Clinical trial NCT03029819: iQuit Mindfully: Text Messaging for Smoking Cessation
Official title: iQuit Mindfully: A Randomized Controlled Trial of Mindfulness-based Smoking Cessation Enhanced With Mobile Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: University of Utah
name: The Catholic University of America
name: George Washington University
name: University of Chicago
First posted: 2017-01-24
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Smoking Abstinence
timeFrame: End of Treatment (8 weeks)
Secondary outcomes:
measure: Participant Engagement
timeFrame: Over the 8-week treatment period
measure: Participant Ratings
timeFrame: End of Treatment (8 weeks)
measure: Attrition
timeFrame: End of treatment (8 weeks)
Other outcomes:
measure: Number of Cigarettes Smoked Per Day
timeFrame: End of treatment (8 weeks)
measure: Weekly Mindfulness Practice
timeFrame: Throughout treatment period (8 weeks)
measure: Self-reported Mindfulness and Psychological Functioning
timeFrame: End of treatment (8 weeks)
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
Study officials:
affiliation: Georgia State University
name: Claire A Spears, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vidrine JI, Spears CA, Heppner WL, Reitzel LR, Marcus MT, Cinciripini PM, Waters AJ, Li Y, Nguyen NT, Cao Y, Tindle HA, Fine M, Safranek LV, Wetter DW. Efficacy of mindfulness-based addiction treatment (MBAT) for smoking cessation and lapse recovery: A randomized clinical trial. J Consult Clin Psychol. 2016 Sep;84(9):824-838. doi: 10.1037/ccp0000117.
citation: 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.
citation: Spears CA, Abroms LC, Glass CR, Hedeker D, Eriksen MP, Cottrell-Daniels C, Tran BQ, Wetter DW. Mindfulness-Based Smoking Cessation Enhanced With Mobile Technology (iQuit Mindfully): Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 24;7(6):e13059. doi: 10.2196/13059.