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.
Concern about post-cessation weight gain is a significant barrier to smoking cessation among women. In this project, a novel distress tolerance-based treatment for weight-concerned female smokers will be developed and evaluated in a preliminary randomized controlled trial, in preparation for future testing in a larger clinical tril and adaption of this approach into more readily disseminable formats. If successful, the development and subsequent dissemination of this treatment approach will have important clinical and public health significance in decreasing the overall prevalence of cigarette smoking among women, thereby reducing smoking-related morbidity and mortality.