Tobacco CessationNCT04367506
Pilot Testing a Digital Intervention to Improve Smoking Cessation in Persons With Serious Mental Illness
A study testing BecomeAnEX in people with Tobacco Cessation, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Cessation
- What is being tested?
- BecomeAnEX
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Sep 2022to 25 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or greater
- Diagnosis of serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder, or major depression)
- Current smoker [prior to admission, smoked at least one cigarette or small cigar per day in the past month (unless restricted, e.g. due to ER/hospital visit) and smoked at least 100 cigarettes lifetime]
- Interested in remaining quit after hospital discharge or quitting within the following 30 days
- Expected Internet use at least 3 times/week post-discharge and ownership of mobile device with text messaging plan post-discharge.
- Discharge destination within 1-hour of SPH given that Aim 3 involves biochemical verification (carbon monoxide testing).
- Reading competence as demonstrated by a score of >= 37 on the Word Reading subtest of the Wide Range Achievement Test - 4th Edition (WRAT-4)168 to ensure the ability to engage in the intervention.
Who cannot join
- Intellectual disability (DSM5 317, 318), traumatic brain injury, or deafness.
- Homeless prior to admission or anticipated to be homeless at discharge.
- Discharge to a residential setting where smoking is prohibited.
- Medical condition for which the use of nicotine replacement therapy (NRT) is contraindicated including pregnant, planning to become pregnant, or breastfeeding; within 4 weeks post myocardial infarction; severe arrhythmia, severe angina pectoris; peptic ulcer; severe renal failure; poorly controlled insulin-dependent diabetes; severely uncontrolled hypertension; peripheral vascular disease.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Melanie Bennett
Baltimore, Maryland, 21021
University of Maryland School of Medicine
Baltimore, Maryland, 21201
About this study
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.
Read the detailed description
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.
- Conditions
- Tobacco Cessation
- Being tested
- BecomeAnEX, Usual Care
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BecomeAnEXBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BecomeAnEX | Experimental | 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. Receives: Behavioral: BecomeAnEX; Behavioral: Usual Care |
| Usual Care | Active comparator | 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence
Self-report 7-day point prevalence abstinence
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start6 Sep 2022
- Primary completion25 Mar 2024
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomized controlled trial to examine indicators of feasibility, acceptability, target mechanisms, and preliminary efficacy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Sheppard Pratt Health System, Truth Initiative
- Responsible party
- Principal investigator, Melanie E Bennett, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367506
- Sponsor's protocol ID
- 1R34MH120142
- Status last verified
- Jun 2026
- First submitted
- 26 Apr 2020
- Last updated
- 15 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing a Digital Intervention to Improve Smoking Cessation in Persons With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT04367506
- Acronym / sponsor ID
- 1R34MH120142
- Conditions
- Tobacco Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Sheppard Pratt Health System, Truth Initiative
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Posted 15 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot randomized controlled trial to examine indicators of feasibility, acceptability, target mechanisms, and preliminary efficacy.
| Arm | Type | Receives |
|---|---|---|
| BecomeAnEX | Experimental | Behavioral: BecomeAnEX, Behavioral: Usual CareParticipants 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. |
| Usual Care | Active comparator | Behavioral: Usual CareBrief 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 or greater
- Diagnosis of serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder, or major depression)
- Current smoker [prior to admission, smoked at least one cigarette or small cigar per day in the past month (unless restricted, e.g. due to ER/hospital visit) and smoked at least 100 cigarettes lifetime]
- Interested in remaining quit after hospital discharge or quitting within the following 30 days
- Expected Internet use at least 3 times/week post-discharge and ownership of mobile device with text messaging plan post-discharge.
Key exclusion criteria (4 listed)
- Intellectual disability (DSM5 317, 318), traumatic brain injury, or deafness.
- Homeless prior to admission or anticipated to be homeless at discharge.
- Discharge to a residential setting where smoking is prohibited.
- Medical condition for which the use of nicotine replacement therapy (NRT) is contraindicated including pregnant, planning to become pregnant, or breastfeeding; within 4 weeks post myocardial infarction; severe arrhythmia, severe angina pectoris; peptic ulcer; severe renal failure; poorly controlled insulin-dependent diabetes; severely uncontrolled hypertension; peripheral vascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BecomeAnEXThis 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. | Behavioural | BecomeAnEX |
| Usual CareUsual 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. | Behavioural | BecomeAnEX, Usual Care |
Primary outcome
Smoking Abstinence
Time frame: 1 month
Self-report 7-day point prevalence abstinence
Craving
Time frame: 1 month
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.
Self-efficacy
Time frame: 1 month
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.
Abstinence-Related Motivational
Time frame: 1 month
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BecomeAnEX in people with Tobacco Cessation, run by University of Maryland, Baltimore at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Abstinence (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.