Feasibility of Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly (≤10 Cigarettes Per Day) or Non-daily
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility as measured by the number of participants who are recruited and randomized
研究概览
简要总结
This study aims to test the feasibility and acceptability of a remotely delivered cue-based treatment intervention to promote smoking cessation among people who smoke lightly or non-daily. Secondary objectives include assessing preliminary efficacy on cessation and examining cue reactivity. Participants will be randomized to CBT only or CBT + cue-based treatment, with assessments at baseline, end-of-treatment, 6 months, and 12 months.
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
- •Able to read and understand English or Spanish
- •Smoke 1-10 cigarettes/day on at least 4 days of the past two weeks for the last year
- •Willing to try quitting in next 30 days
- •Access to cell phone with texting capabilities
排除标准
- •Current participation in another smoking cessation study
- •Unable to provide consent
- •Refusal to abstain from e-cigarettes or other tobacco products
- •Use of medications affecting smoking cessation (e.g., Chantix, Wellbutrin)
研究组 & 干预措施
CBT only
CBT delivered via telehealth sessions and supportive text messages.
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
CBT + Cue-based treatment
CBT plus cue-based treatment includes exposure to smoking-related cues and coping strategies.
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
CBT + Cue-based treatment
CBT plus cue-based treatment includes exposure to smoking-related cues and coping strategies.
干预措施: Cue-based treatment intervention (Behavioral)
结局指标
主要结局
Feasibility as measured by the number of participants who are recruited and randomized
时间窗: During the recruitment period (up to 9 months)
Feasibility as measured by the number of participants who respond to pre-quit real-time data collection
时间窗: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who take pictures of smoking/craving situations
时间窗: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who complete all CBT (cognitive behavioral therapy) sessions
时间窗: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who complete all cue-based treatment sessions
时间窗: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who respond to EMA text based assessments
时间窗: End of treatment (up to 12 months)
Feasibility as measured by the number of participants who proactively text to report cravings
时间窗: End of treatment (up to 12 months)
Acceptability of CBT + cue-based treatment intervention compared to CBT only
时间窗: End of treatment (up to 12 months)
We will assess acceptability quantitatively and qualitatively. We will assess message helpfulness (1=Not at all helpful to 5=extremely helpful) and whether participants would recommend the program to a friend (1=definitely would not recommend to 5=definitely would recommend). We will also assess participant fidelity to the intervention protocol (e.g., experienced cues and texted to report when experiencing a cue). Qualitative data will be used to describe barriers and facilitators to intervention uptake among participants in the CBT + cue-based treatment arm.
次要结局
- Number of participants reporting the presence of smoking cues(7 days after end of each CBT session (4 sessions total))
- Craving level(7 days after end of each CBT session (4 sessions total))
- Stress level(7 days after end of each CBT session (4 sessions total))
- Current mood(7 days after end of each CBT session (4 sessions total))
- Number of participants who reported 30-day point prevalence abstinence(End of Treatment, 6 months)
- Smoking status as measured by salivary cotinine(End of Treatment, 6 months)