Clinical trial NCT04965181: Mindfulness-based Smoking Cessation Enhanced With Mobile Technology
Official title: 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: University of Chicago
name: University of Utah
name: George Washington University
name: National Cancer Institute (NCI)
First posted: 2021-07-16
Enrollment: 502
Sex: ALL
Minimum age (years): 18
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:

Aim I: Test the efficacy of a mindfulness-based text messaging program for smoking cessation ("iQuit Mindfully"), both as a standalone intervention and in combination with in-person counseling; and Aim II: Investigate the mechanisms through which mindfulness training impacts smoking cessation.

Detailed description: This study is a 2 X 2 randomized controlled trial to investigate the effects of the iQuit Mindfully text messaging program, both as a standalone intervention and in combination with in-person counseling (Mindfulness-based Addiction Treatment; MBAT), compared to usual care. Participants will be randomized to one of four groups based on assignment to iQuit Mindfully text messages (yes/no) and in-person MBAT (yes/no):

* Usual Care (self-help materials + nicotine patch and nicotine lozenge treatment)
* MBAT (8 weekly virtual MBAT sessions + self-help materials + nicotine patch and nicotine lozenge treatment)
* iQuit Mindfully (iQuit Mindfully text messages + self-help materials + nicotine patch and nicotine lozenge treatment)
* MBAT + iQuit Mindfully (8 weekly virtual MBAT sessions + iQuit Mindfully text messages + self-help materials + nicotine patch and nicotine lozenge treatment)

All study participants will receive self-help smoking cessation materials, including the "Clearing the Air" booklet developed by the National Cancer Institute (NCI) and a referral to the Tobacco Cessation Quitline (1-800-QUIT-NOW). All study participants will also receive nicotine patches and lozenges. Assessments will occur at baseline and weeks 1, 3, 5, and 8. Follow-up assessments will occur at weeks 12 and 24.

Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* current smoker with history of \>3 cigarettes/day (and expired carbon monoxide \[CO\] \>6ppm)
* motivated to quit within next 30 days
* valid home address in the greater Atlanta, GA area
* functioning telephone number
* can speak, read, and write in English

Exclusion Criteria:

* contraindication for nicotine patch or nicotine lozenge
* active substance abuse/dependence
* current suicidal ideation
* current use of tobacco cessation medications
* pregnancy, planning to become pregnant in the next 5 months, or lactation
* household member enrolled in the study
* enrolled in previous smoking cessation study based on mindfulness and/or text messaging at Georgia State University

Primary outcomes:
measure: Number of participants with confirmed smoking abstinence, 8 weeks
timeFrame: 8 weeks after the start of treatment
measure: Number of participants with confirmed smoking abstinence, 12 weeks
timeFrame: 12 weeks after the start of treatment
measure: Number of participants with confirmed smoking abstinence, 24 weeks
timeFrame: 24 weeks after the start of treatment
Secondary outcomes:
measure: Home mindfulness practice (number of days per week)
timeFrame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
measure: Dispositional mindfulness (Mindful Attention Awareness Scale [MAAS])
timeFrame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
measure: Dispositional mindfulness (Five Facet Mindfulness Questionnaire-Short Form [FFMQ-SF])
timeFrame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
measure: Self-compassion (Self-Compassion Scale-Short Form [SCS-SF])
timeFrame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
measure: Stress (Perceived Stress Scale [PSS])
timeFrame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
measure: Emotions (Positive and Negative Affect Schedule [PANAS])
timeFrame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
measure: Craving and withdrawal (Wisconsin Smoking Withdrawal Scale [WSWS])
timeFrame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
measure: Nicotine dependence (Brief Wisconsin Dependence Motives Questionnaire [WISDM])
timeFrame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
measure: Self-efficacy (Self-Efficacy Scale)
timeFrame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
measure: Social support (Multidimensional Scale of Perceived Social Support; higher scores mean better outcome; scores range 1-7)
timeFrame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
measure: Program evaluation (questionnaire developed for this study to evaluate participants' perceptions of the helpfulness of intervention components, the extent to which they would recommend the program to others, and suggestions for improvement)
timeFrame: 8 weeks after treatment
Other outcomes:
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: Spears CA, Mhende J, Hawkins C, Do VV, Hayat MJ, Eriksen MP, Hedeker D, Abroms LC, Wetter DW. Mindfulness-Based Smoking Cessation Delivered Through Telehealth and Text Messaging for Low-Income Smokers: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Aug 1;11(8):e35688. doi: 10.2196/35688.