Nudges for Smoking Cessation in Mental Illness

(ISRAISE Trial)

No longer recruiting at 1 trial location

Overseen By Aimee James, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Tobacco treatment

Disqualifiers: Active tobacco treatment

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals with serious mental illness quit smoking. It tests an approach called "Nudges to Quit," which includes reminders and support from a care team, such as case workers and pharmacists, to encourage quitting. Some participants will receive usual care, while others will get these additional nudges. Suitable candidates have a serious mental illness, smoke more than five cigarettes daily, and have not recently received tobacco treatment. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could develop new support methods for quitting smoking.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot participate if you have used tobacco treatment medications or counseling in the past 30 days.

What prior data suggests that the "Nudges to Quit" intervention is safe for smoking cessation in patients with serious mental illness?

Research has shown that nudges are generally safe and well-tolerated. In studies, these gentle reminders and prompts have helped people adopt healthier habits, such as quitting smoking. The goal is to encourage better choices in a supportive way.

Reports of harmful side effects from nudges do not exist. Instead, these methods aim to increase engagement with treatments safely, making them a low-risk option for helping people stop smoking. For those considering joining a trial that uses nudges, current evidence suggests they are safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Nudges to Quit" approach for smoking cessation in individuals with mental illness because it offers a unique way to enhance engagement with tobacco treatment. Unlike traditional methods that often rely on self-initiated quitting or pharmacotherapy like nicotine replacement therapies, this strategy employs reminders to the care team, creating a supportive network that actively encourages patients to quit smoking. This multilevel intervention aims to increase patient interaction with smoking cessation resources, potentially leading to better engagement and outcomes.

What evidence suggests that this trial's treatments could be effective for smoking cessation in mental illness?

Research has shown that "nudges," which participants in this trial may receive, can help adults reduce tobacco and alcohol use. In a study on smoking, these gentle reminders and prompts reduced smoking rates in some communities. This trial will compare the effectiveness of "Nudges to Quit," designed to increase participation in tobacco treatment, with Usual Care. By reminding both patients and their healthcare teams, nudges aim to support smoking cessation. Although promising, further studies are needed to confirm their effect on helping people with serious mental illness stop smoking. ^{6 7 8 9 10}

Who Is on the Research Team?

Li-Shiun Chen, M.D., MPH, ScD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are patients at a participating clinic, speak and understand English, and currently smoke more than five cigarettes per day. It's not for those actively using or prescribed smoking cessation medication in the past month.

Inclusion Criteria

Patient of participating clinic

Current smoker, >5 cigarettes per day

Can speak and understand English

Exclusion Criteria

Active use or receipt of tobacco treatment (medication or counseling) within the past 30 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

All patients receive a pre-appointment tobacco treatment needs assessment with patient input as decision support for their care team

1 week

1 visit (in-person)

Treatment

Patients are randomized to either usual care or the 'Nudges to Quit' intervention, with follow-up surveys at 3 and 6 months

6 months

3 visits (in-person)

Follow-up

Participants are monitored for smoking behaviors and treatment engagement after the intervention

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Nudges
• Usual Care

Trial Overview 'Nudges to Quit' is being tested as a way to help people with serious mental illness quit smoking by increasing engagement between patients, case workers, and pharmacists. This pilot study will inform a larger future trial.

How Is the Trial Designed?

Group I: "Nudges to Quit" Experimental Treatment 1 Intervention

Patients will receive a multilevel intervention that includes reminders to care team to increase tobacco treatment engagement.

Group II: Usual Care Active Control 1 Intervention

Patients will receive general brief advice about smoking cessation at patient tobacco treatment needs assessment then receive the intervention at 3 months.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9913966/

Nudging Interventions on Alcohol and Tobacco ... In conclusion, nudge strategies for tobacco and alcohol consumption prevention in adults show promising results.

2. sciencedirect.com sciencedirect.com/science/article/pii/S277272462500037X?via%3Dihub

A formative study to develop nudges informed by ... ... nudge design, a randomized clinical trial is needed to test the actual effectiveness of these nudges for improving patient engagement with tobacco treatment.

3. formative.jmir.org formative.jmir.org/2024/1/e52558

Nudges and Prompts Increase Engagement in Self-Guided ... This study was conducted on self-guided treatment for depression and anxiety, but it did not measure clinical outcomes. Although the study ...

4. researchprotocols.org researchprotocols.org/2022/8/e37231/

Testing Behavioral Nudges and Prompts in Digital Courses ... Our 3-arm randomized controlled trial will be the first to compare four distinct types of behavioral prompts and nudges in two self-guided digital health ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002%2Fhec.4509

Healthy, nudged, and wise: Experimental evidence on the ... We evaluate the performance of two behavioral interventions aimed at reducing tobacco consumption in an ultra-poor rural region of Bangladesh.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11234631/

Combining app-based behavioral therapy with electronic ... Secondary objectives are to examine within-group changes in smoking cessation-related and psychological outcomes, including urges to smoke, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0213911125000226

Healthy nudges: exploring their variability, limitations, and ... First, healthy nudges are generally effective, although there is considerable variability in their outcomes. Effectiveness compared to the control group ranges ...

8. researchgate.net researchgate.net/publication/393033786_A_Formative_Study_to_Develop_Nudges_Informed_by_Behavioral_Economics_to_Increase_Engagement_with_Tobacco_Treatment_among_People_who_Smoke_Receiving_Care_for_HIV

(PDF) A Formative Study to Develop Nudges Informed by ... This evaluation had 3 primary outcomes: 1) rates of smoking and tobacco use among program clients, 2) the percentage of clients who made a quit ...

9. withpower.com withpower.com/clinical-trials/for-smoking-cessation

Top Smoking Cessation Clinical Trials | Power This is a pilot trial to examine the feasibility and preliminary effect of a multilevel intervention 'Nudges to Quit' on smoking cessation in patients with ...

10. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/hec.4509

Healthy, nudged, and wise: Experimental evidence on the ... Our aim with this study is to add fresh evidence on the effectiveness and limitations of behavioral interventions aimed at promoting smoking ...