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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01252966
Cognitive Training for Nicotine Dependence
12 de enero de 2017 actualizado por: University of Pennsylvania
This randomized clinical trial tested the effects of a computerized (web-based) cognitive training intervention on smoking cessation.
All participants received 8 weeks of standard nicotine patch therapy, smoking cessation counseling, and were randomized to 1 of 2 different training programs: cognitive training vs. control training.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
213
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
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Center for Interdiscplinary Research on Nicotine Addiction, University of Pennsylvania
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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 a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion:
- Healthy male and female treatment-seeking smokers who are between 18 and 65 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months
- Plan to live in the area for at least the next 8 months
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form
- Able to communicate fluently in English (speaking, writing, and reading)
- Have uninterrupted access to a home computer with sound capabilities, keyboard, mouse, and active Internet connection
- Provide a Carbon Monoxide (CO) breath test reading greater than or equal to 8 parts per million (ppm) at Intake Visit
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: Cognitive Training
Participants in this arm received computerized cognitive training in addition to nicotine patch and smoking cessation counseling.
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The computerized cognitive training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function.
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Comparador de placebos: Control Training
Participants in this arm received computerized control training in addition to nicotine patch and smoking cessation counseling
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The computerized control training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Point-prevalence Abstinence at End of Treatment
Periodo de tiempo: End of treatment (Week 12)
|
Daily smoking, from the Target Quit Date to End of Treatment (EOT), was assessed by a validated timeline follow-back measure.
Based on guidelines for smoking cessation trials, the primary outcome was 7-day point prevalence abstinence at EOT, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO <8ppm).
Following standard convention, participants who withdrew or were lost to follow-up were considered smokers.
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End of treatment (Week 12)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Point-prevalence Abstinence at 6-month Follow-up
Periodo de tiempo: 6 month follow-up
|
Daily smoking from the Target Quit Date to 6 month follow-up was assessed by a validated timeline follow-back measure.
Based on guidelines for smoking cessation trials, the secondary outcome was 7-day point prevalence abstinence at the 6 month follow-up, and abstinence was defined as no self-reported smoking (even a puff) for at least 7 days, with in-person verification by carbon monoxide breath levels (CO <8ppm).
Following standard convention, participants who withdrew or were lost to follow-up were considered smokers.
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6 month follow-up
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Cognitive Performance (Working Memory)
Periodo de tiempo: Baseline and Week 12 (EOT)
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Change in performance on the Digit Span Forward task (working memory) between Baseline and End of Treatment (Week 12).
In this task, participants are presented with a series of digits on the computer screen at one second intervals.
Participants are then required to enter the digits in order.
The number of digits in each series ranges from 3 to 7, and the maximum recall span is the length of the largest series entered correctly.
The outcome measure is the change score (calculated by subtracting the Baseline score from the end of treatment score).
Change scores can range from -4 to 4. Negative numbers indicate worse performance at EOT; positive numbers indicate better performance at EOT; and 0 indicates no change.
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Baseline and Week 12 (EOT)
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Cognitive Performance (Response Inhibition)
Periodo de tiempo: Baseline and Week 12 (EOT)
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Change in performance on the Go/No-Go Task (response inhibition) between Baseline and End of Treatment (Week 12).
In this task, participants are presented with a series of stimuli (the word "PRESS" in either green or red).
Participants are instructed to respond by pressing the spacebar when the stimulus is green, and to withhold a response when the stimulus is red.
The outcome is the change in number of commission errors (failure to withhold a response to a red stimulus) from EOT minus baseline.
The potential range for the change score is -42 to 42.
Negative numbers indicate a decrease in the number of commission errors (improved performance) from baseline to EOT; positive numbers indicate an increase in commission errors (worse performance); 0 indicates no change.
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Baseline and Week 12 (EOT)
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Cognitive Performance (Attention)
Periodo de tiempo: Baseline and Week 12 (EOT)
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Change in performance on the Continuous Performance Task (attention) between Baseline and End of Treatment (Week 12).
In this task, participants are presented with a series of letters at 2.5s intervals and are instructed to respond by pressing the space bar if the same letter appears twice in a row.
The outcome is the change in the number of commission errors (the number of times the participant responded to a non-target at EOT minus baseline).
There are a total of 125 trials, with 20 target trials (response required) and 85 non-target trials (no response required); therefore the possible range for the change score is -85 to 85. Negative numbers indicate a decrease in commission errors (better performance at EOT compared to baseline); positive numbers indicate an increase in commission errors (worse performance at EOT compared to baseline); and 0 indicates no change.
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Baseline and Week 12 (EOT)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Caryn Lerman, PhD, University of Pennsylvania
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 marzo de 2011
Finalización primaria (Actual)
1 de septiembre de 2015
Finalización del estudio (Actual)
1 de septiembre de 2015
Fechas de registro del estudio
Enviado por primera vez
1 de diciembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
1 de diciembre de 2010
Publicado por primera vez (Estimar)
3 de diciembre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
16 de enero de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
12 de enero de 2017
Última verificación
1 de enero de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 812429
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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