Back to resultsFeasibility and Efficacy of a Brief Mindfulness-Based Intervention SMOKING INTERVENTION VIA THE INTERNET
Primary Purpose
Substance Use, Smoking Reduction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Intervention
Control Intervention
Sponsored by
About this trial
This is an interventional health services research trial for Substance Use focused on measuring Smoking Reduction
Eligibility Criteria
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:
-
Sites / Locations
- Wayne State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness Group
Control Group
Arm Description
Participants in the mindfulness group will receive mindfulness based instructions.
Participants in the control group will receive instructions to cope with cravings how they normally would.
Outcomes
Primary Outcome Measures
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.
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.
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.
Change in Positive and Negative Affect
Positive and negative affect will be measured by the Positive and Negative Affect Schedule (Watson & Clark, 1999).
Secondary Outcome Measures
Intervention Use.
Number of times participants viewed intervention between intervention completion and one-month follow-up.
Full Information
NCT ID
NCT04572126
First Posted
September 21, 2020
Last Updated
February 23, 2022
Sponsor
Wayne State University
1. Study Identification
Unique Protocol Identification Number
NCT04572126
Brief Title
Feasibility and Efficacy of a Brief Mindfulness-Based Intervention SMOKING INTERVENTION VIA THE INTERNET
Official Title
Feasibility and Efficacy of a Brief Mindfulness-Based Smoking Intervention Via the Internet
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
July 20, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Smoking Reduction
Keywords
Smoking Reduction
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to either the mindfulness intervention group or control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Group
Arm Type
Experimental
Arm Description
Participants in the mindfulness group will receive mindfulness based instructions.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants in the control group will receive instructions to cope with cravings how they normally would.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Intervention
Intervention Description
The control intervention instructs participants to utilize their own, previously used strategies to cope with substance cravings.
Primary Outcome Measure Information:
Title
Subjective Ratings Questionnaire
Description
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.
Time Frame
Immediately post-intervention
Title
Change in Past Month Cigarette and E-Cigarette use.
Description
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.
Time Frame
Immediately before the intervention and at one-month follow-up.
Title
Change in Cigarette/E-cigarette Craving
Description
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.
Time Frame
Immediately preceding and following intervention.
Title
Change in Positive and Negative Affect
Description
Positive and negative affect will be measured by the Positive and Negative Affect Schedule (Watson & Clark, 1999).
Time Frame
Immediately preceding and following intervention as well as at one-month follow-up.
Secondary Outcome Measure Information:
Title
Intervention Use.
Description
Number of times participants viewed intervention between intervention completion and one-month follow-up.
Time Frame
One-month after intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20025372
Citation
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.
Results Reference
background
PubMed Identifier
21723049
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.
Results Reference
background
PubMed Identifier
20515211
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.
Results Reference
background
Learn more about this trial
Feasibility and Efficacy of a Brief Mindfulness-Based Intervention SMOKING INTERVENTION VIA THE INTERNET
We'll reach out to this number within 24 hrs