Technology and Telephone-Based Smoking Cessation

NCT ID: NCT03492645

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-06
• Study Completion Date: 2019-08-23

Brief 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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Office Group

Group Type: ACTIVE_COMPARATOR

Office-based treatment protocol

Intervention Type: BEHAVIORAL

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.

Telephone Group

Group Type: EXPERIMENTAL

Telephone-and technology-facilitated treatment protocol

Intervention Type: BEHAVIORAL

1. 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.

2. 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.

3. 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.

Interventions

Telephone-and technology-facilitated treatment protocol

1. 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.

2. 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.

3. 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.

Intervention Type: BEHAVIORAL

Office-based treatment protocol

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ellen Herbst, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

San Francisco VA Medical Center

San Francisco, California, United States

Countries

United States

Other Identifiers

17-21605

Identifier Type: -

Identifier Source: org_study_id