiempo: Baseline to 6 months
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
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

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

Patrocinador

Investigadores

  • Investigador principal: Andrew M Busch, Ph.D, The Miriam Hospital Centers for Behavioral and Preventive Medicine

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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 2013

Finalización primaria (Actual)

1 de abril de 2015

Finalización del estudio (Actual)

1 de abril de 2015

Fechas de registro del estudio

Enviado por primera vez

15 de octubre de 2013

Primero enviado que cumplió con los criterios de control de calidad

15 de octubre de 2013

Publicado por primera vez (Estimar)

17 de octubre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

12 de enero de 2017

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

10 de enero de 2017

Última verificación

1 de enero de 2017

Más información

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. .

Ensayos clínicos sobre Behavioral Activation (BA)

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