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

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Reduction; Substance Use
• Intervention / Treatment: Behavioral: Mindfulness Intervention; Behavioral: Control Intervention

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Wayne State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Group; Participants in the mindfulness group will receive mindfulness based instructions.	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.
Active Comparator: Control Group; Participants in the control group will receive instructions to cope with cravings how they normally would.	Behavioral: Control Intervention; The control intervention instructs participants to utilize their own, previously used strategies to cope with substance cravings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Use.	Number of times participants viewed intervention between intervention completion and one-month follow-up.	One-month after intervention.

Collaborators and Investigators

• Sponsor: Wayne State University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Actual): July 20, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Smoking Reduction
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: IRB-20-09-2668

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No