跳至主要内容
临床试验/NCT01091363
NCT01091363已完成不适用

A Randomized Controlled Clinical Trial of a Combination of Pharmacotherapy and Culturally Tailored Cognitive Behavior Therapy With Korean Americans

University of Massachusetts, Boston2 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2009年10月最近更新:
适应症
干预措施

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

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

Experimental

deep cultural therapy

干预措施: Deep Cultural (Behavioral)

standard arm

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sun S Kim

Study Principle Investigator

University of Massachusetts, Boston

研究点 (2)

Loading locations...

相似试验