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Helping Veterans Quit Smoking by Improving Their Sleep (ISCWCBTI)

1 de diciembre de 2014 actualizado por: US Department of Veterans Affairs

Improving Smoking Cessation Outcomes in PTSD With CBT for Insomnia

This project is designed to determine whether an efficacious behavioral intervention for insomnia can improve the quit rates achieved by an efficacious smoking cessation program aimed at PTSD patients ("Integrated Care"). A second aim is to deepen our understanding of the mechanisms relating sleep and smoking in PTSD.

Descripción general del estudio

Descripción detallada

In summary, participation will involve a screening period of approximately one week, six weeks of temporally aligned IC ("Integrated Care" - manualized smoking cessation treatment integrating components of behavioral treatment for PTSD) and behavioral sleep treatments (Cognitive-Behavioral Treatment for Insomnia or CBTI), and follow-up telephone interviews at two months and six months.

Screening: Patients in the VA Palo Alto inpatient psychiatry and domiciliary programs indicating interest in quitting cigarette smoking will be pre-screened by the Medical Director to determine whether an individual's psychiatric conditions contraindicates use of bupropion or NRT (Nicoderm). Patients interested in quitting will be referred to the study coordinator. Coordinator will be notified whether medication or NRT is contraindicated for participant and/or of a diagnosed sleep disorder (treated or untreated) other than insomnia.

Continuing participants will be consented and then complete 24 hours of cued symptom reporting using a personal digital assistant (PDA) to verify their capacity to adhere to this component of the study protocol. Continuing participants will undergo a research psychodiagnostic assessment followed by an ambulatory screening polysomnogram (PSG) to exclude undiagnosed sleep disorders. (Participants exhibiting evidence of sleep disorder will be referred for a clinical sleep study.) Screening assessments and psychodiagnostics have been sequenced with the aim of minimizing burden for those excluded.

Participants meeting all inclusion and exclusion criteria will be randomized to IC+CBTI or IC+Desensitization Treatment for Insomnia (DTI: a manualized placebo control intervention). They will meet twice with the IC therapist to complete IC sessions 1 and 2. Over the course of these sessions, they will negotiate a quit date at least three weeks from that time and at least four weeks prior to their projected discharge from inpatient treatment. (Inpatient stays in both of these programs average thirteen weeks.) IC sessions 3 and 4 will be evenly spaced between IC session 2 and the planned quit date. Three weeks prior to their quit date, they will initiate sleep treatment (sessions 1 and 2) and nightly mattress actigraphy. Two weeks prior to their quit date they will begin PDA-based EMA. One to two weeks prior to their quit date, they will commence bupropion and receive sleep treatment session 3. One week prior to their quit date they will receive sleep treatment session 4. On their quit date they will begin NRT. Thereafter, for weeks four through six, they will receive IC sessions five through eight and sleep treatment session five through seven, respectively. At the end of week six, they will receive IC session eight which will also serve as the 3 week assessment of smoking status (the primary outcome assessment of the study). (Note that the first planned assessment of cessation status will occur prior to the expected discharge date for all participants.) The final research interventions will be telephone interviews at two months and six months. Salivary cotinine samples will be obtained at the end of each post-quit week (only if the participant is not using NRT) the last corresponding to the primary outcome assessment, at both telephone follow-up smoking status assessments (by mail).

Tipo de estudio

Intervencionista

Inscripción (Actual)

142

Fase

  • Fase 2

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

    • California
      • Palo Alto, California, Estados Unidos, 94304-1290
        • VA Palo Alto Health Care System, Palo Alto, CA

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:

  • Potential participants will be smokers who have smoked at least 10 cigarettes per day for the past year,
  • are motivated to make a smoking cessation attempt,
  • are na ve to behavioral sleep treatment and are willing to be randomly assigned to either one of the sleep treatment arms.
  • Participants must meet the criteria for PTSD and or partial PTSD.
  • They will indicate a willingness to forgo the use of all alternative tobacco products during their attempt to quit cigarettes.
  • They will be fluent in English.

Exclusion Criteria:

  • Candidates who meet DSM-IV criteria for schizophrenia,
  • current manic syndrome,
  • lifetime but not current PTSD or partial PTSD,
  • or current substance abuse/dependence will be excluded.
  • positive Brain Injury Screen will not result in exclusion from the study.
  • subjects reporting a prior diagnosis of severe obstructive sleep apnea will be excluded unless they have been successfully treated via weight loss, surgery, or continuous positive airway pressure to which they are reliably adherent.
  • We expect these criteria to exclude 15 to 20% of potential participants.

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Arm 1
Integrated Care + Cognitive-Behavioral Treatment for Insomnia
A PTSD-aware smoking cessation intervention developed by Miles McFall, PhD.
A behavioral treatment aimed at improving sleep continuity and subjective sleep through stimulus control, sleep restriction, and attenuation of maladaptive sleep-related cognitions.
Comparador falso: Arm 2
Integrated Care + Desensitization Treatment for Insomnia
A PTSD-aware smoking cessation intervention developed by Miles McFall, PhD.
A credible sham treatment for insomnia matching CBTI in treatment time, patient expectations, therapist expectations, etc.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
seven-day point prevalence abstinence
Periodo de tiempo: 21 days post-quit-day
21 days post-quit-day

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Steven H. Woodward, PhD, VA Palo Alto Health Care System, Palo Alto, CA

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 2011

Finalización primaria (Actual)

1 de junio de 2013

Finalización del estudio (Actual)

1 de junio de 2013

Fechas de registro del estudio

Enviado por primera vez

23 de diciembre de 2010

Primero enviado que cumplió con los criterios de control de calidad

23 de diciembre de 2010

Publicado por primera vez (Estimar)

24 de diciembre de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

2 de diciembre de 2014

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

1 de diciembre de 2014

Última verificación

1 de diciembre de 2014

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • SPLA-09-S09
  • 1I01CX000301-01 (Otro número de subvención/financiamiento: DVA)

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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