Pain-related Anxiety Intervention for Smokers With Chronic Pain: A Comparative Effectiveness Trial of Smoking Cessation Counseling for Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 371
- 试验地点
- 4
- 主要终点
- Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence)
研究概览
简要总结
This purpose of this study is to test the telephone delivery of a cognitive behavioral intervention (CBI), for smoking cessation among Veteran smokers with chronic pain
详细描述
Veterans with chronic pain represent an important population in which to focus smoking cessation efforts. Smoking cessation among patients with chronic medical illnesses substantially decreases morbidity and mortality; yet, many patients (>50%) with chronic pain continue to smoke.
This study aims to test the telephone delivery of a cognitive behavioral intervention (CBI), for smoking cessation among Veteran smokers with chronic pain. Proposed is a randomized comparative effectiveness trial with a two-group design in which 370 Veteran smokers with chronic pain will be randomized to either: 1) smoking cessation plus CBI (SMK-CBI), an intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain 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 standard smoking cessation telephone counseling and a tele-medicine clinic for accessing NRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans enrolled at VA Connecticut or VA Central Western Massachusetts
- •Current Cigarette Smokers
- •Willing to make quit attempt in next 30 days
- •Pain intensity 4 or greater on scale 0-10, self-reported
排除标准
- •Non-English speaking
- •No access to telephone/Lack of Telephone Access
- •Severely impaired hearing
- •Active diagnosis
- •Terminal Illness
- •Refusal to provide informed consent
- •Enrolled in concurrent smoking cessation programs/research
结局指标
主要结局
Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence)
时间窗: 12-month post intervention
In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?
Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence)
时间窗: 6-month post intervention
30-day point prevalence abstinence rates, Have he/she smoked at least part of a cigarette in last 30 days?
Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence)
时间窗: 12 month post intervention
30-day point prevalence abstinence rates, have he/she smoked at least part of a cigarette in last 30 days?
Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence)
时间窗: 6-month
In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?
次要结局
- Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months(Baseline to 6-month post intervention)
- Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months(Baseline to 12-month post-intervention)
- Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months(Baseline to 6-month post intervention)
- Change in Pain Interference, Difference Between Baseline and Interference(Baseline to 12-month post intervention)