Trial Outcomes & Findings for Pilot Testing a Digital Intervention to Improve Smoking Cessation in Persons With Serious Mental Illness (NCT NCT04367506)
NCT ID: NCT04367506
Last Updated: 2026-07-15
Results Overview
Self-report 7-day point prevalence abstinence
COMPLETED
NA
59 participants
1 month
2026-07-15
Participant Flow
The trial took place at two inpatient psychiatry units within a Mid-Atlantic hospital system.
Participant milestones
| Measure |
BecomeAnEX
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.
BecomeAnEX: 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: 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.
|
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.
Usual Care: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
20
|
|
Overall Study
Started Condition
|
31
|
17
|
|
Overall Study
Completed 1 Month Assessment
|
17
|
7
|
|
Overall Study
Completed 3 Month Assessment
|
11
|
6
|
|
Overall Study
COMPLETED
|
11
|
6
|
|
Overall Study
NOT COMPLETED
|
27
|
14
|
Reasons for withdrawal
| Measure |
BecomeAnEX
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.
BecomeAnEX: 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: 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.
|
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.
Usual Care: 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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
|
Overall Study
Lost to Follow-up
|
20
|
9
|
Baseline Characteristics
Pilot Testing a Digital Intervention to Improve Smoking Cessation in Persons With Serious Mental Illness
Baseline characteristics by cohort
| Measure |
BecomeAnEX
n=38 Participants
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.
BecomeAnEX: 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: 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.
|
Usual Care
n=20 Participants
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.
Usual Care: 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.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 11.8 • n=20 Participants
|
37.4 years
STANDARD_DEVIATION 11.6 • n=20 Participants
|
40.5 years
STANDARD_DEVIATION 11.9 • n=40 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
33 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
25 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Ethnicity - Hispanic or Latino
|
4 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Ethnicity - Not Hispanic or Latino
|
34 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
50 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race - Black
|
18 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
29 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race - White
|
15 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Race - Multiple Race or Other
|
5 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Age at onset of regular smoking (years)
|
17.2 years
STANDARD_DEVIATION 5.1 • n=20 Participants
|
16.7 years
STANDARD_DEVIATION 3.2 • n=20 Participants
|
17.1 years
STANDARD_DEVIATION 4.5 • n=40 Participants
|
|
Cigarettes per day at admission
|
13.9 number of cigarettes per day
STANDARD_DEVIATION 8.1 • n=20 Participants
|
12.6 number of cigarettes per day
STANDARD_DEVIATION 8.5 • n=20 Participants
|
13.4 number of cigarettes per day
STANDARD_DEVIATION 8.2 • n=40 Participants
|
|
Heaviness of Smoking Index (HSI)
|
2.6 HSI total score
STANDARD_DEVIATION 1.5 • n=20 Participants
|
2.5 HSI total score
STANDARD_DEVIATION 1.5 • n=20 Participants
|
2.6 HSI total score
STANDARD_DEVIATION 1.5 • n=40 Participants
|
|
Tobacco Craving Questionnaire (TCQ)
|
40.1 TCQ total score
STANDARD_DEVIATION 16.8 • n=20 Participants
|
47.6 TCQ total score
STANDARD_DEVIATION 22.2 • n=20 Participants
|
42.7 TCQ total score
STANDARD_DEVIATION 19.0 • n=40 Participants
|
|
Smoking Abstinence Self-Efficacy (ASEQ)
|
25.1 ASEQ total score
STANDARD_DEVIATION 9.3 • n=20 Participants
|
29.6 ASEQ total score
STANDARD_DEVIATION 10.7 • n=20 Participants
|
26.7 ASEQ total score
STANDARD_DEVIATION 9.9 • n=40 Participants
|
|
Abstinence-Related Motivational Engagement (ARME)
|
83.5 ARME total score
STANDARD_DEVIATION 16.5 • n=20 Participants
|
83.3 ARME total score
STANDARD_DEVIATION 17.0 • n=20 Participants
|
83.4 ARME total score
STANDARD_DEVIATION 16.5 • n=40 Participants
|
PRIMARY outcome
Timeframe: 1 monthSelf-report 7-day point prevalence abstinence
Outcome measures
| Measure |
BecomeAnEX
n=17 Participants
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.
BecomeAnEX: 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: 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.
|
Usual Care
n=7 Participants
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.
Usual Care: 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
|
6 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 monthCraving was assessed with 11 items from the Tobacco Cravings Questionnaire (TCQ). Possible scores range from 11-77, with higher scores indicating greater tobacco craving.
Outcome measures
| Measure |
BecomeAnEX
n=17 Participants
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.
BecomeAnEX: 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: 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.
|
Usual Care
n=7 Participants
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.
Usual Care: 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.
|
|---|---|---|
|
Craving
|
35.3 Scores on a scale
Standard Deviation 21.4
|
47.7 Scores on a scale
Standard Deviation 16.0
|
PRIMARY outcome
Timeframe: 1 monthThe 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.
Outcome measures
| Measure |
BecomeAnEX
n=17 Participants
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.
BecomeAnEX: 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: 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.
|
Usual Care
n=7 Participants
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.
Usual Care: 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.
|
|---|---|---|
|
Self-efficacy
|
28.8 Scores on a scale
Standard Deviation 11.3
|
28.9 Scores on a scale
Standard Deviation 9.2
|
PRIMARY outcome
Timeframe: 1 monthThe 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.
Outcome measures
| Measure |
BecomeAnEX
n=17 Participants
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.
BecomeAnEX: 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: 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.
|
Usual Care
n=7 Participants
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.
Usual Care: 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.
|
|---|---|---|
|
Abstinence-Related Motivational
|
87.9 Scores on a scale
Standard Deviation 15.2
|
74.1 Scores on a scale
Standard Deviation 17.7
|
Adverse Events
BecomeAnEX
Usual Care
Serious adverse events
| Measure |
BecomeAnEX
n=38 participants at risk
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.
BecomeAnEX: 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: 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.
|
Usual Care
n=20 participants at risk
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.
Usual Care: 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.
|
|---|---|---|
|
Psychiatric disorders
Medical or psychiatric hospitalization of any duration
|
18.4%
7/38 • Number of events 7 • 3 months per participant, 18 months for the study
Serious adverse events: medical or psychiatric hospitalization of any duration. Other adverse events: emergency room visits for a medical or psychiatric reason that did not result in hospitalization.
|
20.0%
4/20 • Number of events 4 • 3 months per participant, 18 months for the study
Serious adverse events: medical or psychiatric hospitalization of any duration. Other adverse events: emergency room visits for a medical or psychiatric reason that did not result in hospitalization.
|
Other adverse events
| Measure |
BecomeAnEX
n=38 participants at risk
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.
BecomeAnEX: 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: 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.
|
Usual Care
n=20 participants at risk
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.
Usual Care: 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.
|
|---|---|---|
|
Psychiatric disorders
Emergency room visits for a medical or psychiatric reason that did not result in hospitalization.
|
10.5%
4/38 • Number of events 4 • 3 months per participant, 18 months for the study
Serious adverse events: medical or psychiatric hospitalization of any duration. Other adverse events: emergency room visits for a medical or psychiatric reason that did not result in hospitalization.
|
15.0%
3/20 • Number of events 3 • 3 months per participant, 18 months for the study
Serious adverse events: medical or psychiatric hospitalization of any duration. Other adverse events: emergency room visits for a medical or psychiatric reason that did not result in hospitalization.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place