Tech and Telephone Smoking Cessation Treatment for Young Veterans With PTSD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Number of Participants Attending All Intervention Sessions
研究概览
简要总结
This project aims to enhance the scalability of an office-based smoking cessation treatment protocol for veterans with PTSD, integrated care (IC), by adapting it to be delivered over the telephone and to incorporate mobile technology components. Mobile technology components include: (1) the Stay Quit Coach (SQC) mobile application (app), and (2) the iCO® mobile Smokerlyzer®, a smart phone-compatible carbon monoxide monitor.
详细描述
Eighty U.S. military veteran smokers with PTSD, ages 18-45, will be randomized to receive either: (1) the telephone-and technology-facilitated intervention (n=40), or (2) the current standard of care (referral to the VA telephone Quitline) (n=40) as a control. All participants will receive a baseline (Week 0) office visit and will optionally be prescribed nicotine replacement therapy (NRT). Participants in the intervention condition will receive eight 20- to 30-minute video or telephone counseling sessions and be asked to use the SQC app and iCO® Mobile Smokerlyzer®. Control participants will receive up to eight weekly proactive telephone sessions through the VA telephone Quitline. Assessments will occur at baseline (Week 0), treatment end (Week 8), and at three months (Week 12) and six months (Week 24) post-randomization. The primary aims of this pilot randomized controlled trial are: (1) to assess the feasibility and acceptability of the intervention; and (2) to assess the impact of the adapted IC intervention on treatment retention compared to treatment as usual (i.e., VA Quitline).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female veterans eligible for VA services
- •Ages 18 to 45 (inclusive)
- •Meets lifetime criteria for PTSD using the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
- •Smoked at least 5 cigarettes per day for 15 of the past 30 days
- •Interested in smoking cessation and willing to receive interventions
- •A smartphone (iOS or Android) user and comfortable using a smartphone
- •Females must have a negative urine pregnancy test and must be practicing an effective method of birth control (e.g., surgically sterile, spermicide with barrier, male partner sterilization; or abstinent and agrees to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence)
- •Ability to attend screening appointment in-person or via V-tel at San Francisco Veteran's Medical Center (SFVAMC) or an associated clinic and participate in 8 weekly sessions, follow-up sessions at Weeks 12 and 24, and monthly nicotine replacement check-ins
- •Modified inclusion criteria for remote screenings during Coronavirus Disease 2019 (COVID-19) pandemic:
- •Female participants will be required to provide a negative urine pregnancy test if they do not have a verified and reliable form of birth control (at the discretion of the PI). Pregnancy tests will be mailed to the participant and they will be asked to take a photo of the completed test and send it through an encrypted e-mail back to the study team in order to determine eligibility. Participants may also choose to complete urine pregnancy testing at VA lab. This will occur after verbal consent is given.
- •No longer required to be able to attend in-person screening appointment as everything will be done remotely. Potential recruits will need the ability to participate in telephone or secure, 2-way video conferencing "visits" for: Consent and Screening (Week 0), 8 weekly sessions, follow-up sessions at Weeks 12 and 24, and monthly nicotine replacement check-ins.
排除标准
- •Current, unstable psychotic or bipolar disorders
- •Current, severe substance use disorder (SUD) deemed to be unstable by the study physician; individuals with SUD are eligible if their SUD is assessed to be in partial or full remission for 30 days or more at the time of screening, as assessed by Mini International Neuropsychiatric Interview (MINI) , chart review, and the principal investigator (PI).
- •Other psychiatric disorders judged to be unstable in the clinical judgment of the PI or study physician
- •Clinically significant unstable medical conditions, in the clinical judgment of the PI or study physician.
- •Female participants who are pregnant, intend to become pregnant during the study period, and/or are not using an effective method of birth control.
- •Concurrent participation in another smoking cessation study.
结局指标
主要结局
Number of Participants Attending All Intervention Sessions
时间窗: over 8-week intervention period; calculated at Week 8 (post-treatment)
Number of participants attending all intervention sessions.
The Difference in Total Number of Treatment Sessions Attended Between the Experimental Treatment Condition and the Control Condition
时间窗: over 8-week intervention period; calculated at Week 8 (post-treatment)
The difference in total number of treatment sessions attended between the experimental treatment condition and the control condition. Higher adherence rates suggest greater study/intervention feasibility and acceptability, and a large difference score would indicate greater feasibility/acceptability of one study condition over the other.
Acceptability Questionnaire
时间窗: Week 8
Participants (in the intervention condition only) will complete a questionnaire developed by the investigators 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.
Median Scores on the System Usability Scale (SUS)
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. The SUS will be administered to the intervention condition only. Mean usability score will be reported.
Median Scores on the Client Satisfaction Questionnaire-8 (CSQ-8)
时间窗: Week 8 (post-treatment)
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. The CSQ-8 will be administered to the intervention condition only. Mean satisfaction score will be reported.
次要结局
- Average Number of Cigarettes Smoked in the Past 30 Days at Weeks 0, 8, 12 and 24(Weeks 0, 8, 12, and 24)
- Timeline Follow-Back (TLFB): E-cigarettes(Weeks 0, 8, 12, and 24)
- Timeline Follow-Back (TLFB): Chewing Tobacco(Weeks 0, 8, 12, and 24)
- Change in Scores on the Fagerström Test for Nicotine Dependence (FTND)(Weeks 0, 8, 12, and 24)
- Biochemically Verified Point Prevalent Abstinence: 7-day(Weeks 12 and 24)
- Biochemically Verified Point Prevalence Abstinence: 30-day(Weeks 12 and 24)
- Change in Scores on the PTSD Checklist for DSM 5 (PCL-5)(Weeks 0, 8, 12, and 24)