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

 描述（由申请人提供）： 吸烟是可预防死亡的最大单一原因。在VA医疗保健系统中，慢性疾病患者是戒烟工作的重点人群。慢性疾病患者戒烟可以大大降低发病率和死亡率。尽管有这些好处，许多患有慢性疾病的患者继续吸烟。抑郁症和慢性疾病之间有很强的相互关系。抑郁症可以破坏持续戒烟，可能是患有慢性疾病的退伍军人戒烟的重要障碍。尽管他们面临的障碍，吸烟者与抑郁症的动机戒烟。有抑郁症史的吸烟者可能对戒烟干预反应更好，这些干预措施与情绪管理咨询等情绪管理措施相结合。因此，当行为情绪管理被添加到传统的戒烟方法时，抑郁的吸烟者更有可能戒烟。然而，行为情绪管理对戒烟的增强作用尚未确立。此外，这些密集干预措施在亲自进行时覆盖面有限。电话咨询可以为吸烟者提供密集有效的治疗，但其实施仅限于吸烟者抑郁症。有必要开发新的主动电话提供的方法，可以广泛地提供密集的戒烟干预退伍军人谁可能不响应标准护理，如慢性疾病和抑郁症状。 本研究的具体目的是：1）评估电话戒烟干预与行为情绪管理对患有慢性疾病和抑郁症的退伍军人长期戒烟率和点戒烟率的影响; 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、积极和消极影响以及戒烟动机的变化是否介导了 行为情绪管理干预对退伍军人戒烟的影响; 4）评估情绪增强干预的成本效益。 拟定的是一项随机比较有效性试验，采用两组设计，其中350名患有抑郁症和慢性疾病的退伍军人吸烟者将被随机分配至：1）戒烟加辅助行为情绪管理（SMK-MM组），一种干预措施，包括积极的远程健康干预，结合基于证据的戒烟咨询，加强行为情绪管理和远程，用于获得尼古丁替代治疗（NRT）的医学诊所，或2）戒烟电话咨询控制（SMK CONTROL），一种提供相同的戒烟电话咨询干预并增加健康教育（而不是情绪管理）的接触等效控制，以及用于获得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入院系统中确定，并进行烟草使用和抑郁症状的筛查。 本试验的主要结局是6个月和12个月随访时的长期禁欲。将使用逻辑回归来检验6个月时自我报告长期戒烟的患者比例的组间差异。一般线性混合模型将用于估计组间抑郁症状的变化。如果对戒烟有显著的干预效果，将进行冥想分析，以检查自我效能、情感和戒烟动机的变化是否介导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.