|
|
|
|
|
|
Sponsors and Collaborators: |
University of California, San Francisco Calilfornia Tobacco Related Disease Research Program |
Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00634218 |
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.
Condition | Intervention | Phase |
Cigarette Smoking |
Behavioral: Mail-based Self-help plus Internet-based Smoking Treatment Behavioral: Self-Help Manual plus Telephone counseling Behavioral: Self-Help Manual Behavioral: Self-Help Manual plus Internet-based Intervention plus Telephone Counseling |
Phase II Phase III |
MedlinePlus related topics: | Gay, Lesbian and Transgender Health Smoking Smoking Cessation |
ChemIDplus related topics: | Nicotine polacrilex Nicotine tartrate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Factorial Assignment |
Official Title: | REaching and Treating LGBT Smokers: The Internet |
Estimated Enrollment: | 600 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Mail-based Self Help (MSH) treatment. Participants will receive the self-help manual developed specifically for LGBT smokers.
|
Behavioral: Self-Help Manual
Participants will receive a self-help smoking cessation manual specifically developed for LGBT smokers. The manual provides information on quitting smoking and encourages the development of a personalized quit plan through various activities and exercises.
|
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.
|
Behavioral: Mail-based Self-help plus Internet-based Smoking Treatment
Participants in this condition will received a self-help manual developed specifically for LGBT smokers and access to an Internet-based smoking cessation treatment program. The website provides education and information about smoking cessation alond with development of a personalized quit plan. Participants have access to a message board where they can contact other participants.
|
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.
|
Behavioral: Self-Help Manual plus Telephone counseling
Participants will receive a self-help manual specifically developed for LGBT smokers plus 6 telephone-based counseling sessions. The counseling sessions focus on the development of a personalized plan to quit smoking and occur over a 3 month period.
|
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.
|
Behavioral: Self-Help Manual plus Internet-based Intervention plus Telephone Counseling
Participants in this condition will received a self-help manual developed specifically for LGBT smokers and access to an Internet-based smoking cessation treatment program. The website provides education and information about smoking cessation alond with development of a personalized quit plan. Participants have access to a message board where they can contact other participants. Smokers will also receive 6 telephone-based counseling sessions which occur over a 3 month period
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
-
Contact: Gary L Humfleet, Ph.D. | 415-476-7674 | ghumfleet@lppi.ucsf.edu |
United States, California | |||||
Univeristy of California, San Francisco | Recruiting | ||||
San Francisco, California, United States, 94143 | |||||
Contact: Gary Humfleet, Ph.D. 415-476-7674 ghumfleet@lppi.ucsf.edu | |||||
Principal Investigator: Gary L Humfleet, Ph.D. |
University of California, San Francisco |
Calilfornia Tobacco Related Disease Research Program |
Study website providing information and access to enrollment 
  |
Responsible Party: | University of California, San Francisco ( Gary Humfleet, Ph.D., Associate Professor ) |
Study ID Numbers: | TRDRP 15RT-0165 |
First Received: | March 4, 2008 |
Last Updated: | March 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00634218 |
Health Authority: | United States: Institutional Review Board |
|
|
|