Smoking Cessation Intervention for Depressed Smokers: Treatment Development
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Abstinence Rates
研究概览
简要总结
Objectives:
Primary Aim:
To conduct a preliminary randomized trial in smokers with current recurrent major depressive disorder (MDD), current MDD with a single episode of 2 years or more, and current dysthymia comparing combined cognitive behavioral analysis system of psychotherapy (CBASP) and standard smoking cessation treatment (ST) (CBASP/ST) to combined Health Education and ST treatment (HE/ST) to:
1. Examine the effects of CBASP/ST on both short and long-term point prevalence abstinence
Secondary Aims:
- To test the hypothesis that depressed smokers in the CBASP/ST treatment will experience greater decreases in depressive symptoms from baseline to each of our follow-up assessment points, compared to depressed smokers in the HE/ST treatment, and;
- That depressed smokers in the CBASP/ST treatment will experience greater improvements in psychosocial functioning from baseline to follow-up assessment points, compared to depressed smokers in the ST treatment.
- To evaluate between subject neurophysiological predictors of abstinence at 3 and 6 months, and:
- To evaluate within-subject changes in neurophysiological responses to emotional and smoking-related stimuli across treatment sessions, and the relation of these changes to abstinence and depressive symptoms at end of treatment, and 3- and 6-months.
详细描述
During the session today, you will be asked to complete 8-9 questionnaires about smoking history, health status, current medications you are taking, your confidence in quitting smoking, symptoms of nicotine dependence and withdrawal, symptoms of depression, negative experiences during childhood, and your thoughts and feelings about work and the quality of your relationships with others. In total, the questionnaires should take about 30-45 minutes to complete. You will also blow into a machine that measures the amount of carbon monoxide in your blood (a breath test). This visit may last 1 ½ to 2 hours.
Following the session today, you will be provided with information on the results of the screening tests you completed at BCM to see whether you have a current depressive disorder or any other psychiatric disorders. You will be provided with an opportunity to discuss this information with the investigators.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 groups. If you are assigned to Group 1, you will receive counseling to help develop behavioral coping skills that will help with situations where you are tempted to smoke more (which are considered high-risk situations), combined with mood management counseling to help you develop interpersonal (communication) coping skills to help with depression and negative moods that may affect your ability to quit smoking. If you are assigned to Group 2, you will receive counseling to help develop behavioral coping skills that will help with situations where you are tempted to smoke more (which are considered high-risk situations), combined with education on the health-related effects of smoking. Participants in both groups will receive nicotine patches.
During the 5 weeks after the visit, you will have six (6) 70-minute counseling sessions.
If you are in Group 1, you will receive information on how cigarette smoking is a learned habit and a physical addiction and how the habit can be unlearned. You will receive counseling to help you identify situations that are high risk for smoking and to help you develop behavioral coping plans to decrease the chances of smoking in those situations. You will be encouraged to use these skills between sessions. You will also receive counseling to help you identify situations where you interact with others that may cause negative moods. You will be taught interpersonal coping skills to help decrease depression and negative moods and to increase your ability to quit smoking and not start again. You will be given homework assignments that will help you practice these skills between sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently meeting DSM-IV criteria for major depressive disorder, recurrent; or major depressive disorder, recurrent, in partial remission; or major depressive disorder, single episode with a duration of 2 years or more; or; dysthymic disorder.
- •Score greater than or equal to 8 on the PHQ at baseline
- •Age greater than or equal to 16
- •Smoking greater than or equal to 5 cigarettes per day
- •Willing to set a quit date within 6 weeks of baseline
- •English speaking and have a telephone
- •Willing to attend all sessions
- •Willing to provide informed consent and agree to all assessments and study procedures
排除标准
- •History of psychotic or bipolar disorder
- •Current psychotherapy
- •Current use of antidepressant
- •Current principal DSM-IV Axis I disorder other than unipolar depression or nicotine dependence
- •Involvement in any smoking cessation activities
- •Current use of nicotine replacement therapy
- •Known health or other complications that would adversely affect attendance
- •Severe levels of depressive symptoms, vegetative symptoms, and/or symptoms related to secondary psychiatric disorders that place participant at risk for harm or require immediate treatment
- •Currently at severe or extreme risk of suicide or moderate risk with resolved plans and preparation
- •Medical contraindications for use of nicotine patch, including uncontrolled heart disease, history of severe hypersensitivity to nicotine replacement products, or currently pregnant or lactating
- •11) History of current medical condition, or any other factor that, in the judgment of the principal investigator, would likely preclude completion of study requirements.
研究组 & 干预措施
CBASP + ST
Cognitive Behavioral Analysis System of Psychotherapy (CBASP) + Smoking Cessation Treatment (ST)
干预措施: Nicotine Replacement Therapy (Drug)
ST
Smoking Cessation Treatment (ST)
干预措施: Smoking Cessation Treatment (Behavioral)
ST
Smoking Cessation Treatment (ST)
干预措施: Nicotine Replacement Therapy (Drug)
CBASP + ST
Cognitive Behavioral Analysis System of Psychotherapy (CBASP) + Smoking Cessation Treatment (ST)
干预措施: CBASP (Behavioral)
CBASP + ST
Cognitive Behavioral Analysis System of Psychotherapy (CBASP) + Smoking Cessation Treatment (ST)
干预措施: Smoking Cessation Treatment (Behavioral)
结局指标
主要结局
Abstinence Rates
时间窗: Approximately each 12 weeks following end of treatment (about 6 weeks)
次要结局
未报告次要终点