Smoking CessationRAP SmokingNCT03492645
Technology and Telephone-Based Smoking Cessation
A study testing Telephone-and technology-facilitated treatment protocol and Office-based treatment protocol in people with Smoking Cessation, run by University of California, San Francisco at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Telephone-and technology-facilitated treatment protocol and Office-based treatment protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2018to 23 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center
San Francisco, California, 94121
About this study
Official title: Technology and Telephone-Based Smoking Cessation Treatment for Veterans With Posttraumatic Stress Disorder
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
- Being tested
- Telephone-and technology-facilitated treatment protocol, Office-based treatment protocol
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-and technology-facilitated treatment protocolBehavioural
- 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.
Office-based treatment protocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Office Group | Active comparator | Not described Receives: Behavioral: Office-based treatment protocol |
| Telephone Group | Experimental | Not described Receives: Behavioral: Telephone-and technology-facilitated treatment protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale (SUS) for iCO monitor and Stay Quit Coach (SQC) App
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.
Measured: Week 8
Acceptability questionnaire
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.
Measured: Week 8
Client Satisfaction Questionnaire-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.
Measured: Week 8
Total number of treatment sessions completed
We will record attendance at each session Weeks 1-8 in both arms.
Measured: Week 1-8
Secondary outcomes (4)
PTSD Checklist (PCL-5)
The PCL-5 is a 20-item self-report measure that assesses the severity of the twenty DSM-V symptoms of PTSD. Items are rated on a 1-5 scale and summed to compute a total score, with higher scores representing greater severity of PTSD symptoms. This outcome variable will be reported as the difference in PCL-5 total score between the experimental treatment condition and the control condition.
Measured: Weeks 0 & 8
Number of cigarettes smoked
Self-reported use of cigarettes will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity and frequency of use. This outcome variable will be reported as the difference in cigarette use between the experimental treatment condition and the control condition.
Measured: Weeks 0 & 8
Carbon monoxide levels
Exhaled CO will be obtained in person with a Covita office Smokerlyzer
Measured: Weeks 0 & 8
Fagerstrom Test of Nicotine Dependence (FTND) scores
The FTND is a validated, 6-item self-report instrument that evaluates the intensity of physical addiction to nicotine. Three items are rated yes/no (0/1), and the other three items are rated on a scale from 0-3. Items are summed to yield a total score of 0-10, with higher scores reflecting greater nicotine dependence. This outcome variable will be reported as the difference in FTND total score between the experimental treatment condition and the control condition.
Measured: Weeks 0 & 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start6 Dec 2018
- Primary completion23 Aug 2019
- Study completion23 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen Herbst, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492645
- Sponsor's protocol ID
- 17-21605
- Acronym
- RAP Smoking
- Status last verified
- Sep 2019
- First submitted
- 2 Apr 2018
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology and Telephone-Based Smoking Cessation Treatment for Veterans With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT03492645
- Acronym / sponsor ID
- RAP Smoking / 17-21605
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 23 Aug 2019 (actual)
- Study completion
- 23 Aug 2019 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Office Group | Active comparator | Behavioral: Office-based treatment protocol |
| Telephone Group | Experimental | Behavioral: Telephone-and technology-facilitated treatment protocol |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone-and technology-facilitated treatment protocol1. 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. | Behavioural | Telephone Group |
| Office-based treatment protocolWeekly 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. | Behavioural | Office Group |
Primary outcome
System Usability Scale (SUS) for iCO monitor and Stay Quit Coach (SQC) App
Time frame: 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.
Acceptability questionnaire
Time frame: 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.
Client Satisfaction Questionnaire-8
Time frame: 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
Time frame: Week 1-8
We will record attendance at each session Weeks 1-8 in both arms.
4 secondary outcomes
PTSD Checklist (PCL-5)
Time frame: Weeks 0 & 8
Number of cigarettes smoked
Time frame: Weeks 0 & 8
Carbon monoxide levels
Time frame: Weeks 0 & 8
Fagerstrom Test of Nicotine Dependence (FTND) scores
Time frame: Weeks 0 & 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Recruiting
Personalized Tobacco Treatment in Primary Care (MOTIVATE)
Physician's Role, Smoking Cessation
RecruitingPhase 3
Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
Cigarette Smoking-Related Carcinoma
Active, not recruitingPhase 4
Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites
Smoking Cessation
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students in Cairo University
Conversational Agent, Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Herbst, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-and technology-facilitated treatment protocol and Office-based treatment protocol in people with Smoking Cessation, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (SUS) for iCO monitor and Stay Quit Coach (SQC) App (time frame: Week 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.