Clinical Trials Directory

Trials / Completed

CompletedNCT01422239

A Smoking Cessation Treatment for Adult Women

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
28 (actual)
Sponsor
Yale University · Academic / Other
Sex
Female
Age
18 Years – 64 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to develop and pilot test a smoking cessation counseling that focuses on the perceived risks of quitting smoking (e.g., weight gain, managing cravings and negative affect, loss of enjoyment). Aim 1: To develop the risk-based smoking cessation intervention. Aim 2: To examine whether manualized smoking cessation counseling about the perceived risks of quitting is feasible to administer and acceptable to adult women who want to quit smoking. Aim 3: To examine smoking cessation outcomes for women who receive the risk-based treatment in comparison to standard smoking counseling. It is expected that women who receive risk-based counseling will show better quit rates and a longer time to relapse than women who receive standard treatment.

Detailed description

The purpose of this treatment development study is to design and pilot test a smoking cessation intervention in which counseling sessions are tailored to individual smokers' perceived risks of quitting. The feasibility, acceptability, and efficacy of the novel treatment will be examined through a pilot study in which female smokers will be randomly assigned to receive either the tailored treatment or a standard treatment. It is expected that participants receiving the tailored treatment will show higher rates of smoking abstinence than participants receiving the standard smoking cessation treatment at the end of the 8-week treatment and at one month follow-up.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTailored treatment8 sessions of individual behavioral counseling. The first 3 sessions will be 45 minutes long and include 30 minutes tailored to the perceived risks of quitting most strongly held by each participant. The final 5 sessions will be 30 minutes long and include material from the Mayo Clinic's smoking cessation manual.
BEHAVIORALStandard Treatment8 sessions of individual behavioral counseling. The first 3 sessions will be 45 minutes long and include 30 minutes focused on the benefits of quitting smoking. The final 5 sessions will be 30 minutes long and include material from the Mayo Clinic's smoking cessation manual.

Timeline

Start date
2011-01-01
Primary completion
2012-12-01
Completion
2012-12-01
First posted
2011-08-23
Last updated
2020-04-20
Results posted
2013-06-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01422239. Inclusion in this directory is not an endorsement.