Distress Tolerance Treatment for Weight Concern in Smoking Cessation Among Women

描述（由申请人提供）：该K23指导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的一个至关重要的领域作为独立调查员建立职业生涯：开发和评估创新的女性戒烟干预措施。女性吸烟比男性面临更大的健康风险，但用现有的治疗方法戒烟更困难。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新的基于痛苦耐受的体重治疗方法。Litvin博士的培训和这项研究的执行将由一个具有戒烟治疗开发专业知识的导师团队监督（主要导师理查德·布朗博士，共同导师克里斯托弗·卡勒博士），痛苦容忍（Dr. Brown），临床试验方法学（布朗博士，卡勒博士，共同导师雷纳翼博士），身体形象和体重的妇女的关注（共同导师J. Kevin Thompson博士，Wing博士），以及临床试验纵向数据分析（Kahler博士）。Litvin博士的培训目标将包括发展戒烟治疗开发和随机对照试验方法的专业知识，精通RCT的先进统计技术，获得女性身体形象和体重问题的知识基础，并加强她现有的手稿和赠款写作技能。这些目标将通过参与导师和教学培训监督的直接研究和临床经验来实现。Litvin博士将定期与所有导师会面，参加实验室和期刊俱乐部会议，担任Wing博士当前试验之一的研究治疗师，与导师合作撰写手稿，并接受痛苦耐受力行为评估和治疗保真度评估的特定培训。教学将包括导师指定的阅读，定性研究方法和RCT方法的正式课程，纵向数据分析的密集讲习班和研讨会，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），将开发和试点基于组的体重问题痛苦耐受治疗（DT-W）和基于对照组的健康教育（HE）干预。所有试点参与者还将接受标准戒烟治疗（ST），包括团体行为咨询和透皮尼古丁贴片。DT-W将使用迭代过程进行试点。将开发一个原型手册，并在最初的10名参与者中进行测试;这些参与者将提供关于可行性和可接受性的反馈，以指导DT-W的修改和完善，包括在治疗期间每周完成问卷调查和治疗后的个人访谈。然后，第二组10名参与者将重复这一过程，以最终确定DT-W方案。HE干预将基于现有的方案，这些方案已经得到了广泛的参与和好评;因此，HE将只在一组10名参与者中进行试点。在第2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DT-W加ST与HE加ST。主要吸烟结局将包括复发潜伏期，1、3和6个月随访时的戒烟率和保留率。待检查的潜在机制将包括痛苦耐受性，戒烟的自我效能，体重和身体形象的关注，影响，以及对认知和情感触发的饮食反应。根据这项RCT的结果，DT-W将进一步完善，Litvin博士将开发并提交R 01申请，以评估DT-W在更大规模临床试验中的疗效。

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.