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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

59 participants

Primary outcome timeframe

1 month

Results posted on

2026-07-15

Participant Flow

The trial took place at two inpatient psychiatry units within a Mid-Atlantic hospital system.

Participant milestones

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

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

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 month

Self-report 7-day point prevalence abstinence

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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

Serious events: 7 serious events
Other events: 4 other events
Deaths: 0 deaths

Usual Care

Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

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

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

Dr. Melanie Bennett

Unive

Phone: 4107062490

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place