Tobacco dependence counseling in a randomized multisite clinical trial
Tobacco dependence counseling in a randomized multisite clinical trial
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DOI：
10.1016/j.cct.2012.02.014
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发表时间：
2012-07-01
影响因子：
2.2
通讯作者：
Hurt, Richard D.
中科院分区：
文献类型：
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作者：
Croghan, Ivana T.;Trautman, Judith A.;Hurt, Richard D.
治疗烟草依赖的药物治疗试验将受益于行为干预，提供符合临床实践指南的治疗，但不指导参与者接受试验中未评估的治疗。无烟和生活（C）行为干预手册包括参与者和干预者指南，旨在提供实用的咨询和治疗期间的支持。我们在一项多中心、随机的吸烟者注意缺陷多动障碍的临床试验中使用了这本干预手册。在这项研究中，我们评估了如何在“培训师培训”模型中进行干预手册，需要在6个站点和15名干预人员之间进行统一咨询。我们分析了干预者的技能依从性和参与者的干预依从性。255名随机化受试者完成了9.3 +/- 2.8个疗程（平均值+/- SD），157名受试者（61.6%）完成了所有11个疗程，221名受试者（86.7%）完成了11个疗程中的至少6个疗程。在对研究介入医生进行评价的163次会议中，156次（95.7%）被评为遵守方案，并在7项既定标准中至少有6项标准上“符合预期”，这表明可以在最低限度的监督下保持保真度。因此，《无烟生活手册》中的自助和干预者指南可用于提供行为干预，干预者和参与者的依从率都很高。本手册符合美国公共卫生服务临床实践指南的要求，可适用于特定的研究方案，并为戒烟临床试验期间的行为干预提供了有用的选择。(C)2012 Elsevier Inc. All rights reserved.
Pharmacotherapy trials for treating tobacco dependence would benefit from behavioral interventions providing treatment consistent with clinical practice guidelines but not directing participants to treatments not evaluated in the trial. The Smoke Free and Living It(C) behavioral intervention manual includes participant and interventionist guides and is designed to provide both practical counseling and intra-treatment support. We utilized this intervention manual in a multicenter, randomized clinical trial of smokers with attention deficit hyperactivity disorder. In this study, we evaluated how the interventional manual performed in a "train-the-trainer" model requiring uniform counseling across 6 sites and 15 interventionists. We analyzed the skill-adherence of the interventionists and the intervention-adherence of the participants. The 255 randomized participants completed 9.3 +/- 2.8 sessions (mean +/- SD), with 157 participants (61.6%) completing all 11 of the sessions and 221 (86.7%) completing at least 6 of the 11 sessions. Of the 163 sessions for which the study interventionists were evaluated, 156 (95.7%) were rated as adherent to protocol and "meeting expectations" on at least 6 of 7 established criteria, illustrating that fidelity can be maintained with minimal supervision. The self-help and interventionists guides of the Smoke Free and Living It manual can thus be used to provide behavioral intervention with a high rate of adherence by both the interventionists and the participants. This manual meets the requirements of the United States Public Health Service Clinical Practice Guideline, can be adapted to specific research protocols, and provides a useful option for behavioral intervention during clinical trials for smoking cessation. (C) 2012 Elsevier Inc. All rights reserved.