Feasibility and Efficacy of a Brief Mindfulness-Based Intervention SMOKING INTERVENTION VIA THE INTERNET

Substance Use Clinical Trial

Official title:

Feasibility and Efficacy of a Brief Mindfulness-Based Smoking Intervention Via the Internet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04572126
• Other study ID #: IRB-20-09-2668
• Status: Completed
• Phase: N/A
• Start date: November 25, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: February 2022
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study will examine both the feasibility and efficacy of a single session, web-based mindfulness-based intervention for smoking cessation. The study will explore (1) participants' subjective experiences of the intervention, (2) cravings and negative affect both before and after the intervention, and (3) changes in tobacco use one week and one month following the initial intervention. Further, the study will examine how often participants utilize the intervention between the initial study and follow-up periods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 1, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Daily Smoker
• Has a desire to quit or reduce smoking.
• Is not currently involved in another smoking reduction or cessation program. Exclusion Criteria: -

Related Conditions & MeSH terms

• Smoking Reduction
• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• Mindfulness Intervention
The mindfulness intervention includes strategies to cope with substance cravings based on previously published mindfulness techniques. Examples of strategies presented include paying close attention to sensations, acceptance of cravings, and self-kindness.
• Control Intervention
The control intervention instructs participants to utilize their own, previously used strategies to cope with substance cravings.

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bowen S, Marlatt A. Surfing the urge: brief mindfulness-based intervention for college student smokers. Psychol Addict Behav. 2009 Dec;23(4):666-71. doi: 10.1037/a0017127. — View Citation

Brewer JA, Mallik S, Babuscio TA, Nich C, Johnson HE, Deleone CM, Minnix-Cotton CA, Byrne SA, Kober H, Weinstein AJ, Carroll KM, Rounsaville BJ. Mindfulness training for smoking cessation: results from a randomized controlled trial. Drug Alcohol Depend. 2011 Dec 1;119(1-2):72-80. doi: 10.1016/j.drugalcdep.2011.05.027. Epub 2011 Jul 1. — View Citation

Witkiewitz K, Bowen S. Depression, craving, and substance use following a randomized trial of mindfulness-based relapse prevention. J Consult Clin Psychol. 2010 Jun;78(3):362-374. doi: 10.1037/a0019172. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Ratings Questionnaire	The participant's ratings of subjective likeability and helpfulness of the intervention. These ratings will be measured on a 5-point Likert Scale with higher scores representing more likeability and helpfulness. The 11-item questionnaire results in a score ranging from 11-55.	Immediately post-intervention
Primary	Change in Past Month Cigarette and E-Cigarette use.	An online version of the TLFB (Sobbel & Sobbel, 1992) will be used to measure past-month cigarette and e-cigarette use. The measure will be administered pre-intervention and one-month following the intervention to show change over time.	Immediately before the intervention and at one-month follow-up.
Primary	Change in Cigarette/E-cigarette Craving	Craving to smoke will be measured using the 10-item Brief Questionnaire of Smoking Urges (Cox, Tiffany, & Christen, 2001).While the QSU-brief can be scored by using all 10 items for one total craving score, maximum likelihood factor analysis of the QSU-brief revealed a two-factor model consisting of (1) a strong desire and intention to smoke with the perception of receiving positive rewards from smoking and (2) the expectation that smoking would relieve negative affect and the strong desire to smoke. The measure will be administered immediately preceding and following the intervention to show intervention influence on craving.	Immediately preceding and following intervention.
Primary	Change in Positive and Negative Affect	Positive and negative affect will be measured by the Positive and Negative Affect Schedule (Watson & Clark, 1999).	Immediately preceding and following intervention as well as at one-month follow-up.
Secondary	Intervention Use.	Number of times participants viewed intervention between intervention completion and one-month follow-up.	One-month after intervention.