An interventional study of Mindfulness with Contingency Management and Active Control in Smoking Cessation, sponsored by Fordham University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-15.
Sponsored by Fordham University · Not applicable, Interventional, and Treatment
This study aims to develop a Mindfulness Smartphone Intervention with Contingency Management (MSI-CM) for smoking cessation that can be readily available to depressed smokers receiving outpatient psychiatric treatment. This project is expected to result in the development of an effective intervention that will produce preliminary data showing increased short-term cessation success in depressed smokers receiving outpatient psychiatric treatment. It is anticipated that this smoking cessation intervention will have potential for broad reach to outpatient psychiatric treatment programs and have a significant overall impact in reducing smoking-related morbidity and mortality by enhancing smoking cessation rates in at-risk populations.
The proposed study will develop a Mindfulness Smartphone Intervention with Contingency Management (MSI-CM) for smoking cessation that can be readily available to depressed smokers receiving outpatient psychiatric treatment. The intervention will involve a series of brief mindfulness training that will be delivered via smartphone, that prompts patients to practice a mindfulness exercise multiple times a day while abstinent: 1) 10-days prior to their target quit date and 2) during the 2-week incentivized abstinence period (using CM) plus an additional 2 weeks (without CM) following their target quit date. We will use CM as an adjunct strategy to enhance the efficacy of mindfulness training due to its utility in producing short-term abstinence, so as to provide opportunities to practice mindfulness without smoking in one's natural environment. We will accomplish this objective by pursuing the following specific aims (in 2 phases):
Phase 1: To develop the MSI-CM intervention intended to improve smoking cessation success among depressed smokers receiving outpatient psychiatric treatment.
1a. We will collaborate with TelASK, Inc. to develop a prototype of a smartphone intervention (MSI-CM).
1b. We will conduct preliminary pilot testing of MSI-CM, in an iterative fashion, with 10 smokers receiving outpatient psychiatric treatment for depression.
Phase 2: To conduct a preliminary, randomized controlled trial (RCT) with depressed 60 smokers receiving outpatient psychiatric treatment.
Fordham University is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The intervention (MSI-CM) will involve two individual pre-quit in-person sessions and two post-quit phone counseling sessions, a series of brief mindfulness trainings that will be delivered via smartphone, that prompts participants to practice a mindfulness exercise five times a day while abstinent during the 2-week incentivized abstinence period (using CM) plus an additional 2 weeks (without CM) following the participant's target quit date. The MSI-CM participants will be asked to provide CO video via smartphone twice daily with monetary incentives provided (CM). Participants will receive monetary incentives contingent on each confirmed CO level (less than 7 ppm) for the CM period. We will use CM as an adjunct strategy to enhance the efficacy of mindfulness training.
Behavioral: Mindfulness with Contingency Management
Participants assigned to the control group will receive two individual pre-quit in-person sessions and two post-quit phone counseling sessions, similar to the MSI-CM except for mindfulness introduction/discussion. Participants in the control group will receive the same monetary incentives on average as the participants in the MSI-CM for submitting CO videos, regardless of CO levels (non-abstinent contingent), during the 2-week post-TQD period. Each participant in the group (the non-contingent CO group) will be yoked to a single participant (selected randomly with stratification) in the MSI-CM. The yoked participant receives the same amount of monetary incentives as his or her matched participant in the contingent CO (MSI-CM) group.
Behavioral: Active Control
Smoking Status
Self-reports of smoking status and verification via CO will be collected at 2-week, 4-week, and 3-month (cotinine level) post-target quit date assessment. The main outcome analyses are based upon 7-day point prevalence abstinence (PPA). As a secondary approach, we will use the timeline followback (TLFB) procedure for assessing the longitudinal course of smoking outcomes. Our approach permits us to follow the standard NCI and NHLBI guidelines for measurement. Biochemical Verification. Self-reported abstinence will be verified by carbon monoxide (CO) analysis of breath samples (6 ppm cutoff) for abstinence of 24 hours to one week for 3-month follow-up. Values above the cutoff will be considered indicative of smoking.
Time frame: 2-week, 4-week, and 3-month post-target quit date assessment visit
Plan to share: Undecided
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Fordham University