Comparative Tobacco Interventions for Individuals With Severe and Persisting Behavioral Health Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of cigarettes smoked
研究概览
简要总结
The aim of this pilot intervention is to examine the acceptability of a harm reduction intervention approach to tobacco use for individuals with serious behavioral health disorders and its association with a decrease in smoking. The intervention uses a "dynamic" approach to patient choice, allowing participants the option to explore different strategies for harm reduction, while providing support from counselors in the process. Therefore, the investigators have chosen an observational study design in order to document and explore the acceptability and outcomes of the intervention.
详细描述
Background and Significance
The high rate of combustible tobacco use among persons with schizophrenia, affective, post traumatic stress and substance misuse disorders is well documented. Over 40% of the estimated 9.8 million Americans, or 4.0% of the total population, who have serious behavioral health disorders smoke cigarettes, at a rate two to three times higher than the general population. The adverse health consequences and abbreviated lifespan for these persons is also well documented. Given the greater rate of tobacco use, persons with behavioral health disorders are at greater risk for morbidity, e.g., respiratory and cardio-vascular illness, and pre-mature mortality. The relationship of individuals in these communities to combustible tobacco in its pharmacological, sensorimotor and behavioral aspects is compelling. There is a significant literature documenting the endorsement and benefit of nicotine and smoking behavior for individuals in these communities.
Clinical or personal context contribute to the barriers in making change, e.g., the social acceptability of smoking, lack of support, poor access to interventions, the need to mitigate stress and other symptoms of serious mental illness. The need for meaningful structure and daily engagement leads many to use tobacco to fill time and as a distraction. However, many individuals express a desire to quit or further reduce their tobacco consumption. Conventional tobacco interventions and approaches, e.g., smoking cessation, quit lines, informal telephone counseling, FDA approved Nicotine Replacement Therapies (NRTs) and medications have limited documented success. Existing evidence indicates that the combination of pharmacological intervention along with behavioral support is superior to either of these interventions alone. However the behavioral support aspect is usually limited to four to eight sessions.
Local Need
As documented by the State,California has led the way in the progressive decrease in combustible tobacco use. San Francisco County has a 10.8% rate of smoking. Over 25,000 adults received service on an annual basis from the San Francisco Department of Public Health. Of these service recipients at least 6028 adults or 24% (18 or older) are smokers, 5722 persons report having never smoked and for another 7926 (31.5%) smoking status is unknown. The larger department of public health offers smoking cessation services however there are no dedicated services targeting the behavioral health service user. Tobacco use is increasingly of concern for behavioral health program administrators and managers. Recruitment of programs for this research effort was met with enthusiasm and an unambiguous expression of a need for an intensive, harm reduction approach to tobacco intervention. The local Health Department division of Behavioral Health Services maintains a dedicated Harm Reduction policy regarding substance use behaviors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who are formerly or currently being served by San Francisco Bay Area Public Health behavioral health providers. These will include individuals with psychotic, affective, anxiety, personality and substance use disorders.
- •Individuals who are not currently enrolled in another formal tobacco intervention or research study.
- •Are at least 21 years of age and able to speak English*
- •Who score in the "low to moderate dependence" range on the Fagerstrom Test of Nicotine Dependence
- •Have used tobacco for at least two years
- •Express willingness to participate at least weekly in the intervention strategy
- •Express a desire to make some change in their tobacco use pattern
- •Express some reason to change their tobacco use pattern
- •Have the cognitive capacity to be able to sign a consent to participate in the research
- •A concerted effort will be made to recruit bilingual Chinese and Spanish language staff
排除标准
- •The individual does not currently smoke tobacco
- •Individuals younger than 21 years of age at the time of enrollment
- •Who score in the "low" range on the Fagerstrom Test of Nicotine Dependence
- •Have used tobacco for less than two years;
- •Express unwillingness to participate at least weekly in the intervention strategy
- •Decline an interest in making some change in their tobacco use pattern
- •Do not indicate the cognitive capacity to be able to sign a consent to participate in the research
结局指标
主要结局
Number of cigarettes smoked
时间窗: Change in number of cigarettes smoked per day will be assessed using two time frames: 1) Baseline to 6 months post baseline; and 2) Post intervention which is change from baseline to 12 months post baseline.
Self-reported number of cigarettes smoked per day
Nicotine Dependence
时间窗: Change in nicotine dependence will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline
Fagerström Test for Nicotine Dependence, a self-reported scale rated from 0-10, with \>=5 indicating dependence (Heatherton et al., 1991).
Carbon Monoxide
时间窗: Change in carbon monoxide level will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline
Exhaled carbon monoxide level concentration reported in parts per million (ppm) using a breathalyzer assay
Salivary Tobacco Use
时间窗: Change in salivary nicotine level will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline
Salivary tobacco use level reported in nicotine metabolites (cotinine)
次要结局
- Working Alliance Inventory(Change in working alliance quality will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline.)
- Challenges to Smoking Behavior Change(Change in challenges to smoking behavior change will be assessed on two occasions: 1) during the intervention from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline.)
- Smoking Decisional Balance(Change in smoking decisional balance will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline)