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Completed

NCT Number: NCT04572126

Feasibility and Efficacy of a Brief Mindfulness-Based Intervention 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wayne State University

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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.

Control Intervention

Behavioral

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

Primary outcomes

  1. Subjective Ratings Questionnaire

    Time frame: Immediately post-intervention

    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.

  2. Change in Past Month Cigarette and E-Cigarette use.

    Time frame: Immediately before the intervention and at one-month follow-up.

    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.

  3. Change in Cigarette/E-cigarette Craving

    Time frame: Immediately preceding and following intervention.

    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.

  4. Change in Positive and Negative Affect

    Time frame: Immediately preceding and following intervention as well as at one-month follow-up.

    Positive and negative affect will be measured by the Positive and Negative Affect Schedule (Watson & Clark, 1999).

Secondary outcomes

  1. Intervention Use.

    Time frame: One-month after intervention.

    Number of times participants viewed intervention between intervention completion and one-month follow-up.

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 1, 2020
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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