Effectiveness of Cognitive Behavioral Therapy compared with Basic health education for tobacco cessation among 35-44 years smoker drivers at Government Bus stand, Patna: A randomized control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Tobacco abstinence confirmed through a combination of self-reported cessation through TTM Questionnaire and objective validation using exhaled carbon monoxide (CO) levels measured by the Bedfont R Scientific EC50 Micro-III Smoke analyzer.
研究概览
简要总结
This is a single blind two arm randomized controlled trial designed to evaluate the effectiveness of CBT compared with BHE for tobacco cessation among government bus drivers aged 35-44 years at government bus stand, patna. A total of 200 participants 100 in each group will be randomly allocated using simple randomization. The primary outcome will be tobacco abstinence confirmed by self report and exhaled CO levels. Secondary outcomes will be seen using transtheoretical model based questionnaire. Follow up will be conducted at 4 and 12 weeks.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 35.00 Year(s) 至 44.00 Year(s)（—）
- 性别
- Male
入选标准
- •Participants who remained current smokers , who respond to the questionnaire and give consent will be enrolled.
排除标准
- •Participant who uses smokeless form of tobacco Previous history of alcohol and/or illegitimate drug abuse in the past 12 months Participants who received tobacco cessation counseling previously.
- •Participants under nicotine replacement therapy (NRT) Participants who will not give consent or are uncooperative.
结局指标
主要结局
Tobacco abstinence confirmed through a combination of self-reported cessation through TTM Questionnaire and objective validation using exhaled carbon monoxide (CO) levels measured by the Bedfont R Scientific EC50 Micro-III Smoke analyzer.
时间窗: Baseline, 4 weeks, and 12 weeks post-intervention.
次要结局
- Change in nicotine dependence levels as measured by the Fagerström Test for Nicotine Dependence (FTND) score.(Baseline, 4 weeks, and 12 weeks post-intervention.)
- Stage progression in the Transtheoretical Model (TTM) – e.g., from pre-contemplation to maintenance.(Baseline, 4 weeks, and 12 weeks post-intervention.)
- Improvement in self-efficacy and reduction in temptation to smoke, assessed using validated TTM scales.(Baseline, 4 weeks, and 12 weeks post-intervention.)
- Change in decisional balance scores (pros vs. cons of smoking).(Baseline, 4 weeks, and 12 weeks post-intervention.)
研究者
Dr Gagan Raj
Teerthanker Mahaveer Dental college and Research Centre