MTM-Based Program for Cigarette Smoking

Overseen By Refat Rasul Srejon, MBBS, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Nevada, Las Vegas

Disqualifiers: Non-cigarette tobacco, Pregnancy, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a new program can help young adults quit smoking more effectively than standard health education. It employs a unique approach called the Multi-Theory Model to boost confidence and transform emotions, with sessions held online. Eligible participants are young adults aged 18-29 in the U.S. who smoke daily but do not use other tobacco products. The trial will compare two groups: one follows the MTM-Based Smoking Cessation Program, while the other receives standard smoking information. If successful, this approach could provide a better way to support young adults in quitting smoking. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could transform smoking cessation strategies for young adults.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on smoking cessation and does not mention any medication restrictions.

What prior data suggests that this MTM-based behavioral intervention is safe for young adult smokers?

Research has shown that the Multi-Theory Model (MTM)-based program helps people quit smoking by changing their behaviors. Studies indicate that this approach can be effective. The program employs methods such as boosting confidence, providing emotional support, and creating a positive environment.

Without the use of drugs or medications, concerns about side effects are reduced. The focus on behavior makes it generally safe for participants. Participants in similar programs have not reported serious side effects, making it a well-tolerated option for those wanting to quit smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MTM-Based Smoking Cessation Program because it introduces a fresh approach to quitting smoking by focusing on the Multi-Theory Model (MTM) of health behavior change. Unlike traditional programs that primarily provide information on health risks and quitting techniques, this program emphasizes participatory dialogue, building behavioral confidence, and emotional transformation. It also includes interactive elements like storytelling, role-playing, and developing supportive social networks, making it a more engaging and personalized experience. This innovative approach aims to not only inform but also transform participants' attitudes and behaviors towards smoking cessation, potentially leading to more successful and lasting results.

What evidence suggests that this MTM-based program is effective for smoking cessation?

Research has shown that a program based on the Multi-Theory Model (MTM) might help young adults quit smoking. In this trial, participants in the MTM-Based Smoking Cessation Intervention arm will engage with strategies designed to boost confidence and emotional readiness, both crucial for quitting. This approach emphasizes habit change and the creation of supportive environments, leading to improved outcomes. Participants in previous studies often reported improved management of withdrawal symptoms, suggesting that the MTM-based program could effectively support smoking cessation efforts. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for young adult smokers aged 18 to 29 in the U.S. who want to quit smoking. Participants must be willing to complete surveys and attend virtual sessions. Those with a stable internet connection and understanding of English are ideal candidates.

Inclusion Criteria

Current smoker (defined as having smoked at least one cigarette daily over the past 7 days)

I am between 18 and 29 years old.

Resident of the United States

Exclusion Criteria

Participation in any other smoking cessation program

Use of non-cigarette tobacco products (e.g., vaping, smokeless tobacco)

Pregnant or planning to become pregnant during the study period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants attend four weekly 90-minute virtual sessions focusing on MTM constructs or knowledge-based smoking education

4 weeks

4 virtual sessions

Post-Intervention Assessment

Participants complete surveys to assess MTM construct scores, FTND, and quit rates

1 week

1 virtual survey

Follow-up

Participants are monitored for smoking cessation outcomes and MTM construct changes

12 weeks

1 virtual survey

What Are the Treatments Tested in This Trial?

Interventions

• MTM-Based Smoking Cessation Program

Trial Overview The study tests if a Multi-Theory Model (MTM)-based program helps young adults stop smoking better than standard education. It includes weekly online group sessions on behavior change strategies, with follow-ups at weeks 5 and 12.

How Is the Trial Designed?

Group I: Multi-Theory Model-Based Smoking Cessation Intervention Experimental Treatment 1 Intervention

This arm delivers a four-week smoking cessation intervention grounded in the Multi-Theory Model (MTM) of health behavior change. Participants are individually randomized into two arms of the study to ensure comparability between groups and reduce selection bias. The intervention comprises weekly 90-minute sessions delivered entirely online, with a focus on core MTM constructs: participatory dialogue, behavioral confidence, emotional transformation, practice for change, and changes in physical and social environment. Session activities include storytelling, interactive discussions weighing quitting pros and cons, confidence-building exercises, role-playing high-risk situations, emotional expression and transformation techniques, development of supportive social networks, stress management tools, reflection and reward practices, and commitment reinforcement through letters and group sharing.

Group II: Knowledge-Based Smoking Risk Education and Quit Strategies Active Control 1 Intervention

Participants are individually randomized to the control arm receive a four-week educational program focusing on basic information about the health risks of smoking and effective quitting techniques. The program consists of weekly 90-minute sessions delivered in an online format to maximize participant reach and accessibility. Sessions cover topics such as smoking-related health consequences, benefits of quitting, common barriers to cessation, and practical strategies for quitting smoking. Unlike the experimental arm, this program does not include behavior change techniques grounded in the Multi-Theory Model but instead emphasizes increasing awareness and knowledge to motivate cessation. This active comparator arm serves to control for time and attention while providing participants with standard smoking cessation information.

Who Is Running the Clinical Trial?

University of Nevada, Las Vegas

Lead Sponsor

Trials

81

Recruited

14,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6487755/

Utilizing Multi-Theory Model in Determining Intentions to ... The purpose of this study was to predict initiation and sustenance of smoking cessation among smokers using a fourth-generation behavioral framework, multi- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07104006

Smoking Cessation Intervention for Young Adults Using ... The goal of this clinical trial is to evaluate whether a Multi-Theory Model (MTM)-based behavioral intervention can effectively promote smoking cessation ...

3. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1472498/full

Applying multi-theory model to determine intentions ... Increased self-efficacy to quit and perceived control over withdrawal symptoms predict smoking cessation following nicotine dependence treatment. Addict ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5350547/

Applying a new theory to smoking cessation: case of multi- ... A fourth generation approach using multi-theory model (MTM) of health behavior change is introduced in this article for smoking cessation.

5. medrxiv.org medrxiv.org/content/10.1101/2024.02.22.24303218v1.full-text

Applying Multi-Theory Model (MTM) in Determining ... Smoking cessation behavior can be assessed using MTM both at the initiation and maintenance stages. It is important to develop future ...

6. journals.lww.com journals.lww.com/ijdr/fulltext/2021/32010/effectiveness_of_tobacco_cessation_counselling_and.13.aspx

Effectiveness of Tobacco Cessation Counselling and... The aim of the present study was to evaluate the effectiveness of tobacco cessation counselling and behavioural changes using Multi Theory Model (MTM).