Adjunctive Mood Management for Telephone-based Smoking Cessation in Primary Care

 描述(由申请人提供)： 吸烟是可预防的死亡的唯一最大原因。在退伍军人保健系统中，慢性病患者是戒烟努力重点关注的重要人群。在患有慢性内科疾病的患者中戒烟可以大大降低发病率和死亡率。尽管有这些好处，许多患有慢性病的患者仍在继续吸烟。抑郁症和慢性疾病之间有很强的相互关系。抑郁症可能会破坏持续的戒烟，并可能成为患有慢性疾病的退伍军人戒烟的重要障碍。尽管面临障碍，患有抑郁症的吸烟者仍有戒烟的动力。有抑郁病史的吸烟者可能会对戒烟干预措施做出更好的反应，戒烟干预加上情绪管理辅助工具，如情绪管理咨询。因此，当行为情绪管理被添加到传统的戒烟方法中时，抑郁的吸烟者更有可能戒烟。然而，通过行为情绪管理来加强戒烟还没有得到确凿的证实。此外，这些密集的干预措施在亲自进行时影响有限。电话咨询可以为吸烟者提供密集而有效的治疗，但在患有抑郁症的吸烟者中实施有限。需要开发新的主动电话传递的方法，可以广泛地向可能对标准护理无效的退伍军人提供强化戒烟干预，例如那些患有慢性病和抑郁症状的退伍军人。这项研究的具体目的是：1)评估电话传递的戒烟干预加上行为情绪管理对患有慢性内科疾病和抑郁症的退伍军人长期戒烟率和时点戒烟率的影响；2)监测行为情绪管理干预对抑郁症状的影响；3)如果有效，评估自我效能感、积极和消极情绪以及戒烟动机的变化是否中介了戒烟的影响 退伍军人戒烟行为情绪管理干预；4)评估情绪强化干预的成本-效果。建议进行一项两组设计的随机比较有效性试验，将350名患有抑郁症和慢性疾病的资深吸烟者随机分为以下两组：1)戒烟加辅助性行为情绪管理(SMK-MM组)，这是一种积极主动的远程健康干预措施，将循证戒烟咨询与行为情绪管理相结合，并提供远程医学诊所，以获得尼古丁替代疗法(NRT)；或2)戒烟电话咨询对照组(SMK对照)，提供同样的戒烟电话咨询干预并辅之以健康教育(而不是情绪管理)和用于获得NRT的远程医学诊所。患有慢性疾病的患者将从达勒姆退伍军人事务医院的患者吸入系统中识别出来，并对吸烟和抑郁症状进行筛查。这项试验的主要结果是在6个月和12个月的随访中长期禁欲。Logistic回归将被用来检验在6个月时自我报告长期戒烟的患者所占比例的组间差异。一般的线性混合模型将被用来估计组之间抑郁症状的变化。如果对戒烟有显著的干预效果，将进行冥想分析，以检验自我效能感、情感和戒烟动机的变化是否中介了情绪管理干预的影响。

 DESCRIPTION (provided by applicant): Cigarette smoking is the single greatest cause of preventable deaths. In the VA health care system, patients with chronic medical illnesses represent an important population on which to focus smoking cessation efforts. Smoking cessation among patients with chronic medical illnesses can substantially decrease morbidity and mortality. Despite these benefits, many patients with chronic medical illnesses continue to smoke. There is a strong interrelationship between depression and chronic medical illness. Depression can derail sustained smoking cessation and may be an important barrier to smoking cessation for Veterans with chronic medical illness. Despite the barriers they face, smokers with depression are motivated to quit smoking. Smokers with histories of depression may respond better to smoking cessation interventions that are augmented with mood- management adjuncts such as mood-management counseling. Thus, depressed smokers are more likely to quit when behavioral mood-management is added to traditional cessation approaches. Yet, the augmentation of smoking cessation with behavioral mood management is not yet firmly established. Also these intensive interventions have limited reach when conducted in person. Telephone counseling can deliver intensive and effective treatment to people who smoke, yet its implementation has been limited among smoker with depression. There is a need to develop novel proactive telephone-delivered approaches that can broadly deliver intensive smoking cessation interventions to Veterans who may not respond to standard care, such as those with chronic medical illnesses and depressive symptoms. The specific aims of the study are to 1) evaluate the impact of a telephone-delivered smoking cessation intervention augmented with behavioral mood management on rates of prolonged and point prevalence abstinence from cigarettes among Veterans with chronic medical illnesses and depression; 2) monitor the impact of behavioral mood management intervention on depressive symptoms; 3) if effective, assess whether change in self-efficacy, positive and negative affect, and motivation to quit mediate the impact of behavioral mood management intervention on smoking cessation among Veterans; and 4) assess the cost-effectiveness if the mood-enhanced intervention. Proposed is a randomized comparative effectiveness trial with a two-group design in which 350 Veteran smokers with depression and chronic medical illness will be randomized to either: 1) smoking cessation plus adjunctive behavioral mood management (SMK-MM group), an intervention that includes a proactive tele- health intervention that combines evidence-based smoking cessation counseling augmented with behavioral mood management and a tele-medicine clinic for accessing nicotine replacement therapy (NRT), or 2) smoking cessation telephone counseling control (SMK CONTROL), a contact-equivalent control that provides the same smoking cessation telephone counseling intervention augmented with health education (instead of mood management) and a tele-medicine clinic for accessing NRT. Patients with chronic medical illnesses will be identified from patient intake systems of the Durham Veteran's Affairs Hospital and screened for tobacco use and depressive symptoms. The main outcome in this trial is prolonged abstinence at 6-month and 12-month follow-up. Logistic regression will be used to test for a between-group difference in the proportion of patients with self-reported prolonged abstinence from cigarettes at 6 months. A general linear mixed model will be used to estimate changes depressive symptoms between groups. If there is a significant intervention effect on smoking cessation, meditational analysis will be conducted to examine whether changes in self-efficacy, affect, and motivation to quit mediate the impact of the mood management intervention.