An interventional study of BecomeAnEX and Usual Care in Tobacco Cessation, sponsored by University of Maryland, Baltimore. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Treatment
All patients with serious mental illness are abstinent while in the hospital for a psychiatric admission yet almost all return to smoking after discharge. The investigators propose to test a digital intervention adapted to the needs of SMI smokers and to being introduced in the inpatient psychiatric setting. Such an intervention could bridge the inpatient to outpatient gap in cessation services and will help people remain abstinent following hospital discharge.
Persons with serious mental illness (SMI) die on average 10-15 years earlier than those in the general population. Smoking is the strongest risk factor for their elevated mortality. Helping SMI smokers to quit is an urgent and unmet need. The hospital is an optimal setting to provide smoking cessation services. Hospital admissions for SMI are common with more than 1.2 million inpatient stays for schizophrenia and mood disorders per year in the US. Hospitalized patients experience required abstinence, are available for counseling, and can try cessation medications in a supportive setting. The challenge is how to engage SMI patients in cessation services post-discharge. An easy-to-access digital intervention is a scalable and sustainable way to bridge the inpatient-to-outpatient gap and to promote sustained abstinence. Digital interventions can deliver all elements of cessation treatment and yield quit rates comparable to face to face and telephonic interventions. SMI patients use and benefit from technology-based interventions but currently there is no digital smoking cessation program addressing their needs. In this study, the investigators tested a digital intervention adapted to the needs of SMI smokers and to being introduced in the inpatient psychiatric setting. The digital intervention, BecomeAnEX (EX), developed and run by Truth Initiative for over 10 years, includes real-time one on one coaching via live chat, nicotine replacement therapy decision support and delivery, personalized quit plans, a large online social network for peer support, a robust and fully integrated text message program, and tailored email messaging. SMI smokers recruited during psychiatric hospitalization will be randomized to usual care or to an adapted version of EX (EX-SMI) and followed for 3 months after the hospital stay. The investigators will compare the feasibility/acceptability of EX-SMI, measure intervention impact on target mechanisms, and obtain initial estimates of efficacy on 7-day point prevalence abstinence. Such an intervention could bridge the inpatient to outpatient gap in cessation services and will help people remain abstinent following hospital discharge.
62 studies on the registry are indexed under Tobacco Use Cessation; 31 are open to participants now.
This study's enrollment of 59 is below the median of 223 across 61 interventional studies indexed under Tobacco Use Cessation.
Browse Tobacco Use Cessation studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
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Exclusion Criteria:
Participants will have three individual meetings with a research staff person while they are in the hospital. At these meetings participants will answer questions about their smoking and interest in quitting, learn about BecomeAnEx, and register with the BecomeAnEx program so that they can use it when you leave the hospital. Participants will be given two weeks of nicotine replacement therapy when they leave the hospital. Participants will be asked to use BecomeAnEx as much as they want when they leave the hospital.
Behavioral: BecomeAnEX · Behavioral: Usual Care
Brief individual counseling, NRT during the hospital stay and a prescription for NRT at discharge (consistent with standard hospital procedures), and referral to the MD quitline.
Behavioral: Usual Care
This research study is focused on a smoking cessation program called BecomeAnEx. We are studying how to adapt BecomeAnEx for people with a mental health disorder who want to reduce or quit their tobacco smoking. BecomeAnEx includes a website that provides education about smoking and quitting. It also has a text messaging program that delivers personalized information. Persons in the program have access to real-time digital coaching with a remote coach who has experience helping people quit smoking. In addition, the program has an on-line community of current and former smokers that can provide support and encouragement.
Usual care represents what hospitalized psychiatric patients normally receive in terms of smoking cessation: brief individual counseling, NRT during the hospital stay and a prescription for NRT at discharge (consistent with standard hospital procedures), and referral to the MD quitline.
Smoking Abstinence
Self-report 7-day point prevalence abstinence
Time frame: 1 month
Craving
Craving was assessed with 11 items from the Tobacco Cravings Questionnaire (TCQ). Possible scores range from 11-77, with higher scores indicating greater tobacco craving.
Time frame: 1 month
Self-efficacy
The 9-item Abstinence Self-Efficacy Questionnaire (ASEQ) measured confidence to resist smoking across situations and emotional states. Possible scores range from 9-45, with higher scores indicating greater abstinence self-efficacy.
Time frame: 1 month
Abstinence-Related Motivational
The 16-item Abstinence-Related Motivational Engagement (ARME) assessed motivation to maintain smoking abstinence. Possible scores range from 16-112, with higher scores indicating greater abstinence-related motivation.
Time frame: 1 month
The trial took place at two inpatient psychiatry units within a Mid-Atlantic hospital system.
| Milestone | BecomeAnEX | Usual Care |
|---|---|---|
| Started | 38 | 20 |
| Started condition | 31 | 17 |
| Completed 1 month assessment | 17 | 7 |
| Completed 3 month assessment | 11 | 6 |
| Completed | 11 | 6 |
| Not completed | 27 | 14 |
| Withdrew: Withdrawal by subject | 7 | 5 |
| Withdrew: Lost to follow-up | 20 | 9 |
Self-report 7-day point prevalence abstinence
| Participants | BecomeAnEX | Usual Care |
|---|---|---|
| Smoking Abstinence | 6 | 0 |
Craving was assessed with 11 items from the Tobacco Cravings Questionnaire (TCQ). Possible scores range from 11-77, with higher scores indicating greater tobacco craving.
| Scores on a scale | BecomeAnEX | Usual Care |
|---|---|---|
| Craving | 35.3 ± 21.4 | 47.7 ± 16.0 |
The 9-item Abstinence Self-Efficacy Questionnaire (ASEQ) measured confidence to resist smoking across situations and emotional states. Possible scores range from 9-45, with higher scores indicating greater abstinence self-efficacy.
| Scores on a scale | BecomeAnEX | Usual Care |
|---|---|---|
| Self-efficacy | 28.8 ± 11.3 | 28.9 ± 9.2 |
The 16-item Abstinence-Related Motivational Engagement (ARME) assessed motivation to maintain smoking abstinence. Possible scores range from 16-112, with higher scores indicating greater abstinence-related motivation.
| Scores on a scale | BecomeAnEX | Usual Care |
|---|---|---|
| Abstinence-Related Motivational | 87.9 ± 15.2 | 74.1 ± 17.7 |
Collected over 3 months per participant, 18 months for the study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BecomeAnEX | 0/38 (0%) | 7/38 (18.4%) | 4/38 (10.5%) |
| Usual Care | 0/20 (0%) | 4/20 (20%) | 3/20 (15%) |
| Event | BecomeAnEX | Usual Care |
|---|---|---|
| Medical or psychiatric hospitalization of any durationPsychiatric disorders | 7/38 | 4/20 |
| Event | BecomeAnEX | Usual Care |
|---|---|---|
| Emergency room visits for a medical or psychiatric reason that did not result in hospitalization.Psychiatric disorders | 4/38 | 3/20 |
The trial took place at two inpatient psychiatry units within a Mid-Atlantic 12-hospital system. The participants enrolled in Aims 1 and 2 did not provide Primary or Secondary Outcome Measures. For the Aim 3 pilot trial, participants were recruited between September 6, 2022, and March 25, 2024.
| Age, Continuous(years) | BecomeAnEX | Usual Care | Total |
|---|---|---|---|
| Mean | 42.3 ± 11.8 | 37.4 ± 11.6 | 40.5 ± 11.9 |
| Sex: Female, Male(Participants) | BecomeAnEX | Usual Care | Total |
|---|---|---|---|
| Female | 21 | 12 | 33 |
| Male | 17 | 8 | 25 |
| Race/Ethnicity, Customized(Participants) | BecomeAnEX | Usual Care | Total |
|---|---|---|---|
| Ethnicity - Hispanic or Latino | 4 | 4 | 8 |
| Ethnicity - Not Hispanic or Latino | 34 | 16 | 50 |
| Race - Black | 18 | 11 | 29 |
| Race - White | 15 | 5 | 20 |
| Race - Multiple Race or Other | 5 | 4 | 9 |
| Age at onset of regular smoking (years)(years) | BecomeAnEX | Usual Care | Total |
|---|---|---|---|
| Mean | 17.2 ± 5.1 | 16.7 ± 3.2 | 17.1 ± 4.5 |
| Cigarettes per day at admission(number of cigarettes per day) | BecomeAnEX | Usual Care | Total |
|---|---|---|---|
| Mean | 13.9 ± 8.1 | 12.6 ± 8.5 | 13.4 ± 8.2 |
| Heaviness of Smoking Index (HSI)(HSI total score) | BecomeAnEX | Usual Care | Total |
|---|---|---|---|
| Mean | 2.6 ± 1.5 | 2.5 ± 1.5 | 2.6 ± 1.5 |
| Tobacco Craving Questionnaire (TCQ)(TCQ total score) | BecomeAnEX | Usual Care | Total |
|---|---|---|---|
| Mean | 40.1 ± 16.8 | 47.6 ± 22.2 | 42.7 ± 19.0 |
| Smoking Abstinence Self-Efficacy (ASEQ)(ASEQ total score) | BecomeAnEX | Usual Care | Total |
|---|---|---|---|
| Mean | 25.1 ± 9.3 | 29.6 ± 10.7 | 26.7 ± 9.9 |
1 further baseline measures are reported on the registry.
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore