Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
24 de febrero de 2021 actualizado por: Rush University Medical Center
Chronic Obstructive Pulmonary Disease (COPD) is caused primarily by smoking and smoking cessation is the first-line treatment for slowing disease progression.
Despite this, nearly 50% of COPD patients continue to smoke following diagnosis.
Smokers with COPD report high rates of co-occurring conditions - nicotine dependence, depression, and anxiety - which serve as barriers to quitting.
The current study will pilot test a behavioral intervention designed to target the common psychological factors underlying these co-occurring conditions and foster smoking cessation among COPD patients.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
Chronic Obstructive Pulmonary Disease (COPD) is caused primarily by smoking and smoking cessation is the first-line treatment for slowing disease progression. Despite this, nearly 50% of COPD patients continue to smoke following diagnosis. Smokers with COPD report high rates of co-occurring conditions - nicotine dependence, depression, and anxiety - which serve as barriers to quitting. The current study will pilot test a behavioral intervention designed to target the common psychological factors underlying these co-occurring conditions and foster smoking cessation among COPD patients. The specific aim is to:
Aim: Develop a multi-component behavioral treatment to address psychological risk factors among COPD patients. We will conduct a component analysis using single case design experiments with 15 participants to a) examine the contribution of each treatment component to the behavioral target of smoking for affect regulation, and b) establish proof-of-concept on the clinical endpoint of initial cessation (>24 hours abstinence).
Tipo de estudio
Intervencionista
Inscripción (Actual)
18
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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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Rush University Medical Center
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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 y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
Eligible participants will be males and females who are:
- Diagnosed with COPD (as documented in electronic health record [EHR]),
- Daily cigarette smokers (5 or more cigarettes per day over past 30 days),
- Intend to quit smoking within the next 60 days,
- Report at least moderate level of smoking for affective regulation (SMQ-R coping subscale score 30 or greater),
- Have access to a smart phone, tablet, or computer, and
- Are able to communicate fluently in English
Exclusion Criteria:
- Any concurrent medical or psychiatric condition which would preclude ability to provide informed consent or perform study procedures (e.g., moderate to severe dementia and/or severe, uncontrolled schizophrenia), as determined by the treating physician or study PI.
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 de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Mindfulness
This module introduces mindfulness training skills, with the goal of cultivating nonjudgmental, present-focused experience of emotions, thoughts, and physical sensations related to cigarette smoking.
By progressing though a series of experiential exercises (e.g., awareness of the breath, anchoring in the present), this module seeks to reduce maladaptive attempts to control negative emotions and facilitate tolerance of the physical and emotional symptoms of nicotine withdrawal.
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Treatment components are cognitive-behavioral strategies adapted from the Unified Protocol (UP) for the Transdiagnostic Treatment of Emotional Disorders.
Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service guidelines, are incorporated in each treatment module.
All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their quit attempt.
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Experimental: Interoceptive Exposure (Practice Quitting)
This module introduces interoceptive exposure, a technique in which participants purposefully and systematically complete exercises to evoke physical sensations typically associated with anxiety and distress, in order to reduce fear and avoidance of these sensations.
Interoceptive exercises will focus on a gradual exposure to nicotine withdrawal symptoms, through a series of 'practice quit attempts' (i.e., brief periods of smoking abstinence without intention to permanently quit).
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Treatment components are cognitive-behavioral strategies adapted from the Unified Protocol (UP) for the Transdiagnostic Treatment of Emotional Disorders.
Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service guidelines, are incorporated in each treatment module.
All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their quit attempt.
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Experimental: Behavioral Activation (Countering Emotional Behaviors)
This module introduces behavioral activation, which seeks to increase positive emotions by systematically introducing greater engagement with natural rewards.
Treatment sessions focus on the identification of avoidance strategies, including cigarette smoking as a coping strategy for negative emotions.
The goal of this treatment module is to replace smoking with adaptive coping strategies to facilitate contact with and enjoyment of reinforcing activities that are incompatible with smoking.
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Treatment components are cognitive-behavioral strategies adapted from the Unified Protocol (UP) for the Transdiagnostic Treatment of Emotional Disorders.
Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service guidelines, are incorporated in each treatment module.
All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their quit attempt.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants Who Achieved 24-hour Smoking Abstinence at End-of-treatment
Periodo de tiempo: 24 hours post-quit date
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The clinical endpoint will be achievement of 24-hour smoking abstinence at end-of-treatment, as verified by CO < 5 ppm.
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24 hours post-quit date
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percent Change in Smoking Motives Questionnaire-Revised (SMQ-R) Average Score
Periodo de tiempo: Through active treatment phase (approximately 4 weeks)
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The secondary outcome is percent change in Smoking Motives Questionnaire-Revised (SMQ-R) average score.
The SMQ-R measures the construct of smoking for affect regulation (i.e., smoking to improve mood or reduce distress).
SMQ-R average score is computed as the average of 13 items, each assessed on a 0 to 100 scale, with higher scores indicating greater smoking for affect regulation.
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Through active treatment phase (approximately 4 weeks)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
9 de septiembre de 2019
Finalización primaria (Actual)
31 de marzo de 2020
Finalización del estudio (Actual)
31 de marzo de 2020
Fechas de registro del estudio
Enviado por primera vez
1 de agosto de 2019
Primero enviado que cumplió con los criterios de control de calidad
1 de agosto de 2019
Publicado por primera vez (Actual)
2 de agosto de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de marzo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
24 de febrero de 2021
Última verificación
1 de febrero de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ORA # 18082201
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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