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临床试验/NCT00634218
NCT00634218已完成2 期

REaching and Treating LGBT Smokers: The Internet

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 363 人开始时间: 2008年2月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
363
试验地点
2
主要终点
Smoking status

研究概览

简要总结

Smoking rates are significantly higher among lesbian, gay, bisexual, and transgender (LGBT) populations compared to the general population. LGBT individuals may be at increased risk for experiencing psychosocial issues, e.g., negative moods, stress, alcohol/drug use, that have been associated with smoking treatment failure in other groups of smokers. Technology, such as the Internet and telephone, can be an effective method to reach a large number of smokers and may be particularly effective in reaching hidden populations. Thus, the study seeks to examine whether Internet-based counseling and/or telephone counseling can improve quit rates for LGBT smokers.

Participants (N=600) will be randomly assigned to one of four conditions: 1) a Mail-based Self Help (MSH) treatment; 2) MSH plus an Internet-based Smoking Treatment (IST); MSH plus Telephone Counseling (TC) or 4) MSH plus IST plus TC. Participants in the MSH condition will receive a self-help smoking cessation manual. In the IST condition, participants will receive the manual plus access to an Internet-based intervention that includes social support. In the TC condition, participants will receive the manual plus 6 telephone-based counseling sessions. In the fourth condition, participants will receive the manual plus access to an Internet-based intervention plus telephone counseling. Before starting treatment, participants will complete questionnaires on smoking, nicotine dependence, demographics, negative mood, and alcohol use. Participants will be contacted at 3, 6, and 12 months after enrollment to determine whether they are smoking. The data will be analyzed to compare the efficacy of the four treatments and to examine the possible influence of existing social networks and level of negative mood on treatment outcome and to examine the possible influence of residency (rural versus urban) on use of the Internet-based treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
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

  • 18 years of age
  • identify as lesbian, gay, bisexual, or transgender
  • access to the internet
  • valid email account
  • valid telephone number
  • English speaking
  • resident of the U.S.

排除标准

  • 未提供

研究组 & 干预措施

1

Active Comparator

Mail-based Self Help (MSH) treatment. Participants will receive the self-help manual developed specifically for LGBT smokers.

干预措施: Self-Help Manual (Behavioral)

2

Active Comparator

Mail-based Self Help plus an Internet-based Smoking Treatment (IST). In the IST condition, participants will receive the manual plus access to an Internet-based intervention that includes social support.

干预措施: Mail-based Self-help plus Internet-based Smoking Treatment (Behavioral)

3

Active Comparator

Mail-based Self-Help plus Telephone Counseling (TC). In the TC condition, participants will receive a self-help manual specifically developed for LGBT smokers plus 6 telephone-based counseling sessions.

干预措施: Self-Help Manual plus Telephone counseling (Behavioral)

4

Active Comparator

Mail-based Self-Help plus an Internet-based Intervention plus Telephone Counseling. Participants will receive a self-help manual, have access to an internet-based smoking treatment and participante in 6 telephone counseling sessions.

干预措施: Self-Help Manual plus Internet-based Intervention plus Telephone Counseling (Behavioral)

结局指标

主要结局

Smoking status

时间窗: 3,6, and 12 months following enrollment.

次要结局

未报告次要终点

研究者

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

Gary Humfleet

Associate Professor

University of California, San Francisco

研究点 (2)

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