Summary

for people ages 18-69 (full criteria)
study started
estimated completion:
Ellen Herbst

Description

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 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 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.

Official Title

Technology and Telephone-Based Smoking Cessation Treatment for Veterans With Posttraumatic Stress Disorder

Keywords

Smoking Cessation Telephone-and technology-facilitated treatment protocol Office-based treatment protocol

Eligibility

You can join if…

Open to people ages 18-69

  • 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.

You CAN'T join if...

-lifetime psychotic or bipolar disorder, current severe psychiatric symptoms or psychiatric instability, current moderate to severe substance use disorder, or cognitive impairment assessed by Montreal Cognitive Assessment (MoCA)49 Score below 26.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03492645
Lead Scientist
Ellen Herbst
Study Type
Interventional
Last Updated
August 23, 2018