Distress Tolerance Treatment for Weight Concern in Smoking Cessation Among Women

描述(由申请者提供)：这个K23指导下的以患者为导向的研究职业发展奖的目标是为候选人Erika Litvin博士提供必要的培训，使她能够在烟草依赖领域作为一名独立调查员建立职业生涯：为女性开发和评估创新的戒烟干预措施。女性吸烟带来的健康风险甚至比男性更大，但现有的治疗方法更难戒烟。拟议的研究计划针对女性戒烟的主要障碍，对戒烟后体重增加的担忧，并涉及开发和初步评估一种基于痛苦耐受性的新型体重担忧治疗方法。利特文博士的培训和这项研究的实施将由一个导师团队监督，这些导师具有以下方面的专长：戒烟疗法的开发(主要导师理查德·布朗博士和共同导师克里斯托弗·卡勒博士)、痛苦耐受性(布朗博士)、临床试验方法(布朗博士、卡勒博士和共同导师雷纳·荣博士)、女性的身体形象和体重问题(共同导师J·凯文·汤普森博士和荣博士)，以及临床试验的纵向数据分析(卡勒博士)。利特文博士的培训目标将包括开发戒烟治疗和随机对照试验方法学方面的专业知识，精通随机对照试验的先进统计技术，获得有关女性身体形象和体重问题的基础知识，并加强她现有的手稿和拨款撰写技能。这些目标将通过参与由导师监督的直接研究和临床经验以及教学培训来实现。利特文博士将定期与所有导师见面，参加实验室和期刊俱乐部会议，为荣博士目前正在进行的一项试验担任研究治疗师，与导师合作撰写手稿，并接受有关耐受痛苦行为评估和治疗忠诚度评估的专门培训。教学内容包括导师布置的阅读材料、定性研究方法和随机对照试验方法的正式课程、纵向数据分析的密集工作坊和研讨会，以及出席会议。拟议的研究计划将分两个阶段进行。在第一阶段(1-2年)，将制定和试行基于群体的体重关注痛苦容忍治疗(DT-W)和基于对照群体的健康教育干预(HE)干预。所有试点参与者还将接受标准的戒烟治疗(ST)，包括集体行为咨询和尼古丁贴片。DT-W将使用迭代过程进行试验。将编写一份原型手册，并与最初的10名参与者一起进行测试；这些参与者将就可行性和可接受性提供反馈意见，以指导修改和完善DT-W，包括在治疗期间和治疗后个别访谈期间每周完成问卷调查。然后，将与第二组10名参与者重复这一进程，以最后确定DT-W议定书。高等教育干预将基于现有的方案，这些方案得到了充分的关注和欢迎；因此，高等教育将只由10名参与者组成的一个小组进行试点。在第二阶段(3-5年)，将对60名体重相关的女性吸烟者进行初步随机对照试验(RCT)，以比较最终的DT-W加ST和HE加ST。主要的吸烟结果将包括复发的潜伏期，在1，3和6个月的随访中戒烟，以及滞留。潜在的机制将被研究包括痛苦耐受性，戒烟的自我效能，体重和身体形象的关注，情感，以及对认知和情感触发的饮食反应。根据这项随机对照试验的结果，DT-W将进一步改进，利特文博士将开发并提交一份R01申请，以在更大规模的临床试验中评估DT-W的疗效。

DESCRIPTION (provided by applicant): The goal of this K23 Mentored Patient-Oriented Research Career Development Award is to provide the candidate, Dr. Erika Litvin, with the training necessary for her to establish a career as an independent investigator in an area of critical importance within tobacco dependence: the development and evaluation of innovative smoking cessation interventions for women. Women face even greater health risks from cigarette smoking than men, yet have more difficulty quitting with existing treatments. The proposed research plan targets a primary barrier to smoking cessation among women, concern about post-cessation weight gain, and involves the development and preliminary evaluation of a novel, distress tolerance-based treatment for weight concern. Dr. Litvin's training and execution of this research will be supervised by a team of mentors with expertise in treatment development for smoking cessation (primary mentor Dr. Richard Brown, co-mentor Dr. Christopher Kahler), distress tolerance (Dr. Brown), clinical trials methodology (Dr. Brown, Dr. Kahler, co- mentor Dr. Rena Wing), body image and weight concerns of women (co-mentor Dr. J. Kevin Thompson, Dr. Wing), and longitudinal data analysis for clinical trials (Dr. Kahler). Dr. Litvin's training goals will include developing expertise in treatment development for smoking cessation and randomized controlled trials methodology, becoming proficient in advanced statistical techniques for RCTs, acquiring a foundation of knowledge in body image and weight concerns of women, and strengthening her existing skills in manuscript and grant writing. These goals will be achieved through participation in direct research and clinical experiences supervised by mentors and didactic training. Dr. Litvin will meet regularly with all mentors, attend laboratory and journal club meetings, serve as a study therapist for one of Dr. Wing's current trials, collaborate with mentors on manuscripts, and receive specific training in behavioral assessment of distress tolerance and evaluation of treatment fidelity. Didactics will include readings assigned by mentors, formal coursework in qualitative research methods and RCTs methodology, intensive workshops and seminars in longitudinal data analysis, and attendance at conferences. The proposed research plan will be conducted in two phases. During the first phase (years 1-2), the group-based Distress Tolerance Treatment for Weight Concern (DT-W) and a comparison group-based Health Education (HE) intervention will be developed and piloted. All pilot participants will also receive standard smoking cessation treatment (ST), including group behavioral counseling and transdermal nicotine patch. DT-W will be piloted using an iterative process. A prototype manual will be developed and tested with an initial group of 10 participants; these participants will provide feedback on feasibility and acceptability to guide the modification and refinement of DT-W, including completion of questionnaires weekly during treatment and post-treatment individual interviews. This process will then be repeated with a second group of 10 participants to finalize the DT-W protocol. The HE intervention will be based on existing protocols that have been well-attended and well-received; therefore, HE will only be piloted with one group of 10 participants. During Phase 2 (years 3-5), a preliminary randomized controlled trial (RCT) will be conducted with 60 weight-concerned female smokers to compare the final DT-W plus ST to HE plus ST. Primary smoking outcomes will include latency to relapse, abstinence at 1, 3-, and 6-month follow-ups, and retention. Potential mechanisms to be examined will include distress tolerance, self-efficacy for smoking cessation, weight and body image concern, affect, and eating in response to cognitive and affective triggers. Based on the outcomes of this RCT, DT-W will be further refined and Dr. Litvin will develop and submit an R01 application to evaluate the efficacy of DT-W in a larger scale clinical trial.