Integrated Smoking Cessation Treatment for Emotional Dysregulation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Smoking Status using the Timeline Follow-Back Assessment
研究概览
简要总结
The primary aim of this research study is to enhance smoking cessation outcome among smokers with elevated anxiety and depression. We are comparing two group treatment approaches: (1) An educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An integrated smoking cessation, and anxiety and depression management treatment program (SDAT). Both treatments also utilize nicotine replacement therapy.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-65 years old
- •Capable of providing informed consent
- •Willing to attend all study visits and comply with the protocol
- •Daily smoker for at least one year
- •Currently smoke an average of at least 6 cigarettes per day
- •Report a motivation to quit smoking in the next 6 weeks of at least 5 on a 10-point scale
- •Elevated anxiety or depression
排除标准
- •Use of other tobacco products
- •Current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol
- •Currently suicidal or high suicide risk
- •Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt
- •Concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or depression
- •Current or intended participation in a concurrent substance abuse treatment
- •Current non-nicotine substance dependence
- •Insufficient command of English to participate in assessment or treatment
研究组 & 干预措施
Depression and Anxiety Smoking Cessation Treatment
Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies
干预措施: Nicotine Patch (Drug)
Depression and Anxiety Smoking Cessation Treatment
Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies
干预措施: Depression and Anxiety Smoking Cessation Treatment (Behavioral)
Educational-Support Psychotherapy
Educational-based psychotherapy and standard smoking cessation treatment program
干预措施: Nicotine Patch (Drug)
Educational-Support Psychotherapy
Educational-based psychotherapy and standard smoking cessation treatment program
干预措施: Educational-Support Psychotherapy (Behavioral)
结局指标
主要结局
Smoking Status using the Timeline Follow-Back Assessment
时间窗: Change from baseline at 2, 4, 8, 10, 16, and 24 weeks post quit day.
Participants will report the number of cigarettes they consumed everyday since their last visit. The number of cigarettes reported will be used to determine smoking status (e.g., 0 cigarettes reported is abstinent and any cigarettes reported is currently smoking).
次要结局
未报告次要终点
研究者
Michael J. Zvolensky, Ph.D.
Hugh Roy and Lillie Cranz Cullen Distinguished University Professor
University of Houston