Technology and Telephone-Based Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Telephone-and technology-facilitated treatment protocol; Office-based treatment protocol
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 video or telephone counseling sessions targeting PTSD symptoms related to smoking lapse. The first of these sessions will last approximately 45-60 minutes, and the remaining 7 sessions will last 20-30 minutes.
Use of the Stay Quit Coach (SQC) app between sessions. SQC is a public domain, no-cost mobile app designed by our co-investigators at the National Center for PTSD to complement the IC protocol with evidence-based tools to support smoking cessation, such as motivational messaging and coping tools for managing PTSD symptoms associated with smoking lapse.
Use of the Covita Bedfont iCO Smokerlyzer, a mobile carbon monoxide (CO) monitor, compatible with iOS and Android smartphones, that provides CO readings to the user at any time in order to self-monitor progress in quitting. The Covita iCO mobile app is used with the iCO Smoerlyzer to display CO readings.; Weekly face-to-face sessions using the unmodified treatment manual developed by McFall and Saxon, a protocol combining office-based therapy plus evidence-based pharmacotherapies for smoking cessation that doubled quit rates in veteran smokers with PTSD.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment