Study on Sit to Quit Phone Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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North Carolina Quit Line: Quit for Life

Participants will be connected to the 'Quit for Life' program offered through the North Carolina Quit Line.

Group Type ACTIVE_COMPARATOR

Quit for Life

Intervention Type 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.

Sit to Quit

Participants will be connected to the 'Sit to Quit' program offered through the Duke Smoking Cessation Program.

Group Type EXPERIMENTAL

Sit to Quit

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Mindfulness Training for Smokers North Carolina Quit Line

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No