A Randomized Controlled Clinical Trial of a Combination of Pharmacotherapy and Culturally Tailored Cognitive Behavior Therapy With Korean Americans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- 12-month Abstinence
研究概览
简要总结
Nicotine dependence is very common among Asian Americans; yet, research on understanding and treating nicotine dependence in this group is almost nonexistent. The proposed study is a first attempt to develop a smoking cessation program that is tailored to Korean-culture specific aspects. It is proposed that Korean Americans who receive a culturally tailored smoking cessation program will be more likely to have prolonged abstinence at 12-month follow-up than their counterparts who receive brief cessation counseling. Subjects in both arms receive nicotine patches for 8 weeks. Self-reported abstinence is validated with exhaled carbon monoxide and salivary cotinine tests.
详细描述
Korean men have been known for very high smoking rates and the highest cancer death smoking-attributable fraction. In contrast, Korean women reportedly smoke at low rates compared to the general U.S. population. However, recent population-based survey data indicate steady increases in smoking prevalence of Korean American women. Particularly, it has been found that they tend to initiate smoking as they acculturate into social norms of American women. Preliminary data of the applicant and others suggests interventions must be culturally adapted and a motivation-based and family-involved approach is most promising. The training plan will help the applicant develop an independent program of drug abuse research that focuses on better understanding and treating tobacco dependence among Asian Americans, including evaluating culturally competent and gender-specific interventions. The research plan will examine the impact of culture and gender on nicotine dependence and utilize National Institute on Drug Abuse behavioral therapy development methods. The proposed research plan has two-phases and evaluates tobacco dependence treatment with Korean Americans (N = 164, 50% women). Phase 1 is a no-control group study (Stage Ia) that is aimed at developing an intervention manual of Group-based Motivational Interviewing (GMI) intervention, therapists' adherence and competence scales, training program, and small feasibility intervention study with 20 Korean-American (offered separately for men and women). Phase 2 is a randomized controlled trial (Stage Ib) with 144 Korean Americans that is conducted to assess feasibility and relative effectiveness of the GMI behavioral intervention in conjunction with Nicotine Replacement Therapy (NRT) in comparison with a brief group medication management of NRT. Gender-interaction effects of psychosocial variables on treatment outcomes will be assessed, including acculturation and depression. This award will help prepare the applicant for an independent research career focusing on Asian Americans and Nicotine Dependence, including adapting and testing new interventions for different populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Korean-speaking Koreans who:
- •Are ages of 18 and older
- •Have been smoking at least 10 or more cigarettes on average per day for the past 30 days; AND
- •Are willing to quit smoking and receive NRT
排除标准
- •Inability to speak and understand Korean or English
- •Involvement in behavioral or other pharmacological smoking cessation programs
- •History of serious cardiac diseases and/or presence of skin diseases (see Human Subjects); OR
- •Pregnancy, lactation or plans to become pregnant in the next 12 months
研究组 & 干预措施
deep cultural arm
deep cultural therapy
干预措施: Deep Cultural (Behavioral)
standard arm
brief cessation counseling
干预措施: Standard (Behavioral)
结局指标
主要结局
12-month Abstinence
时间窗: 12 months
The number of participants who had maintained smoking abstinence for the past 12 months
次要结局
- Perceived Family Norm Toward Quitting Smoking(6-month follow-up)
研究者
Sun S Kim
Study Principle Investigator
University of Massachusetts, Boston
