López-Núñez Carla, Fernández-Artamendi Sergio, Ruiz-Aranda Desirée, Resurrección Davinia María, Navas-Campaña Desirée
Department of Personality, Assessment and Psychological Treatments, School of Psychology, University of Seville, Seville (Andalusia), Spain.
Department of Psychology, Universidad Loyola Andalucía, Seville (Andalusia), Spain.
Contemp Clin Trials Commun. 2024 Aug 28;41:101361. doi: 10.1016/j.conctc.2024.101361. eCollection 2024 Oct.
Tobacco use represents a significant public health burden, being especially harmful for smokers with Type 2 Diabetes Mellitus (T2DM). Effective smoking cessation interventions are required for this vulnerable population. The goal is to describe a study protocol of a randomized controlled trial (RCT) aimed at analyzing the effectiveness and efficiency of a multicomponent smoking cessation intervention for T2DM smokers, including a training protocol on healthy lifestyle habits and self-management of T2DM ( project).
This RCT will assign participants to: (1) Control Group (n = 30), including a brief psychoeducation advice about smoking cessation; (2) Cognitive-behavioral treatment (CBT) for smoking cessation (n = 30), based on a multicomponent program implemented in group-based sessions over an eight-week period; and (3) CBT plus protocol (n = 30), which will develop an additional psychoeducational protocol specifically designed to improve healthy lifestyle habits. Participants will be assessed at baseline, post-treatment and several follow-ups (1-, 6- and 12-months). Primary outcomes will include smoking abstinence (24-h point prevalence abstinence at post-treatment and 7-day point prevalence at follow-ups) and smoking continuous abstinence. Secondary outcomes will include treatment retention, changes in smoking patterns and nicotine dependence, as well as the impact on T2DM clinical variables, mental health, and quality of life.
The program could assist T2DM smokers in quitting tobacco use and improving their overall quality of life. This project will help incorporating improvements in routine clinical practice with T2DM patients, offering a smoking cessation program adapted to their specific needs.
ClinicalTrials.gov. Identifier: NCT05885659. Date of registration: June 2nd, 2023.
烟草使用是一项重大的公共卫生负担，对2型糖尿病（T2DM）吸烟者尤其有害。这一弱势群体需要有效的戒烟干预措施。目标是描述一项随机对照试验（RCT）的研究方案，旨在分析针对T2DM吸烟者的多成分戒烟干预措施的有效性和效率，包括关于健康生活习惯和T2DM自我管理的培训方案（项目）。
该RCT将把参与者分为：（1）对照组（n = 30），包括关于戒烟的简短心理教育建议；（2）戒烟的认知行为疗法（CBT）组（n = 30），基于在为期八周的小组会议中实施的多成分方案；以及（3）CBT加 方案组（n = 30），该组将制定一项专门设计用于改善健康生活习惯的额外心理教育方案。将在基线、治疗后和几次随访（1个月、6个月和12个月）时对参与者进行评估。主要结果将包括戒烟（治疗后24小时点患病率戒烟和随访时7天点患病率戒烟）和持续戒烟。次要结果将包括治疗保留率、吸烟模式和尼古丁依赖的变化，以及对T2DM临床变量、心理健康和生活质量的影响。
方案可以帮助T2DM吸烟者戒烟并改善他们的整体生活质量。该项目将有助于将针对T2DM患者的常规临床实践改进纳入其中，提供一个适应他们特定需求的戒烟方案。
ClinicalTrials.gov。标识符：NCT05885659。注册日期：2023年6月2日。
