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Tech and Telephone Smoking Cessation Treatment for Young Veterans With PTSD

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ClinicalTrials.gov Identifier: NCT03552978
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : February 18, 2019
Sponsor:
Collaborators:
Tobacco Related Disease Research Program
San Francisco Veterans Affairs Medical Center
Northern California Institute of Research and Education
Information provided by (Responsible Party):
University of California, San Francisco

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 smartphone-compatible carbon monoxide monitor. Eighty U.S. military veteran smokers with PTSD, ages 18-39, will be randomized to receive either: (1) the telephone-and technology-facilitated intervention (n=40), or (2) the current standard of care (referral to the VA telephone Quitline) (n=40) as a control. All participants will receive a baseline (Week 0) office visit and will optionally be prescribed nicotine replacement therapy (NRT). Participants in the intervention condition will receive eight 20- to 30-minute video or telephone counseling sessions and be asked to use the SQC app and iCO Mobile Smokerlyzer. Control participants will receive up to eight weekly proactive telephone sessions through the VA telephone Quitline. Assessments will occur at baseline (Week 0), treatment end (Week 8), and at three months (Week 12) and six months (Week 24) post-randomization. The primary aims of this pilot randomized controlled trial are: (1) to assess the feasibility and acceptability of the intervention; and (2) to assess the impact of the adapted IC intervention on treatment retention compared to treatment as usual (i.e., VA Quitline).

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Tech-Facilitated IC Intervention Behavioral: VA Quitline Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tech and Telephone Smoking Cessation Treatment for Young Veterans With PTSD
Actual Study Start Date : February 13, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tech-facilitated IC intervention
  1. Complete 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.
  2. Be offered nicotine replacement therapy (NRT) at baseline (Week 0), per VA prescribing guidelines, nicotine dependence levels, and participant preference.
  3. Receive 8 video or telephone counseling sessions for smoking cessation. The first session lasts 45-60 min, and the remaining 7 sessions last 20-30 min.
  4. Be asked to use the Stay Quit Coach (SQC) app between sessions. SQC is a public domain, no-cost mobile app designed to complement the IC protocol with evidence-based tools to support smoking cessation.
  5. Be asked to use the Covita Bedfont iCO Smokerlyzer, a mobile carbon monoxide (CO) monitor that provides CO readings in order to self-monitor progress in quitting. The Covita mobile app (compatible with iOS and Android) is used with the iCO Smokerlyzer to display CO readings.
Behavioral: Tech-Facilitated IC Intervention
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) smartphone application (app) and the iCO Smokerlyzer device and app. Content of sessions is consistent with that delivered in the IC treatment protocol for veteran smokers with posttraumatic stress disorder (PTSD). The experimental intervention condition in the proposed study differs from the standard of care in that participants will be receiving tailored, individualized smoking cessation counseling for veterans with PTSD.

Active Comparator: Treatment as usual (VA Quitline)
  1. Complete 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.
  2. Be offered nicotine replacement therapy (NRT) at baseline (Week 0), per VA prescribing guidelines, nicotine dependence levels, and participant preference.
  3. Receive weekly proactive telephone sessions through the VA telephone Quitline, a 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
Participants in the control condition will receive the VA's standard care, which is referral to the VA Quitline. This active control condition involves weekly telephone sessions through the VA's proactive telephone Quitline, which is available to all veterans for up to 8 weeks. Participants will initiate the first call, and subsequent calls will be made by the Quitline counselor.




Primary Outcome Measures :
  1. Feasibility: Recruitment [ Time Frame: over 8-week intervention period; calculated at Week 8 (post-treatment) ]
    The difference in recruitment rates among residents of rural versus urban areas. Higher recruitment rates suggest greater study and intervention feasibility, and a large difference score would indicate greater feasibility based on type of residential area.

  2. Feasibility: Intervention Adherence [ Time Frame: 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. 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.

  3. Feasibility: Retention/Attrition [ Time Frame: over 8-week intervention period; calculated at Week 8 (post-treatment) ]
    The difference in study drop-out rates between the experimental treatment condition and the control condition. Higher drop-out rates suggest poorer study/intervention feasibility and acceptability, and a large difference score would indicate greater feasibility/acceptability of one study condition over the other.

  4. Acceptability Questionnaire [ Time Frame: Week 8 ]
    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.

  5. System Usability Scale (SUS) [ 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. The SUS will be administered to the intervention condition only. Mean usability score will be reported.

  6. Client Satisfaction Questionnaire-8 (CSQ-8) [ Time Frame: Week 8 (post-treatment) ]
    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.


Secondary Outcome Measures :
  1. Timeline Follow-Back (TLFB): Cigarettes [ Time Frame: Weeks 0, 8, 12, and 24 ]
    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.

  2. Timeline Follow-Back (TLFB): E-cigarettes [ Time Frame: Weeks 0, 8, 12, and 24 ]
    Self-reported use of e-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 e-cigarette use between the experimental treatment condition and the control condition.

  3. Timeline Follow-Back (TLFB): Chewing tobacco [ Time Frame: Weeks 0, 8, 12, and 24 ]
    Self-reported use of chewing tobacco 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 chewing tobacco use between the experimental treatment condition and the control condition.

  4. Timeline Follow-Back (TLFB): Other tobacco products [ Time Frame: Weeks 0, 8, 12, and 24 ]
    Self-reported use of any other tobacco products 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 use of other tobacco products between the experimental treatment condition and the control condition.

  5. Fagerström Test for Nicotine Dependence (FTND) [ Time Frame: Weeks 0, 8, 12, and 24 ]
    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.

  6. Bioverified point prevalence abstinence: 7-day [ Time Frame: Weeks 12 and 24 ]
    Seven-day point prevalence abstinence rates will be confirmed by salivary cotinine levels. This outcome variable will be reported as the difference in abstinence rates between the experimental treatment condition and the control condition

  7. Bioverified point prevalence abstinence: 30-day [ Time Frame: Weeks 12 and 24 ]
    30-day point prevalence abstinence rates will be confirmed by salivary cotinine levels. This outcome variable will be reported as the difference in abstinence rates between the experimental treatment condition and the control condition

  8. PTSD Checklist-5 (PCL-5) [ Time Frame: Weeks 0, 8, 12, and 24 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female veterans eligible for VA services.
  • Ages 18 to 39 (inclusive).
  • Meets lifetime criteria for PTSD using the 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 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.

Exclusion Criteria:

  • Current, unstable psychotic or bipolar disorders; dementia; current, severe substance use disorder deemed to be unstable by the study physician; or other psychiatric disorders judged to be unstable in the clinical judgment of the PI or study physician.
  • Montreal Cognitive Assessment (MoCA) score below 23, reflective of substantial cognitive impairment.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552978


Contacts
Contact: Ellen Herbst, MD (415) 221-4810 ext 24926 Ellen.Herbst@va.gov
Contact: Shahrzad Daryani, BA (415) 221-4810 ext 23097 Shahrzad.Daryani@va.gov

Locations
United States, California
San Francisco VA Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Ellen Herbst, MD    415-221-4810 ext 24926    Ellen.Herbst@va.gov   
Contact: Shahrzad Daryani, BA    (415) 221-4810 ext 23097    Shahrzad.Daryani@va.gov   
Sponsors and Collaborators
University of California, San Francisco
Tobacco Related Disease Research Program
San Francisco Veterans Affairs Medical Center
Northern California Institute of Research and Education
Investigators
Principal Investigator: Ellen Herbst, MD University of California, San Francisco

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03552978     History of Changes
Other Study ID Numbers: 17-22551
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No