Technology and Telephone-Based Smoking Cessation Treatment for Veterans With Posttraumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Acceptability questionnaire
研究概览
简要总结
The goal of the proposed project is to design and assess the acceptability and usability of a mobile technology and telephone-facilitated treatment to improve treatment engagement in adult smokers with posttraumatic stress disorder (PTSD). Smokers with PTSD face high rates of treatment failure and require tailored strategies that address both PTSD symptoms and smoking urges. McFall and Saxon designed a protocol combining office-based therapy plus evidence-based pharmacotherapies for smoking cessation that doubled quit rates in veteran smokers with PTSD. However, high rates of attrition limited efficacy. The investigators aim to enhance scalability and engagement in the McFall/ Saxon protocol by (1) adapting the treatment to be delivered over the video or telephone and (2) leveraging innovations in technology by incorporating a mobile application targeting PTSD and smoking and a mobile carbon monoxide (CO) monitor into the protocol. The investigators propose a mixed methods study in which the investigators will adapt the office-based treatment into a technology and telephone-facilitated intervention and conduct a pilot RCT of the modified intervention with 20 veterans with PTSD. At the outset of the study, the study team will modify the original treatment manual in order for it to be delivered via video or telephone. The investigators will then conduct a pilot RCT in which 20 veterans with PTSD will be randomized to receive the modified protocol (intervention condition; n=10) or the original office-based protocol (control condition, n=10). Main outcomes are quantitative and qualitative data about the acceptability of the intervention and its individual components, and treatment retention at Week 8. Secondary outcomes are 7-day bioverified point-prevalence cigarette abstinence, PTSD symptoms, and levels of nicotine dependence at follow-up. Results will inform a larger RCT to examine efficacy of the intervention in promoting quit attempts in smokers with PTSD.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are a veteran ages 18-69 meeting lifetime criteria for PTSD using the Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) as assessed by the MINI International Neuropsychiatric Interview
- •have smoked at least five cigarettes per day on at least 15 of 30 days before screening
- •are interested in smoking cessation
- •are willing to receive smoking cessation interventions
- •are a smartphone (iOS or Android) user
排除标准
- •women who are pregnant or plan to become pregnant
- •current and unstable psychotic or bipolar disorder (potential participants whose symptoms are treated and stable may participate)
- •current severe psychiatric symptoms or psychiatric instability
- •current severe substance use disorder
- •cognitive impairment assessed by Montreal Cognitive Assessment (MoCA) Score below 23
研究组 & 干预措施
Office Group
干预措施: Office-based treatment protocol (Behavioral)
Telephone Group
干预措施: Telephone-and technology-facilitated treatment protocol (Behavioral)
结局指标
主要结局
Acceptability questionnaire
时间窗: Week 8
Participants (in the intervention condition only) will complete a questionnaire developed by our team to rate the intervention protocol from 1-10 in terms of perceived helpfulness, understandability, and likelihood of use. The mean score (i.e., average of item ratings) will be reported for the participants in the intervention condition. Higher scores represent greater acceptability.
System Usability Scale (SUS) for iCO monitor and Stay Quit Coach (SQC) App
时间窗: Week 8
The SUS is a brief, reliable and valid instrument to measure perceptions of usability of technology devices. Items are rated on a scale from 0-5. An SUS total score is calculated by summing item ratings, and then multiplied the sum by 2.5. The maximum score on the SUS is 100, with higher scores reflecting greater usability. We will administer the SUS to the intervention condition only. Mean usability score will be reported.
Client Satisfaction Questionnaire-8
时间窗: Week 8
The CSQ-8 is an eight-item instrument designed to measure satisfaction with an clinical intervention. Items are rated on a scale from 1-4 and summed to for an CSQ-8 total score. Scores range from 8-32, with higher scores indicating greater satisfaction. We will administer the CSQ-8 to the intervention condition only. Mean satisfaction score will be reported.
Total number of treatment sessions completed
时间窗: Week 1-8
We will record attendance at each session Weeks 1-8 in both arms.
次要结局
- PTSD Checklist (PCL-5)(Weeks 0 & 8)
- Carbon monoxide levels(Weeks 0 & 8)
- Number of cigarettes smoked(Weeks 0 & 8)
- Fagerstrom Test of Nicotine Dependence (FTND) scores(Weeks 0 & 8)