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Completed

NCT Number: NCT02840435

Study on Sit to Quit Phone Intervention

This study is designed to test the effectiveness of the smoking cessation intervention "Sit to Quit" through a randomized-control trial. This study will compare abstinence outcomes in the Sit to Quit study group to a control group using the North Carolina State Tobacco Quit Line.

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Key information

Conditions

Nicotine Dependence Behavior Chemically-Induced Disorders Cigarette Smoking Mental Disorders Smoking Substance-Related Disorders Tobacco Smoking Tobacco Use Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Center for Smoking Cessation

Durham, North Carolina, 27705, United States

About this study

This study is designed to test the effectiveness of the smoking cessation intervention "Sit to Quit" through a randomized-control trial. This study will compare abstinence outcomes in the Sit to Quit study group to a control group using the North Carolina State Tobacco Quit Line. This is an investigational study (n=60) designed to test Sit to Quit (STQ) versus Quit Line (QL) through a pilot randomized control trial. The proposed study is designed with double-blind procedures (participants and study staff) for randomization of 60 participants recruited through Duke Smoking Cessation Program into two groups: STQ and QL. STQ participants will receive access to the STQ Instructional Video, the STQ manual, and proactive Quit Coach calls supporting STQ. QL participants will be instructed to contact the NC Quit Line and will receive access to "web Coach" (Alere Well-being site), the Quit Line manual, and proactive Quit Coach calls supporting "Quit for Life." All statistical analysis will be performed under the directions of the statistician designated in key personnel. Outcomes of variables including: demographic variables, evaluation responses, and abstinence rates will be analyzed using general regression models using an ANOVA-based design. The study Principal Investigator Dr. James Davis will ultimately be responsible for data and safety monitoring. Subject data will be collected during visits and captured in the Electronic Medical Record. Data will be collected by phone, and this data will be stored in REDCap. Participants that experience events related to their clinical treatment will be recommended to follow-up with their provider.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient being treated at Duke Smoking Cessation Program for tobacco use
  • Age 18 years or older
  • Actively smoking 5 or more cigarettes per day for at least one year
  • Fluency in spoken and written English
  • Willing to set a quit date within 2 weeks
  • Access to a smart phone or internet and telephone
  • Willingness to watch 3 videos on computer, receive 5 counseling calls, and attend investigational visits.

Exclusion criteria

  • CO test under 7 ppm during initial screening
  • 8 or above on the Alcohol Use Disorders Identification Test (AUDIT-10)
  • 6 or above on Drug Abuse Screening Test (DAST-10)
  • 3 or above on Patient Health Questionnaire (PHQ-2) Depression Scale
  • Daily use of a second form of tobacco or nicotine (e.g. e-cigarettes, cigars, chewing tobacco, snuff)
  • Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline, Bupropion)
  • Intolerable side effects related to, refusal to take, or medical contraindication with nicotine patch
  • Symptomatic cognitive or emotive disorder such as untreated schizophrenia, severe untreated depression, or severe untreated anxiety. This is determined by clinical assessment.

Treatment and study plan

Sit to Quit

Behavioral

Sit to Quit(STQ) is a smoking cessation program adapted from Mindfulness Training for Smokers (MTS) with core content available on the STQ video. STQ contains many elements found in traditional interventions (e.g. instruction on planning and structuring a quit day, garnering support from others, assessment of prior relapse occasions, development of strategies to avoid triggers). In addition, STQ provides instruction in various mindfulness practices and in how to apply mindfulness skills to manage common causes of relapse. Exercises are provided, and it is recommended to learn the skill experientially. STQ requests that participants practice guided meditation each day using an audio recording and employ other mindfulness practices targeted to manage relapse challenges. Participants will also receive the STQ Participant Manual, which provides all the instruction found in the STQ Video, but provides additional discussion of topics for smokers who desire additional material.

Other names: Mindfulness Training for Smokers

Quit for Life

Behavioral

Quit for Life integrates telephone counseling, written materials, NRT, and an online program called "Web Coach." Web Coach is an interactive internet-based support system that provides health information on smoking cessation, assistance in the development of quit strategies, and an interactive blog to interact with other smokers. Web Coach is used by approximately 70% of AWI callers. Web Coach is not a complete program, but instead is designed to supplement AWI phone-based therapy. In addition, Quit for Life also provides the "Quit Guide," which is a smoking cessation manual with written instructions on the use of medications, planning a quit day, and cessation-related cognitive skills.

Other names: North Carolina Quit Line

Primary outcomes

  1. Biochemically confirmed continuous 30-day abstinence from smoking

    Time frame: 12 weeks post-Target Quit Day (TQD)

    Biochemically confirmed 30-day continuous abstinence. Abstinence is determined by a participant both reporting not smoking in the past 30 days AND a result of < 7 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent

Secondary outcomes

  1. Biochemically confirmed 7-day point prevalence abstinence from smoking

    Time frame: 12 weeks post-TQD

    Biochemically confirmed 7-day continuous abstinence. Abstinence is determined by a participant both reporting not smoking in the past 7 days AND a result of < 7 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent

  2. Biochemically confirmed 7-day point prevalence abstinence from smoking

    Time frame: 2 weeks post-TQD

    Biochemically confirmed 7-day continuous abstinence. Abstinence is determined by a participant both reporting not smoking in the past 7 days AND a result of < 7 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent

  3. Self-reported 7-day point prevalence abstinence rates

    Time frame: 1 week post TQD

    7-day point prevalence abstinence as measured by phone-based, single-item self-report

  4. Self-reported 7-day point prevalence abstinence rates

    Time frame: 12 weeks post TQD

    7-day point prevalence abstinence as measured by phone-based, single-item self-report

  5. Self-reported 7-day point prevalence abstinence rates

    Time frame: 26 weeks post TQD

    7-day point prevalence abstinence as measured by phone-based, single-item self-report

  6. Self-reported 7-day point prevalence abstinence rates

    Time frame: 6 weeks post TQD

    7-day point prevalence abstinence as measured by phone-based, single-item self-report

  7. Self-reported 7-day point prevalence abstinence rates

    Time frame: 2 weeks post TQD

    7-day point prevalence abstinence as measured by phone-based, single-item self-report

  8. Smoking reduction

    Time frame: 1 week post-TQD

    Smoking reduction as measured by number of cpd measured by phone-based self-report

  9. Smoking reduction

    Time frame: 2 weeks post-TQD

    Smoking reduction as measured by number of cpd measured by phone-based self-report

  10. Smoking reduction

    Time frame: 6 weeks post-TQD

    Smoking reduction as measured by number of cpd measured by phone-based self-report

  11. Smoking reduction

    Time frame: 12 weeks post-TQD

    Smoking reduction as measured by number of cpd measured by phone-based self-report

  12. Smoking reduction

    Time frame: 26 weeks post-TQD

    Smoking reduction as measured by number of cpd measured by phone-based self-report

  13. Changes in stress

    Time frame: Baseline to 2-week and 12-week post TQD

    Change in self-reported measures of stress

  14. Changes in anxiety

    Time frame: Baseline to 2-week and 12-week post TQD

    Change in self-reported measures of anxiety

  15. Changes in depression

    Time frame: Baseline to 2-week and 12-week post TQD

    Change in self-reported measures of depression

  16. Changes in relapse predictors

    Time frame: Baseline to 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, 12-week post-TQD, and 26-week post-TQD

    Changes in self-reported measures on repeated non-standardized single-item question on stress, urges, and confidence assessed by phone

  17. Feasibility: attendance records

    Time frame: Up to 12 weeks post-TQD

    Feasibility as measured by attendance and completion of STQ and QL assessed by attendance records taken instructors during phone sessions.

  18. Feasibility: website usage

    Time frame: Up to 12 weeks post-TQD

    Feasibility as measured by website usage by electronically recording login and using a site-based timer to record time accessing the site through each intervention

  19. Feasibility: course evaluation

    Time frame: Up to 12 weeks post-TQD

    Feasibility as measured by course evaluation

  20. Feasibility: demographics

    Time frame: 12-weeks post-TQD

    Feasibility as measured by demographics of patients at DSCP

  21. Feasibility: Behavioral intervention used

    Time frame: 12 weeks post-TQD

    Feasibility as measured by behavioral intervention assignment

  22. Feasibility: Attendance at DSCP appointments

    Time frame: 12 weeks post-TQD

    Feasibility as measured by attendance at DSCP appointments

  23. Feasibility: Referral routes to DSCP

    Time frame: Baseline

    Feasibility as measured by referral routes to DSCP

  24. Feasibility: Side effects

    Time frame: 1-week post-TQD, 2-week post-TQD, and 6-week post-TQD

    Feasibility as measured by side effects, as measured by phone assessment

  25. Feasibility: medication adherence

    Time frame: 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD

    Feasibility as measured by medication adherence, as measured by phone assessment

  26. Feasibility: mindfulness practices

    Time frame: 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD

    Feasibility as measured by non-standardized phone-based self-report of number of times mindfulness practices are used by experimental group

  27. Feasibility: meditation time

    Time frame: 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD

    Feasibility as measured by non-standardized phone-based self-report of time spent meditating by experimental group

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Consumer Wellness Solutions
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Pilot Study on Mindfulness Training for Smokers Via Web-based Video and Telephone Counseling

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2016
Registry last updated
Sep 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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