Culturally Sensitive, Evidence-based, Spanish Language Mobile App for Smoking Cessation for Latino Cigarette Smokers
试验速览
- 阶段
- 不适用
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- 7-Day Point Prevalence Smoking Abstinence
研究概览
简要总结
The specific aims of the project are to develop and test a Spanish language, mobile app for smoking cessation called Impacto.
详细描述
A total of 38 Spanish-speaking, Latinx smokers with high anxiety sensitivity (AS) will be recruited for this project. Eight (8) participants will complete user interviews in Spanish and thirty (30) participants will participate in a randomized controlled trial (RCT) for smoking cessation. Participants will be randomized to receive either the Impacto mobile app or a generic, Spanish language, smoking cessation, mobile app control (Dejar de Fumar Asistente).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 55 year of age, 2) current smoker (i.e., at least 6 cigarettes/day), 3) not currently engaged in smoking cessation treatment, 4), high anxiety sensitivity (AS) score defined as an ASI-III score of ≥ 23, 5) motivation to quit > 5 on a 10 pt. scale, 6) Spanish speaking, and 7) currently own an Android-compatible mobile phone.
排除标准
- •use of other tobacco products (including e-cigarettes), 2) current non-nicotine substance dependence and/or current or intended participation in a concurrent substance abuse treatment, 3) ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or depression, or 4) active suicidality (i.e., suicidal ideation, intent, and/or plan) or current psychosis
结局指标
主要结局
7-Day Point Prevalence Smoking Abstinence
时间窗: End of treatment (Week 8)
Self-reported 7-day point prevalence smoking status. Verification via carbon monoxide at end of treatment (10 weeks).
Change in Smoking Rate (# cigarettes per day)
时间窗: Baseline and Weeks 2, 4, 6, and end of treatment (Week 8)
We will assess the number of cigarettes smoking at each time point.
次要结局
- Daily Adherence to Use of Impacto Mobile App (Impacto Condition Only)(Daily over the course of the 8 weeks of participant study involvement)
- User Satisfaction with the Impacto Mobile App (Impacto Condition Only) Condition Only)(Weeks 2, 4, 6, and 8)
- Change in Mood and Anxiety Symptoms(Baseline and Weeks 2, 4, 6, and end of treatment (Week 8))
- Change in Anxiety Sensitivity(Baseline and Weeks 2, 4, 6, and end of treatment (Week 8))
研究者
Michael J. Zvolensky, Ph.D.
Hugh Roy and Lillie Cranz Cullen Distinguished University Professor
University of Houston