A Mood Management Intervention for Pregnant Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- Number of Patients with Prolonged Abstinence
研究概览
简要总结
This proposal is aimed at testing the following hypotheses:
- Cessation rates will be significantly greater for smokers in a mood management condition versus a health & wellness condition during pregnancy and at 3 and 6 months postpartum.
- Pregnant smokers who have a higher level of depressive symptomatology will quit significantly less often in the health & wellness condition vs. mood management condition; those with a lower level of depressive symptomatology will not demonstrate this treatment difference.
- Pregnant smokers who show higher levels of current depression at the start of the intervention will quit significantly less often than those smokers with lower levels.
The mood management intervention will result in higher levels of adaptive coping behavior, self-efficacy, social support, and perceived support from the counselor, and lower levels of negative affect, rumination, and perceived stress, than the health & wellness intervention and these variables will be related to abstinence. Thus, we will evaluate the effects of the intervention (health & wellness and mood management) on hypothesized treatment mechanisms, and assess the impact of those mechanisms on abstinence.
详细描述
Before treatment begins, you will have a screening visit with the study doctor/staff, to find out if you are eligible to take part in the study. This visit will involve an in-depth interview about your history of depression and other mental health problems. If you have not yet been to a doctor, the study staff will give you a urine pregnancy test to make sure you are pregnant.You will also be asked to complete several questionnaires regarding smoking history and other areas of your daily life. The questionnaires themselves take about 30-45 minutes to complete. The visit may last between 1 1/2 and 3 1/2 hours, depending on the complexity of the interview.
If you are eligible to take part in the study, you will receive one of two types of smoking cessation counseling. In one, counseling will focus on health concerns related to pregnancy, information about smoking and pregnancy, tips for quitting, and problem-solving skills to manage situations that might be triggers for smoking. In the other, counseling will focus on the learning to manage negative moods (depressed mood, tension, anxiety), as well as providing tips for quitting smoking, problem-solving skills, and information about smoking and pregnancy. Counseling sessions for both groups will last about an hour each.
During the first counseling visit, you will set a quit date for stopping smoking.
At each of the counseling visits, you will also be asked to provide a carbon monoxide (CO) measurement. This is done by blowing into a cardboard tube attached to a CO monitor. This will show whether or not you are still smoking. You will also complete several questionnaires at every visit, which will take about 20-40 minutes. These questionnaires will include questions about your mood, confidence in quitting, smoking behavior, and social support.
Four times during the study, you will provide a saliva sample for tests to look for cotinine, a chemical produced by the breakdown of nicotine during smoking. This sample will be taken using a dental roll (cotton swab) placed in the mouth for several minutes to absorb saliva. Like the CO test, this test will help researchers measure how much you are smoking.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestation: < or = 32 weeks pregnant at baseline
- •Age: 16 years or older
- •Smoking: at least a puff of a cigarette in the past 7 days & willing to set quit date that occurs before the end of treatment.
- •English speaking & have a telephone
- •Willing to attend all sessions and have no known complications that would adversely affect attendance
- •Other: provide informed consent & agree to all assessments & study procedures
排除标准
- •Current psychotherapy
- •Involvement within one day of telephone screen with any smoking cessation activities other than those that are freely available in the public domain.
- •History of/current medical condition, or any other factor, that, in the judgment of the Principal Investigator, would likely preclude completion of study requirements.
结局指标
主要结局
Number of Patients with Prolonged Abstinence
时间窗: 3 month assessments from end of treatment
Prolonged abstinence assessed following treatment through 6 months postpartum to test effectiveness of health education versus a mood management treatment for helping pregnant women quit smoking.
次要结局
未报告次要终点