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

NCT04572126 | Completed

• 1 other identifier: IRB-20-09-2668
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Substance Use; Smoking Reduction

Keywords

Smoking Reduction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Intervention Use.

  One-month after intervention.

Study Arms (2)

Mindfulness Group

EXPERIMENTAL

Participants in the mindfulness group will receive mindfulness based instructions.

Behavioral: Mindfulness Intervention

Control Group

ACTIVE COMPARATOR

Participants in the control group will receive instructions to cope with cravings how they normally would.

Behavioral: Control Intervention

Interventions

Mindfulness Intervention BEHAVIORAL

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.

Mindfulness Group

Control Intervention BEHAVIORAL

The control intervention instructs participants to utilize their own, previously used strategies to cope with substance cravings.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

Related 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.

  PMID: 20025372 BACKGROUND

• 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.

  PMID: 21723049 BACKGROUND

• 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.

  PMID: 20515211 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders; Smoking Reduction

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior; Smoking

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomly assigned to either the mindfulness intervention group or control group.

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: October 1, 2020
• Study Start: November 25, 2020
• Primary Completion: July 20, 2021
• Study Completion: August 1, 2021
• Last Updated: March 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)