iQuit Mindfully: Text Messaging for Smoking Cessation

Cigarette Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03029819
• Other study ID #: K23AT008442
• Secondary ID: K23AT008442
• Status: Completed
• Phase: N/A
• Start date: January 18, 2017
• Est. completion date: October 3, 2017

Study information

• Verified date: December 2018
• Source: Georgia State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 3, 2017
• Est. primary completion date: August 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• Mindfulness-based Addiction Treatment
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
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.
• Self-Help guide
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).

Drug:
• Nicotine Patch
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.

Locations

Country	Name	City	State
United States	Georgia State University	Atlanta	Georgia

Sponsors (6)

Lead Sponsor	Collaborator
Georgia State University	George Washington University, National Center for Complementary and Integrative Health (NCCIH), The Catholic University of America, University of Chicago, University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (2)

Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009. Review. — View Citation

Wetter, D. W., Vidrine, J. I., Fine, M., Rowan, P. J., Reitzel, L. R., & Tindle, H. (2009). Mindfulness- Based Addiction Treatment (MBAT) Manual.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Cigarettes Smoked Per Day	Self-reported number of cigarettes smoked per day (questionnaire)	End of treatment (8 weeks)
Other	Weekly Mindfulness Practice	Self-reported average weekly mindfulness practice (questionnaire)	Throughout treatment period (8 weeks)
Other	Self-reported Mindfulness and Psychological Functioning	Mindfulness, affect, self-efficacy, dependence, and withdrawal symptoms (questionnaire)	End of treatment (8 weeks)
Primary	Smoking Abstinence	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	Participant Engagement	Number of participants who respond to interactive text messages	Over the 8-week treatment period
Secondary	Participant Ratings	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)
Secondary	Attrition	Number of participants who do not attend end-of-treatment session	End of treatment (8 weeks)