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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01789125
Smoking Termination / Anxiety Reduction Treatment (ST/ART) (START)
19 de abril de 2019 actualizado por: Michael J. Zvolensky, Ph.D., University of Houston
Augmenting Smoking Cessation With Transdiagnostic CBT for Smokers With Anxiety
The primary aim of this research study is to enhance smoking cessation outcome among smokers with anxiety disorders.
The investigators are comparing two group treatment approaches: (1) An educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An integrated smoking cessation and anxiety treatment program (START).
Both treatments also utilize nicotine replacement therapy.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
The chief objective of the proposed study is to develop an integrated standard smoking cessation treatment and transdiagnostic anxiety disorder treatment for smokers with anxiety disorders.
The intervention is designed to promote smoking cessation and reduce (a) anxiety symptoms, (b) depression, and (c) the cognitive factor of AS, thereby reducing three notable emotional risk factors of smoking cessation relapse, while at the same time targeting (d) nicotine withdrawal symptoms.
The intervention development approach will follow a staged model consistent with NIH guidelines for developing and standardizing behavioral therapies.
During the first year, startup activities will include piloting the integrated intervention on a subset of individuals, soliciting internal and external expert consultant and participant feedback, and development of the final treatment protocol.
The goal during this phase of the project will be to establish feasibility of treatment delivery, participant acceptability, and potential for an effect.
During the following two years, a pilot two-arm efficacy study will be undertaken.
The two arms of the randomized trial (RCT) will be: (a) the integrated smoking cessation treatment, consisting of a standard smoking cessation intervention (i.e., CBT-Smoking + Nicotine Replacement Therapy [NRT]) plus a transdiagnostic CBT for anxiety (Smoking Termination and Anxiety Reduction Treatment; START) or (b) standard smoking cessation intervention (i.e., CBT-Smoking + NRT) plus contact control (ST+CTRL).
The primary outcomes will be short- and long-term point prevalence abstinence (PPA) and time to first smoking lapse and relapse.
The following specific aims are proposed: 1.
To compare, in a pilot RCT, the effects of START vs. ST+CTRL on smoking cessation outcomes: Short- and longterm PPA.
The investigators expect that PPA will be higher, both in the short- and longterm, for those in the START condition compared to those in ST+CTRL.
Similarly, The investigators expect the rate of decline in abstinence over time to be slower in START than in ST+CTRL Time to first smoking lapse and time to smoking relapse.
The investigators expect mean time to first lapse and to relapse to be greater for those in the START compared to those in the ST+CTRL condition.
2. To compare, in a pilot RCT, the effect of START vs. ST+CTRL on the remission of anxiety disorders, anxiety and depressive symptoms, anxiety sensitivity, and nicotine withdrawal symptoms.
3. To explore the mechanisms by which START improves smoking cessation.
The investigators expect that: Treatments over time will directly cause changes in abstinence and withdrawal symptoms, AS, anxiety symptoms, depressed mood (i.e., the proposed mediators of change in abstinence); The effect of treatment on anxiety symptoms and depressed mood will be moderated by treatment condition, such that those receiving START will improve more than those receiving ST+CTRL Changes in each mediator over time will lead to improvements in abstinence over time, and decreases in AS over time will lead to improvements in anxiety symptoms and depressed mood over time.
Tipo de estudio
Intervencionista
Inscripción (Actual)
74
Fase
- Fase 1
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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Texas
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Houston, Texas, Estados Unidos, 77204
- Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston
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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 Criteria:
- Ages 18-65 years old
- Capable of providing informed consent
- Willing to attend all study visits and comply with the protocol
- Daily smoker for at least one year
- Currently smoke an average of at least 6 cigarettes per day
- Report a motivation to quit smoking in the next 6 weeks of at least 5 on a 10-point scale
Exclusion Criteria:
- Use of other tobacco products
- Current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol
- Currently suicidal or high suicide risk
- Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt
- Unwilling to cease use of benzodiazepines or other fast-acting anxiolytics
- Concurrent psychotherapy initiated in the past three months, or ongoing anxiety psychotherapy
- Current or intended participation in a concurrent substance abuse treatment
- Insufficient command of English to participate in assessment or treatment
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 |
|---|---|
|
Comparador activo: Psicoterapia de apoyo educativo
Psicoterapia basada en la educación y programa estándar de tratamiento para dejar de fumar
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Otros nombres:
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Comparador activo: Smoking Termination and Anxiety Reduction Treatment
Cognitive-behavioral treatment program that blends smoking cessation and anxiety reduction treatment strategies
|
Otros nombres:
Integrated smoking cessation and anxiety reduction treatment
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Short- and long-term point prevalence abstinence
Periodo de tiempo: Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.
|
The investigators will ask participants various questions about their abstinence.
The investigators will measure the length of time between when treatment ends and when/ if they start smoking again.
The unit of measure will be length of time in days.
|
Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to first smoking lapse and relapse
Periodo de tiempo: Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.
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The investigators will ask participants to record the time (in days) of their first (if any) lapse in smoking and their relapse.
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Change from baseline at 1, 2, 4, 8, 10, 16, and 24 weeks post quit day.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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.
Enlaces Útiles
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 2012
Finalización primaria (Actual)
1 de diciembre de 2015
Finalización del estudio (Actual)
1 de junio de 2016
Fechas de registro del estudio
Enviado por primera vez
8 de febrero de 2013
Primero enviado que cumplió con los criterios de control de calidad
8 de febrero de 2013
Publicado por primera vez (Estimar)
11 de febrero de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de abril de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
19 de abril de 2019
Última verificación
1 de abril de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Desordenes mentales
- Desórdenes de ansiedad
- 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
- 1R34DA03131301A1
- R34DA031313 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Data will be made available upon request.
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. .