Stage II Trial of Novel Behavioral Activation Intervention for Smoking Cessation

新型戒烟行为激活干预措施的第二阶段试验

• 批准号: 8207437
• 负责人: Laura MacPherson
• 金额: $ 3.78万
• 依托单位: UNIV OF MARYLAND, COLLEGE PARK
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8207437
• 关键词: Abstinence; Accounting; Anxiety Disorders; Attention; Behavior Therapy; Behavioral; Brain region; Cause of Death; Centers for Disease Control and Prevention (U.S.); Cessation of life; Clinical; Cognitive; Cognitive Therapy; Collaborations; Communities; Complex; Conduct Clinical Trials; Development; Event; Failure; Functional Magnetic Resonance Imaging; Funding; Goals; Grant; Health; Individual; Intervention; Investigation; Knowledge; Low income; Major Depressive Disorder; Manuals; Maryland; Mediating; Mental Depression; Methodology; Minority; Mood Disorders; Moods; National Institute of Drug Abuse; National Institute of Mental Health; Outcome; Participant; Patients; Prevalence; Protocols documentation; Psychological reinforcement; Public Health; Randomized; Randomized Controlled Trials; Recording of previous events; Recruitment Activity; Relapse; Relative (related person); Research; Resources; Rewards; Risk; Sample Size; Sampling; Smoke; Smoker; Smoking; Smoking Behavior; Smoking Cessation Intervention; Specific qualifier value; Staging; Testing; Time; United States; Universities; Withholding Treatment; Work; abstracting; base; behavior measurement; cigarette smoking; depressive symptoms; disability; follow-up; improved; innovation; meetings; neurobehavioral; nicotine patch; novel; novel strategies; programs; randomized trial; response; smoking cessation; smoking relapse; success; theories; therapy development; treatment effect; trial comparing

Abstract Cigarette smoking is the leading cause of death and disability in the United States. Moreover, depression- related vulnerabilities are highly comorbid with smoking behavior and dramatically reduce cessation rates among both community and clinical samples. Previous research has examined the efficacy of integrating cognitive-behavioral treatment for depression into standard smoking cessation treatment focusing on individuals who have a past history of major depressive disorder (MDD). However, success has been limited in focusing on MDD history. A broader health impact can be achieved by targeting individuals with current elevated depressive symptoms given their association with cessation failure. Furthermore, the complexity of cognitive behavioral approaches for depression may impair their effective integration into smoking cessation protocols. As a result, new approaches to smoking cessation are needed for smokers with currently elevated depressive symptoms. We have recently completed an initial randomized controlled trial comparing an integrated novel behavioral activation smoking cessation treatment (BATS) versus standard smoking cessation treatment (ST) [with both conditions receiving 8 weeks of transdermal nicotine patch (TNP)] among smokers with elevated depressive symptoms. Preliminary findings indicate that in the first week post quit date, participants receiving BATS (n = 26) were 2.7 times more likely to be abstinent (p < .05) than ST (n = 16) participants. BATS participants also evidenced significantly higher (p = .02) abstinence rates than ST participants throughout the 26 week post-quit follow-up period. Preliminary results are encouraging and support a larger Stage II randomized controlled trial in order to better establish BATS as an efficacious treatment for smokers with depression-relevant vulnerabilities. Of further relevance, participants in this study were predominantly low income, minority individuals. This is important given considerable documented barriers to cessation and lower cessation rates for this at-risk group. Thus, the objective of the present proposal is to follow-up on our previous Stage I treatment development efforts and small scale randomized controlled trial (RCT) with a Stage II RCT comparing BATS to ST among a similar sample of 200 predominantly low income and minority smokers with elevated depressive symptoms. Treatments will be equated for participant and therapist contact time. Participants will be followed over 52 weeks post-quit date and the larger sample size will allow for more complex analyses of the mechanisms underlying cessation outcomes. We expect that as a result of this project, we will have provided evidence for the efficacy of a well-specified, novel behavioral activation smoking treatment that works well with smokers at significant risk for relapse.

摘要 在美国，吸烟是导致死亡和残疾的主要原因。此外，抑郁症- 相关脆弱性与吸烟行为高度共病，并显著降低戒烟率 在社区和临床样本中。以前的研究已经检查了整合的有效性 将抑郁症的认知行为治疗纳入标准戒烟治疗， 有重度抑郁症（MDD）病史的人。然而，成功是有限的， 专注于MDD历史。更广泛的健康影响可以通过针对目前患有 与戒烟失败有关的抑郁症状增加。此外， 抑郁症的认知行为方法可能会损害他们有效地融入戒烟 协议.因此，对于目前吸烟率升高的吸烟者来说，需要新的戒烟方法。 抑郁症状我们最近完成了一项初步的随机对照试验， 综合新型行为激活戒烟治疗（BATS）与标准戒烟 吸烟者接受治疗（ST）[两种情况均接受8周尼古丁透皮贴剂（TNP）] 抑郁症状加重初步调查结果表明，在戒烟后的第一周， 接受BATS的参与者（n = 26）的禁欲可能性是ST（n = 16）的2.7倍（p <0.05） 参与者BATS参与者的禁欲率也明显高于ST（p = 0.02） 参与者在戒烟后26周的随访期间。初步结果令人鼓舞， 支持更大规模的II期随机对照试验，以更好地确定BATS作为一种有效的 治疗有抑郁症相关脆弱性的吸烟者。更重要的是，这项研究的参与者 主要是低收入的少数民族。这一点很重要，因为有相当多的记录障碍 戒烟和降低戒烟率的风险。因此，本提案的目的是 对我们之前的I期治疗开发工作和小规模随机对照试验的随访 (RCT)第二阶段随机对照试验在200名主要是低收入者的类似样本中比较了BATS和ST 和少数吸烟者抑郁症状加重。受试者的治疗将等同， 治疗师联系时间参与者将在戒烟后52周内接受随访，较大的样本量将 允许对戒烟结果背后的机制进行更复杂的分析。我们希望，作为一个 这个项目的结果，我们将提供证据的有效性，一个明确的，新的行为 活化吸烟治疗，对有显著复发风险的吸烟者效果良好。