iQuit Mindfully: Text Messaging for Smoking Cessation

December 14, 2018 updated by: Claire Spears, Georgia State University

iQuit Mindfully: A Randomized Controlled Trial of Mindfulness-based Smoking Cessation Enhanced With Mobile Technology

The purpose of this study is to investigate text messaging as a way to enhance mindfulness-based treatment for smoking cessation.

Study Overview

Detailed Description

This study is a pilot investigation of mindfulness-based smoking cessation treatment incorporating between-session text messaging ("iQuit Mindfully"). Participants will be randomly assigned to one of two groups: Mindfulness-based Addiction Treatment (MBAT) or iQuit Mindfully (MBAT with the addition of between-session text messages).

All participants will receive in-person group treatment based on the 8-week MBAT protocol in addition to nicotine patch therapy and self-help materials. Participants assigned to iQuit Mindfully will receive additional support via text messaging. Assessments will occur at baseline, at each of the weekly in-person visits, at end of treatment, and at 1-month follow-up. Feasibility, smoking abstinence, mindfulness practice, and indicators of tobacco dependence and psychological well-being will be assessed.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • 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

    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Georgia State University

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

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18-65 years
  • current smoker with history of >5 cigarettes/day for past year (and expired carbon monoxide >6 parts per million [ppm])
  • motivated to quit within next 30 days
  • valid home address in the greater Atlanta, Georgia area
  • functioning telephone number
  • own a mobile phone with text messaging capacity
  • can speak, read, and write in English
  • at least a sixth-grade level of health literacy

Exclusion Criteria:

  • contraindication for nicotine patch
  • active substance abuse/dependence
  • regular use of tobacco products other than cigarettes
  • current use of tobacco cessation medications
  • pregnancy or lactation
  • household member enrolled in the study
  • current diagnosis of schizophrenia or bipolar disorder, or use of antipsychotic medications
  • clinically significant depressive symptoms

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Mindfulness-based Addiction Treatment (MBAT)
Nicotine patch; self-help guide; MBAT
Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008).
Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
Other Names:
  • Generic Nicotine Patch
EXPERIMENTAL: iQuit Mindfully
Nicotine patch; self-help guide; MBAT; text messaging
iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
Other Names:
  • Mindfulness-based text messaging for smoking cessation
Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008).
Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
Other Names:
  • Generic Nicotine Patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking Abstinence
Time Frame: End of Treatment (8 weeks)
Number of participants who abstained from smoking (based on self-reported 7-day abstinence, which is biochemically verified by expired carbon monoxide <6 parts per million (ppm)
End of Treatment (8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Engagement
Time Frame: Over the 8-week treatment period
Number of participants who respond to interactive text messages
Over the 8-week treatment period
Participant Ratings
Time Frame: End of Treatment (8 weeks)
Perceived Text Message Helpfulness (minimum value 1 ["not at all helpful"], maximum value 10 ["extremely helpful"], higher scores mean better outcome)
End of Treatment (8 weeks)
Attrition
Time Frame: End of treatment (8 weeks)
Number of participants who do not attend end-of-treatment session
End of treatment (8 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Cigarettes Smoked Per Day
Time Frame: End of treatment (8 weeks)
Self-reported number of cigarettes smoked per day (questionnaire)
End of treatment (8 weeks)
Weekly Mindfulness Practice
Time Frame: Throughout treatment period (8 weeks)
Self-reported average weekly mindfulness practice (questionnaire)
Throughout treatment period (8 weeks)
Self-reported Mindfulness and Psychological Functioning
Time Frame: End of treatment (8 weeks)
Mindfulness, affect, self-efficacy, dependence, and withdrawal symptoms (questionnaire)
End of treatment (8 weeks)

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

January 18, 2017

Primary Completion (ACTUAL)

August 10, 2017

Study Completion (ACTUAL)

October 3, 2017

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 20, 2017

First Posted (ESTIMATE)

January 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 8, 2019

Last Update Submitted That Met QC Criteria

December 14, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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