- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03492645
Technology and Telephone-Based Smoking Cessation (RAP Smoking)
September 26, 2019 updated by: University of California, San Francisco
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94121
- San Francisco VA Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Office Group
|
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.
|
Experimental: Telephone Group
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 8
|
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.
|
Week 8
|
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.
|
Week 8
|
Total number of treatment sessions completed
Time Frame: Week 1-8
|
We will record attendance at each session Weeks 1-8 in both arms.
|
Week 1-8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD Checklist (PCL-5)
Time Frame: Weeks 0 & 8
|
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.
|
Weeks 0 & 8
|
Number of cigarettes smoked
Time Frame: Weeks 0 & 8
|
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.
|
Weeks 0 & 8
|
Carbon monoxide levels
Time Frame: Weeks 0 & 8
|
Exhaled CO will be obtained in person with a Covita office Smokerlyzer
|
Weeks 0 & 8
|
Fagerstrom Test of Nicotine Dependence (FTND) scores
Time Frame: Weeks 0 & 8
|
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.
|
Weeks 0 & 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 6, 2018
Primary Completion (Actual)
August 23, 2019
Study Completion (Actual)
August 23, 2019
Study Registration Dates
First Submitted
April 2, 2018
First Submitted That Met QC Criteria
April 2, 2018
First Posted (Actual)
April 10, 2018
Study Record Updates
Last Update Posted (Actual)
September 30, 2019
Last Update Submitted That Met QC Criteria
September 26, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 17-21605
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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