Reaching and Treating Lesbian, Gay, Bisexual, and Transgender (LGBT) Cigarette Smokers

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cigarette Smoking

Treatments: Behavioral: Self-Help Manual; Behavioral: Self-Help Manual plus Internet-based Intervention plus Telephone Counseling; Behavioral: Self-Help Manual plus Telephone counseling; Behavioral: Mail-based Self-help plus Internet-based Smoking Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00634218

TRDRP 15RT-0165

Details and patient eligibility

About

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.

Enrollment: 363 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

363 participants in 4 patient groups

1

Active Comparator group

Description:

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

Treatment:

Behavioral: Self-Help Manual

2

Active Comparator group

Description:

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.

Treatment:

Behavioral: Mail-based Self-help plus Internet-based Smoking Treatment

3

Active Comparator group

Description:

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.

Treatment:

Behavioral: Self-Help Manual plus Telephone counseling

4

Active Comparator group

Description:

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.

Treatment:

Behavioral: Self-Help Manual plus Internet-based Intervention plus Telephone Counseling