Tech and Telephone Smoking Cessation Treatment for Young Veterans With PTSD

NCT03552978 | Completed Results DMC

• 3 other identifiers: 17-22551NCI-2022-0968122634
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to enhance the scalability of an office-based smoking cessation treatment protocol for veterans with PTSD, integrated care (IC), by adapting it to be delivered over the telephone and to incorporate mobile technology components. Mobile technology components include: (1) the Stay Quit Coach (SQC) mobile application (app), and (2) the iCO® mobile Smokerlyzer®, a smart phone-compatible carbon monoxide monitor.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (5)

• Number of Participants Attending All Intervention Sessions

  Number of participants attending all intervention sessions.

  over 8-week intervention period; calculated at Week 8 (post-treatment)

• The Difference in Total Number of Treatment Sessions Attended Between the Experimental Treatment Condition and the Control Condition

  The difference in total number of treatment sessions attended between the experimental treatment condition and the control condition. Higher adherence rates suggest greater study/intervention feasibility and acceptability, and a large difference score would indicate greater feasibility/acceptability of one study condition over the other.

  over 8-week intervention period; calculated at Week 8 (post-treatment)

• Acceptability Questionnaire

  Participants (in the intervention condition only) will complete a questionnaire developed by the investigators 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

• Median Scores on the System Usability Scale (SUS)

  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. The SUS will be administered to the intervention condition only. Mean usability score will be reported.

  Week 8

• Median Scores on the Client Satisfaction Questionnaire-8 (CSQ-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. The CSQ-8 will be administered to the intervention condition only. Mean satisfaction score will be reported.

  Week 8 (post-treatment)

Secondary Outcomes (7)

• Average Number of Cigarettes Smoked in the Past 30 Days at Weeks 0, 8, 12 and 24

  Weeks 0, 8, 12, and 24

• Timeline Follow-Back (TLFB): E-cigarettes

  Weeks 0, 8, 12, and 24

• Timeline Follow-Back (TLFB): Chewing Tobacco

  Weeks 0, 8, 12, and 24

• Change in Scores on the Fagerström Test for Nicotine Dependence (FTND)

  Weeks 0, 8, 12, and 24

• Biochemically Verified Point Prevalent Abstinence: 7-day

  Weeks 12 and 24

Other Outcomes (2)

• Timeline Follow-Back (TLFB): Other Tobacco Products

  Weeks 0, 8, 12, and 24

• Proportion of Participants Recruited Based on Region

  over 8-week intervention period; calculated at Week 8 (post-treatment)

Study Arms (2)

Tech-facilitated IC intervention

EXPERIMENTAL

After completing an initial 2-hour screening visit that includes a series of questionnaires assessing eligibility criteria and meeting with the study physician to review medical history, participants will be offered nicotine replacement therapy (NRT) at baseline (Week 0), per VA prescribing guidelines, nicotine dependence levels, and participant preference. Participants will then receive 8 counseling sessions (video or telephone). The first session lasts 45-60 min, and the remaining 7 sessions last 20-30 min. Participants will be asked to use the Stay Quit Coach (SQC) app between sessions, and the iCO® Smokerlyzer®

Behavioral: Tech-Facilitated IC Intervention

VA Quitline

ACTIVE COMPARATOR

After completing an initial 2-hour screening visit that includes a series of questionnaires assessing eligibility criteria and meeting with the study physician to review medical history, participants will be offered nicotine replacement therapy (NRT) at baseline (Week 0), per VA prescribing guidelines, nicotine dependence levels, and participant preference. Participants will also receive weekly proactive telephone sessions through the VA Quitline, a standard of care, proactive telephone quitline available to all veterans for up to eight weeks. Participants will initiate the first call and subsequent calls will be made by the Quitline counselor.

Behavioral: VA Quitline

Interventions

Tech-Facilitated IC Intervention BEHAVIORAL

The Integrated Care (IC) treatment protocol for smoking cessation is a PTSD-informed intervention that has been adapted to be delivered over video or telephone and to incorporate technological components, including the Stay Quit Coach (SQC) smart phone application (app) which is a public domain, no-cost mobile app designed to complement the IC protocol with evidence-based tools to support smoking cessation. and the coVita Bedfont® Scientific Ltd iCO® Smokerlyzer® device and app which is a mobile carbon monoxide (CO) monitor that provides CO readings in order to self-monitor progress in quitting. The coVita mobile app is compatible with iOS \&Android and used with the iCO® Smokerlyzer® to display CO readings. Content of sessions is consistent with that delivered in the IC treatment protocol for veteran smokers with post-traumatic stress disorder (PTSD).

Tech-facilitated IC intervention

VA Quitline BEHAVIORAL

The SFVAMC's standard of care referral service, known as the VA Quitline which involves weekly telephone sessions through the VA's proactive telephone Quitline, available to all veterans for up to 8 weeks.

VA Quitline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female veterans eligible for VA services
• Ages 18 to 45 (inclusive)
• Meets lifetime criteria for PTSD using the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
• Smoked at least 5 cigarettes per day for 15 of the past 30 days
• Interested in smoking cessation and willing to receive interventions
• A smartphone (iOS or Android) user and comfortable using a smartphone
• Females must have a negative urine pregnancy test and must be practicing an effective method of birth control (e.g., surgically sterile, spermicide with barrier, male partner sterilization; or abstinent and agrees to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence)
• Ability to attend screening appointment in-person or via V-tel at San Francisco Veteran's Medical Center (SFVAMC) or an associated clinic and participate in 8 weekly sessions, follow-up sessions at Weeks 12 and 24, and monthly nicotine replacement check-ins
• \. Female participants will be required to provide a negative urine pregnancy test if they do not have a verified and reliable form of birth control (at the discretion of the PI). Pregnancy tests will be mailed to the participant and they will be asked to take a photo of the completed test and send it through an encrypted e-mail back to the study team in order to determine eligibility. Participants may also choose to complete urine pregnancy testing at VA lab. This will occur after verbal consent is given.
• \. No longer required to be able to attend in-person screening appointment as everything will be done remotely. Potential recruits will need the ability to participate in telephone or secure, 2-way video conferencing "visits" for: Consent and Screening (Week 0), 8 weekly sessions, follow-up sessions at Weeks 12 and 24, and monthly nicotine replacement check-ins.

You may not qualify if:

• Current, unstable psychotic or bipolar disorders
• Dementia
• Current, severe substance use disorder (SUD) deemed to be unstable by the study physician; individuals with SUD are eligible if their SUD is assessed to be in partial or full remission for 30 days or more at the time of screening, as assessed by Mini International Neuropsychiatric Interview (MINI) , chart review, and the principal investigator (PI).
• Other psychiatric disorders judged to be unstable in the clinical judgment of the PI or study physician
• Clinically significant unstable medical conditions, in the clinical judgment of the PI or study physician.
• Female participants who are pregnant, intend to become pregnant during the study period, and/or are not using an effective method of birth control.
• Concurrent participation in another smoking cessation study.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Tobacco Related Disease Research Program: collaborator
• San Francisco Veterans Affairs Medical Center: collaborator
• Northern California Institute of Research and Education: collaborator

Study Sites (1)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Results Point of Contact

• Title: Ellen Herbst, MD
• Organization: San Francisco Veterans Affairs Medical Center

Ellen.Herbst@va.gov

415-221-4810

Study Officials

• Ellen Herbst, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 12, 2018
• Study Start: February 13, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 9, 2025
• Results First Posted: April 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)