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Efficacy of Yoga as a Complementary Therapy for Smoking Cessation

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Qué se está evaluando

Smoking Cessation

+ Yoga

+ Smoking Cessation

ConductualOtro
Quiénes están siendo reclutados

Trastornos Mentales

+ Trastorno por uso de tabaco

De 18 a 65 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Intervencional
Inicio del estudio: julio de 2012
Ver detalles del protocolo

Resumen

Patrocinador PrincipalThe Miriam Hospital
Última actualización: 19 de julio de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de julio de 2012

Fecha en la que se inscribió al primer participante.

Despite the existence of effective medications for smoking cessation, approximately 50-80% of smokers attempt to quit without using pharmacotherapy. Efforts to encourage medication use during cessation attempts have met with mixed success. Many do not use medications because of concerns about side effects, contraindications that make medication use inappropriate, and individual preferences for chemical-free quit attempts. This leaves many smokers seeking an effective alternative to assist them in attempting to quit smoking. Each year, over 41% of smokers report failed attempts to quit smoking. Thus, effective non-pharmacological interventions to increase rates of successful cessation are greatly needed. Our research, and the research of other investigators, has demonstrated that traditional (Western) exercise (e.g., brisk walking, bicycling) improves smokers' ability to successfully quit. Exercise may help smokers quit by reducing concerns regarding post-cessation weight gain, and by reducing nicotine withdrawal and enhancing mood. Recent research suggests that yoga is an acceptable and potentially effective alternative therapy for smoking cessation for several reasons: As a form of exercise, yoga shares many of the same properties as traditional (Western) aerobic exercise in that yoga has been shown to improve mood, physical fitness, weight control, self-image and quality of life in healthy and ill populations. Moreover, features of yoga, including a focus on breathing, mental concentration, meditation, stress reduction and enhanced mood are likely to have special relevance for smokers who are trying to quit. Thus, yoga may be particularly attractive as an alternative for individuals who either cannot use medications, or who choose not to use medications while quitting. The proposed study will test the efficacy of Yoga as a complementary therapy for smoking cessation using a randomized, controlled study design. Adult smokers will be randomly assigned to either; 1) Yoga, or 2) an equal contact time Control group (CTL) given a health & wellness program to control for contact time. All participants will be provided (separately by treatment group assignment) with the same cognitive-behavioral Smoking Cessation Counseling (SCC). Smoking abstinence will be measured at the end of treatment (week 8) and at 3, 6 and 12 months follow-up. We hypothesize that abstinence will be significantly higher in the SCC+Yoga group compared to SCC+CTL. We will also test theoretically posited mediators of intervention efficacy (e.g., perceived stress, cognitive/perceptual changes), examine the cost-efficacy of the yoga intervention, and examine the relationship between maintenance of yoga practice during the post-treatment period and smoking status. This study builds on our programmatic line of research developing innovative, theory-driven smoking cessation therapies.

Patrocinador PrincipalThe Miriam Hospital
Última actualización: 19 de julio de 2021
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 255 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 18 a 65 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Trastornos MentalesTrastorno por uso de tabaco

Criterios

Inclusion Criteria: Age 18 years or older (physician clearance for age > 65) English-speaking Currently Healthy Smoking smoked 5 or more cigarettes/day Must accept randomization procedure BMI< 40 Will be Living in RI/MA/CT for next year Exclusion Criteria: Participated in any Yoga, Tai Chi, Qi Gong or Mindfulness-based therapy program twice in the past month or 10 times within the past year MD refused consent or Unable to obtain MD consent Unable to attend program due to work or home schedule Currently using medications or in active treatment to quit smoking Currently or planned participation in research or treatment programs that would interfere with this study Presence of health conditions that would make participation in yoga difficult or dangerous Medical Exclusion Criteria Cardiovascular disease Stroke/TIA Chest pain with physical activity Current or recent (< 6 months) cancer treatment Uncontrolled Hypertension Untreated major depression or hospitalization < six months Bone joint problems Liver or Kidney Disease Fainting within the past year History of seizures Balance condition that interferes with ability to exercise Respiratory Condition - COPD (e.g., emphysema requiring oxygen) Liver Disease Kidney Disease Other medical condition that would interfere with ability to exercise Hypothyroid (not on stable medication for 3 months)

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Twice weekly, 1-hour yoga classes delivered for 8 weeks combined with once-weekly, 1-hour cognitive-behavioral smoking cessation classes.

Grupo II

Comparador Activo
Twice-weekly, 1-hour Wellness classes given on a variety of health topics twice weekly to match schedule of the yoga classes, plus 1-hour per week of cognitive-behavioral smoking cessation

Objetivos del Estudio

Objetivos Primarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

The Miriam Hospital

Providence, United StatesAbrir The Miriam Hospital en Google Maps
Completado1 Centros de Estudio