Mindful Breaths: Mindfulness for Young Adult Vaping

Not Applicable

Not yet recruiting

• Conditions: Vaping Cessation
• Interventions: Behavioral: Guided mindfulness meditation; Behavioral: Scenery video

• Registration Number: NCT06626529
• Lead Sponsor: Tulane University

Brief Summary

The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary efficacy of mindfulness-based interventions (MBI) as a vaping cessation intervention in young adults aged 18-29 who vape nicotine at least 25 days per month and are interested in cutting down or quitting. The main questions it aims to answer are:

* Can mindfulness practice reduce nicotine cravings in young adults?

* Is mindfulness practice an acceptable and feasible intervention for vaping cessation in this population?

Researchers will compare participants in the mindfulness intervention group to a control group that watches a video with calming music and images to see if mindfulness practice has a greater effect on reducing nicotine cravings.

Participants will:

* Complete a baseline survey and craving cue reactivity assessment.

* Engage in a 10-minute guided mindfulness meditation (intervention group) or view calming music and images (control group).

* Rate their cravings and the acceptability, appropriateness, and feasibility of the intervention after the session.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-29
• Status Verified: 2024-10
• Study Start: 2024-10
• Study First Submitted QC: 2024-10-01
• Last Update Submitted: 2024-10-01
• Study First Posted: 2024-10-04
• Last Update Posted: 2024-10-04
• Primary Completion: 2025-03
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Young adults aged 18-29 years old
• Residing in the United States
• Able to read and speak English
• Vape nicotine at least 25 days/month,
• Interested in cutting down or quitting vaping in the next 30 days (rated at least a 5 on a 10-point scale).

Exclusion Criteria

• Using any nicotine-containing products other than e-cigarettes
• A current or past Diagnostic and Statistical Manual of Mental Disorders (DSM-5) psychiatric diagnosis of severe mental illness
• A current DSM diagnosis of substance use disorders other than tobacco use disorder
• Involved in regular mindful practice
• Undergoing current smoking/vaping cessation treatment (counseling and/or medication)
• Taking any medications that may potentially affect nicotine craving, consumption, or mood within the past 30 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness	Guided mindfulness meditation	Intervention group participants will practice mindfulness following a ten-minute video of guided mindfulness meditation for craving and addiction.
Scenery video	Scenery video	Control group participants will watch a ten-minute video of calming music and images.

Primary Outcome Measures

Name	Time	Method
Satisfaction	Within ten minutes after the completion of a single 10-minute guided meditation session	Satisfaction with the mindfulness intervention will be rated on a scale of 1-5, with a higher score indicating higher satisfaction.
Intervention appeal	Within ten minutes after the completion of a single 10-minute guided meditation session	Intervention appeal will be rated on a scale of 1-5, with a higher score indicating greater appeal.
Intervention appropriateness	Within ten minutes after the completion of a single 10-minute guided meditation session	Intervention appropriateness will be rated on a scale of 1-5, with a higher score indicating greater appropriateness.
Intervention feasibility	Within ten minutes after the completion of a single 10-minute guided meditation session	Intervention feasibility will be rated on a scale of 1-5, with a higher score indicating higher feasibility.
Perceived effectiveness	Within ten minutes after the completion of a single 10-minute guided meditation session	Perceived intervention effectiveness will be rated on a scale of 1-5, with a higher score indicating greater effectiveness.
Likelihood to continue mindfulness practice	Within ten minutes after the completion of a single 10-minute guided meditation session	The likelihood of continuing the mindfulness practice will be rated on a scale of 1-5, with a higher score indicating a higher likelihood of continuing the mindfulness practice.

Secondary Outcome Measures

Name	Time	Method
Craving	Within 20 minutes before and after a ten minute guided mindfulness meditation practice.	Craving for e-cigarettes will be measured with the adapted Visual Analog Craving Scale before and after each cue and the intervention/control to assess their craving intensity. Participants rate craving intensity by selecting a position along a line anchored on the left by "not at all" and on the right by "more than ever."