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

Sponsor
Wayne State University (Other)
Overall Status
Completed
CT.gov ID
NCT04572126
Collaborator
(none)
80
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness Intervention
  • Behavioral: Control Intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are randomly assigned to either the mindfulness intervention group or control group.Participants are randomly assigned to either the mindfulness intervention group or control group.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Feasibility and Efficacy of a Brief Mindfulness-Based Smoking Intervention Via the Internet
Actual Study Start Date :
Nov 25, 2020
Actual Primary Completion Date :
Jul 20, 2021
Actual Study Completion Date :
Aug 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Subjective Ratings Questionnaire [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. [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 [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 [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 Outcome Measures

  1. Intervention Use. [One-month after intervention.]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wayne State University Detroit Michigan United States 48202

Sponsors and Collaborators

  • Wayne State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Michael Schmidt, Principal Investigator, Wayne State University
ClinicalTrials.gov Identifier:
NCT04572126
Other Study ID Numbers:
  • IRB-20-09-2668
First Posted:
Oct 1, 2020
Last Update Posted:
Mar 11, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michael Schmidt, Principal Investigator, Wayne State University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2022