Enhancing an Intervention for Smokers With Chronic Pain Using IVR: A Randomized Clinical Trial of Smoking Cessation Counseling for Veterans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Cigarette Smoking Abstinence Rates
研究概览
简要总结
PASS2 aims to expand upon the recently completed study (PASS intervention), which tested the telephone delivery of a cognitive behavioral intervention (CBI). This study will use nightly surveys to optimize the intervention's effectiveness 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:
- Determine whether the existing integrated pain and smoking cessation (PASS intervention) augmented with nightly surveys (PASS2) is superior to treatment as usual (e.g., referral to standard VA smoking cessation clinic) enhanced with pharmacotherapy tele-consult (E-TAU) at 4 months and 10 months (primary endpoint) on cigarette abstinence rates among non-depressed Veterans with chronic pain.
- Determine whether PASS2 is superior to E-TAU at 4 months and 10 months (primary endpoint) on pain interference.
- Examine critical components of the intervention process to inform future program implementation.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 单盲 (结局评估者)
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
- being an enrolled Veteran at VACHS
- current tobacco use
- willingness to make a quit attempt
- significant chronic pain defined as >/=4 on the pain intensity portion of the Brief Pain Inventory (BPI) for more than 90 days
排除标准
- active diagnosis of dementia or psychosis in medical record
- severely impaired hearing or speech
- lack of telephone access
- enrollment in concurrent research study that might affect main outcomes of this study
- terminal illness
- non-English speaking
- pregnancy
- provider advising against exercise
- planned surgeries
- clinically significant depressive symptoms (>10 PHQ-9)
研究组 & 干预措施
Treatment as Usual
Treatment as usual includes referral to the local smoking cessation clinic where Veterans may select a virtual individual or group based cognitive behavioral smoking cessation program with a trained psychology intern, postdoctoral fellow or staff psychologist. In conjunction, Veterans are encouraged but not required, by clinic staff, to connect with the VA Quitline and the VA's Annie text-messaging service to support their quit. Veterans are strongly encouraged to consider pharmacotherapy (e.g., NRT patches and one of two rescue methods such as nicotine lozenge or gum or varenicline). The NRT dose and delivery route will be tailored to the number of cigarettes smoked per day (using an established protocol - interested Veterans will be offered a telemedicine consult for this service
干预措施: Treatment as Usual (Other)
PASS2
An intervention that includes a proactive telehealth intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain, and nightly surveys. Veterans in PASS2 will also be offered 12-weeks of pharmacotherapy (e.g., NRT patches and one of two rescue methods such as nicotine lozenge or gum or varenicline) via telemedicine consult. The NRT dose and delivery route will be tailored to the number of cigarettes smoked per day (using an established protocol).
干预措施: PASS2 (Behavioral)
结局指标
主要结局
Cigarette Smoking Abstinence Rates
时间窗: 10-month follow-up
In keeping with the sinus node recovery time (SNRT) recommendations for measuring abstinence, the investigators will use prolonged abstinence as our main outcome. During the 10-month follow-ups, patients will be asked about prolonged abstinence, "In the past 6 months, have you smoked a cigarette, even a puff?"
次要结局
- Cigarette Smoking Abstinence Rates(4-month follow up)
- Point prevalent abstinence(4-month and 10-month follow-up)
- Pain intensity and pain-related functional interference(4-month and 10-month follow-up)
研究者
研究点 (2)
标识符
- NCT 编号
- NCT06442514
- 其他研究编号
- IIR 22-070, 5I01HX003607
日期
- 首次提交
- (2年前)
- 首次发布
- (2年前)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否