Study on Sit to Quit Phone Intervention

September 12, 2019 updated by: Duke University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Center for Smoking Cessation

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: North Carolina Quit Line: Quit for Life
Participants will be connected to the 'Quit for Life' program offered through the North Carolina Quit Line.
Behavioral: 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.
Other Names:
  • North Carolina Quit Line
Experimental: Sit to Quit
Participants will be connected to the 'Sit to Quit' program offered through the Duke Smoking Cessation Program.
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.
Other Names:
  • Mindfulness Training for Smokers

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 weeks post-Target Quit Day (TQD)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
2 weeks post-TQD
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
12 weeks post-TQD
Feasibility: Behavioral intervention used
Time Frame: 12 weeks post-TQD
Feasibility as measured by behavioral intervention assignment
12 weeks post-TQD
Feasibility: Attendance at DSCP appointments
Time Frame: 12 weeks post-TQD
Feasibility as measured by attendance at DSCP appointments
12 weeks post-TQD
Feasibility: Referral routes to DSCP
Time Frame: Baseline
Feasibility as measured by referral routes to DSCP
Baseline
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
1 week post TQD
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
12 weeks post TQD
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
26 weeks post TQD
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
6 weeks post TQD
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
2 weeks post TQD
Smoking reduction
Time Frame: 1 week post-TQD
Smoking reduction as measured by number of cpd measured by phone-based self-report
1 week post-TQD
Smoking reduction
Time Frame: 2 weeks post-TQD
Smoking reduction as measured by number of cpd measured by phone-based self-report
2 weeks post-TQD
Smoking reduction
Time Frame: 6 weeks post-TQD
Smoking reduction as measured by number of cpd measured by phone-based self-report
6 weeks post-TQD
Smoking reduction
Time Frame: 12 weeks post-TQD
Smoking reduction as measured by number of cpd measured by phone-based self-report
12 weeks post-TQD
Smoking reduction
Time Frame: 26 weeks post-TQD
Smoking reduction as measured by number of cpd measured by phone-based self-report
26 weeks post-TQD
Changes in stress
Time Frame: Baseline to 2-week and 12-week post TQD
Change in self-reported measures of stress
Baseline to 2-week and 12-week post TQD
Changes in anxiety
Time Frame: Baseline to 2-week and 12-week post TQD
Change in self-reported measures of anxiety
Baseline to 2-week and 12-week post TQD
Changes in depression
Time Frame: Baseline to 2-week and 12-week post TQD
Change in self-reported measures of depression
Baseline to 2-week and 12-week post TQD
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
Baseline to 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, 12-week post-TQD, and 26-week post-TQD
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.
Up to 12 weeks post-TQD
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
Up to 12 weeks post-TQD
Feasibility: course evaluation
Time Frame: Up to 12 weeks post-TQD
Feasibility as measured by course evaluation
Up to 12 weeks post-TQD
Feasibility: demographics
Time Frame: 12-weeks post-TQD
Feasibility as measured by demographics of patients at DSCP
12-weeks post-TQD
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
1-week post-TQD, 2-week post-TQD, and 6-week post-TQD
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
1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD
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
1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD
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
1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
Consumer Wellness Solutions

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00073392
  • P50DA027840 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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