Study on Sit to Quit Phone Intervention

Nicotine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02840435
• Other study ID #: Pro00073392
• Secondary ID: P50DA027840
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: June 2018

Study information

• Verified date: September 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• Sit to Quit
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.
• Quit for Life
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.

Locations

Country	Name	City	State
United States	Duke Center for Smoking Cessation	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Alere Wellbeing, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemically confirmed continuous 30-day abstinence from smoking	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	12 weeks post-Target Quit Day (TQD)
Secondary	Biochemically confirmed 7-day point prevalence abstinence from smoking	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	12 weeks post-TQD
Secondary	Biochemically confirmed 7-day point prevalence abstinence from smoking	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 weeks post-TQD
Secondary	Self-reported 7-day point prevalence abstinence rates	7-day point prevalence abstinence as measured by phone-based, single-item self-report	1 week post TQD
Secondary	Self-reported 7-day point prevalence abstinence rates	7-day point prevalence abstinence as measured by phone-based, single-item self-report	12 weeks post TQD
Secondary	Self-reported 7-day point prevalence abstinence rates	7-day point prevalence abstinence as measured by phone-based, single-item self-report	26 weeks post TQD
Secondary	Self-reported 7-day point prevalence abstinence rates	7-day point prevalence abstinence as measured by phone-based, single-item self-report	6 weeks post TQD
Secondary	Self-reported 7-day point prevalence abstinence rates	7-day point prevalence abstinence as measured by phone-based, single-item self-report	2 weeks post TQD
Secondary	Smoking reduction	Smoking reduction as measured by number of cpd measured by phone-based self-report	1 week post-TQD
Secondary	Smoking reduction	Smoking reduction as measured by number of cpd measured by phone-based self-report	2 weeks post-TQD
Secondary	Smoking reduction	Smoking reduction as measured by number of cpd measured by phone-based self-report	6 weeks post-TQD
Secondary	Smoking reduction	Smoking reduction as measured by number of cpd measured by phone-based self-report	12 weeks post-TQD
Secondary	Smoking reduction	Smoking reduction as measured by number of cpd measured by phone-based self-report	26 weeks post-TQD
Secondary	Changes in stress	Change in self-reported measures of stress	Baseline to 2-week and 12-week post TQD
Secondary	Changes in anxiety	Change in self-reported measures of anxiety	Baseline to 2-week and 12-week post TQD
Secondary	Changes in depression	Change in self-reported measures of depression	Baseline to 2-week and 12-week post TQD
Secondary	Changes in relapse predictors	Changes in self-reported measures on repeated non-standardized single-item question on stress, urges, and confidence assessed by phone	Baseline to 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, 12-week post-TQD, and 26-week post-TQD
Secondary	Feasibility: attendance records	Feasibility as measured by attendance and completion of STQ and QL assessed by attendance records taken instructors during phone sessions.	Up to 12 weeks post-TQD
Secondary	Feasibility: website usage	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	Up to 12 weeks post-TQD
Secondary	Feasibility: course evaluation	Feasibility as measured by course evaluation	Up to 12 weeks post-TQD
Secondary	Feasibility: demographics	Feasibility as measured by demographics of patients at DSCP	12-weeks post-TQD
Secondary	Feasibility: Behavioral intervention used	Feasibility as measured by behavioral intervention assignment	12 weeks post-TQD
Secondary	Feasibility: Attendance at DSCP appointments	Feasibility as measured by attendance at DSCP appointments	12 weeks post-TQD
Secondary	Feasibility: Referral routes to DSCP	Feasibility as measured by referral routes to DSCP	Baseline
Secondary	Feasibility: Side effects	Feasibility as measured by side effects, as measured by phone assessment	1-week post-TQD, 2-week post-TQD, and 6-week post-TQD
Secondary	Feasibility: medication adherence	Feasibility as measured by medication adherence, as measured by phone assessment	1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD
Secondary	Feasibility: mindfulness practices	Feasibility as measured by non-standardized phone-based self-report of number of times mindfulness practices are used by experimental group	1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD
Secondary	Feasibility: meditation time	Feasibility as measured by non-standardized phone-based self-report of time spent meditating by experimental group	1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD