Pain-related Anxiety Invervention for Smokers with Chronic Pain: A Comparative Effectiveness Trial of Smoking Cessation Counseling for Veterans

影响：吸烟是美国军队中可预防的死亡的最大原因。 吸烟的危险因素和大约20%的美国退伍军人是吸烟者。疼痛经常被报告为 退伍军人和研究表明，吸烟与同时存在的疼痛强度有关。患有慢性病的退伍军人 疼痛代表着一个重要的人群，在他们中，戒烟努力是重点。 背景：慢性内科疾病患者戒烟显著减少 发病率和死亡率；然而，许多患有慢性疼痛的患者(50%)继续吸烟。最近，胡腾等人 测试使用认知行为干预(CBI)强化的标准戒烟方案 针对慢性阻塞性肺疾病住院患者情绪困扰的针对性应对策略 疼痛。结果显示，接受CBI治疗的患者中有20%的人戒烟，而 对照组随访6个月时无一例发生。伴随着解决戒烟问题的努力和 通过已建立的CBIS，疼痛相关焦虑有可能为吸烟者提供必要的疼痛技能 引导戒烟过程并管理与焦虑相关的干扰因素 戒烟的努力。鉴于吸烟的广泛流行及其对退伍军人健康的惊人影响，VHA 强调了采取公共卫生方法戒烟的必要性。从公共卫生角度来看 从角度来看，影响定义为覆盖范围(即，获得/接受干预的退伍军人数量) 乘以有效性(干预的效果大小)。努力扩大戒烟工作的覆盖面 虽然同时消除限制获得和参与有效干预的障碍是至关重要的 在人口层面上提高戒毒率。目前的调查结合了既定的 CBI的有效性和主动电话干预的覆盖范围。这项研究旨在测试 为患有慢性疼痛的资深吸烟者提供CBI戒烟电话。 目的：目的1：评估戒烟加CBI(SMK-CBI)对戒烟的影响 6个月和12个月有慢性疼痛的退伍军人中的比率。 假设1.1和1.2：长期禁酒率(H 1.1)和7天点戒毒率 在接受SMK-CBI治疗的患有慢性疼痛的退伍军人中，(h 1.2)将显著高于 2)戒烟电话咨询对照组(SMK对照组)。 目的2：评价SMK-CBI对6岁和12岁退伍军人的疼痛强度和疼痛干扰的影响。 月份。 假设2.1：SMK-CBI的退伍军人报告通常疼痛强度和疼痛干扰显著降低 相对于SMK控件。 目的3：评估自我效能感和疼痛相关焦虑的变化是否中介SMK-CBI对 在6个月和12个月有疼痛的退伍军人中戒烟。 假设3.1：SMK-CBI与报告戒烟之间的关系将由自我调节 有效性和疼痛相关焦虑。此外，教授这些技能将改善疼痛相关焦虑。 方法：采用两组设计的随机对照有效性试验，共370 患有慢性疼痛的资深吸烟者将被随机分为以下两组：1)SMK-CBI，一种包括 积极主动的远程健康干预结合循证戒烟咨询 应对疼痛的行为方法和获得尼古丁替代品的远程医疗诊所 疗法(NRT)，或2)SMK对照，一种提供标准戒烟服务的接触性等效对照 电话咨询和远程医疗诊所接入NRT。

Impacts: Cigarette smoking is the single greatest cause of preventable deaths in the U.S. Military service is a risk factor for smoking and approximately 20% of US Veterans are smokers. Pain is frequently reported by Veterans and research suggests smoking is associated with concurrent pain intensity. Veterans with chronic pain represent an important population in which to focus smoking cessation efforts. Background: Smoking cessation among patients with chronic medical illnesses substantially decreases morbidity and mortality; yet, many patients (>50%) with chronic pain continue to smoke. Recently, Hooten et al tested a standard smoking cessation protocol augmented with a cognitive behavioral intervention (CBI) targeting coping strategies for emotional distress to address smoking among hospitalized patients with chronic pain. Results revealed that 20% of the patients in the CBI condition were abstinent from smoking compared to none in the control group at the 6 month follow-up. Concomitant efforts to address smoking cessation and pain-related anxiety, via established CBIs, have the potential to provide smokers with pain the requisite skills to navigate the smoking cessation process and manage the associated anxiety-related cues that interfere with efforts to quit. Given the widespread prevalence of smoking and its staggering impact on Veteran health, VHA has highlighted the need for adopting a public health approach to smoking cessation. From a public health perspective, the impact is defined as Reach (i.e., number of Veterans who access/receive an intervention) multiplied by Efficacy (effect size of an intervention). Efforts to improve the reach of smoking cessation efforts while simultaneously removing barriers that limit access to and participation in effective interventions is critical to improving cessation rates at the population level. The current investigation combines the established efficacy of a CBI and the reach of a proactive telephone-delivered intervention. This study aims to test the telephone delivery of a CBI, for smoking cessation among Veteran smokers with chronic pain. Objectives: AIM 1: Evaluate the impact of smoking cessation plus CBI (SMK-CBI) on cigarette abstinence rates among Veterans with chronic pain at 6 and 12-months. Hypotheses 1.1 & 1.2: Prolonged abstinence rates (H 1.1) and 7-day point prevalence abstinence rates (H 1.2) will be significantly higher among Veterans with chronic pain who receive SMK-CBI compared with those in 2) smoking cessation telephone counseling control (SMK Control). AIM 2: Evaluate the impact of SMK-CBI on pain intensity and pain interference among Veterans at 6- and12- months. Hypothesis 2.1: Veterans in SMK-CBI will report significantly lower usual pain intensity and pain interference relative to SMK Control. AIM 3: Assess whether change in self-efficacy and pain-related anxiety mediate the impact of SMK-CBI on smoking cessation in Veterans with pain at 6- and 12-months. Hypothesis 3.1: The relationship between SMK-CBI and reported smoking cessation will be mediated by self- efficacy and pain-related anxiety.In addition, teaching these skills will improve pain-related anxiety. Methods: Proposed is a randomized comparative effectiveness trial with a two-group design in which 370 Veteran smokers with chronic pain will be randomized to either: 1) SMK-CBI, an intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain and a tele-medicine clinic for accessing nicotine replacement therapy (NRT), or 2) SMK Control, a contact-equivalent control that provides standard smoking cessation telephone counseling and a tele-medicine clinic for accessing NRT.