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Completed

NCT Number: NCT03029819

iQuit Mindfully: Text Messaging for Smoking Cessation

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

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Key information

Conditions

Cigarette Smoking Behavior Smoking Tobacco Smoking Tobacco Use

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia State University

Atlanta, Georgia, 30303, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Mindfulness-based Addiction Treatment

Behavioral

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).

iQuit Mindfully

Behavioral

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

Self-help guide

Behavioral

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).

Nicotine patch

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Participant Engagement

    Time frame: Over the 8-week treatment period

    Number of participants who respond to interactive text messages

  2. 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)

  3. Attrition

    Time frame: End of treatment (8 weeks)

    Number of participants who do not attend end-of-treatment session

Other outcomes

  1. Number of Cigarettes Smoked Per Day

    Time frame: End of treatment (8 weeks)

    Self-reported number of cigarettes smoked per day (questionnaire)

  2. Weekly Mindfulness Practice

    Time frame: Throughout treatment period (8 weeks)

    Self-reported average weekly mindfulness practice (questionnaire)

  3. Self-reported Mindfulness and Psychological Functioning

    Time frame: End of treatment (8 weeks)

    Mindfulness, affect, self-efficacy, dependence, and withdrawal symptoms (questionnaire)

Sponsors and collaborators

Lead sponsor

Georgia State University

Other

Collaborators

  • George Washington University
  • National Center for Complementary and Integrative Health (NCCIH)
  • The Catholic University of America
  • University of Chicago
  • University of Utah

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 24, 2017
Registry last updated
Jan 8, 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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