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

Study Overview
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Brief Summary
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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.

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

Conditions
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Substance Use, Smoking Reduction

Intervention / Treatment
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* Behavioral: Mindfulness Intervention
* Behavioral: Control Intervention


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly assigned to either the mindfulness intervention group or control group.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Reduction