Trial Outcomes & Findings for A Proof-of-concept RCT of Version 3.0 of the Smoking Cessation Smartphone App "Smiling Instead of Smoking" (SiS) (NCT NCT04672239)

NCT ID: NCT04672239

Last Updated: 2024-09-19

Results Overview

The Smoking Self-Efficacy Questionnaire (SEQ-12) (Etter, Bergman, Humair, \& Perneger, 2000) is a two-dimensional 12-item self-report scale measuring a person's confidence in his or her ability to abstain from smoking when facing internal stimuli (e.g. feeling depressed) and external stimuli (e.g. being with smokers) on a 0-100 slider scale (i.e., 0=not at all confident that I can refrain; 100=extremely confident that I can refrain). Scale scores are created by mean scoring across items and range from 0 to 100. Higher scores indicate greater self-efficacy to abstain from smoking.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

229 participants

Primary outcome timeframe

Up to 24 weeks post quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (baseline = week -1).

Results posted on

2024-09-19

Participant Flow

One participant in each treatment arm decided against the study during the onboarding process and before starting any study procedures. These were excluded from analysis in a modified intent to treat approach for an enrolled and active sample of n=226.

Participant milestones

Participant milestones
Measure
SiS App Treatment
Participants were onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS) Version 3, and were asked to use it for 7 weeks while they quit smoking.
QG App Treatment
Participants were onboarded (remotely) to the National Cancer Institute's (NCI) smartphone app "QuitGuide" (QG), and were asked to use it for 7 weeks while they quit smoking.
CTA Pamphlet
Participants were onboarded (remotely) to the National Cancer Institute's (NCI) brochure "Clearing the Air" (CTA), and were asked to use it for 7 weeks while they quit smoking.
Week 2 Survey
STARTED
80
75
71
Week 2 Survey
COMPLETED
69
69
59
Week 2 Survey
NOT COMPLETED
11
6
12
Week 6 Survey
STARTED
80
74
71
Week 6 Survey
COMPLETED
62
65
61
Week 6 Survey
NOT COMPLETED
18
9
10
3-Month Follow-up Survey
STARTED
79
72
70
3-Month Follow-up Survey
COMPLETED
57
62
53
3-Month Follow-up Survey
NOT COMPLETED
22
10
17
6-Month Follow-up Survey
STARTED
79
71
69
6-Month Follow-up Survey
COMPLETED
57
59
58
6-Month Follow-up Survey
NOT COMPLETED
22
12
11

Reasons for withdrawal

Reasons for withdrawal
Measure
SiS App Treatment
Participants were onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS) Version 3, and were asked to use it for 7 weeks while they quit smoking.
QG App Treatment
Participants were onboarded (remotely) to the National Cancer Institute's (NCI) smartphone app "QuitGuide" (QG), and were asked to use it for 7 weeks while they quit smoking.
CTA Pamphlet
Participants were onboarded (remotely) to the National Cancer Institute's (NCI) brochure "Clearing the Air" (CTA), and were asked to use it for 7 weeks while they quit smoking.
Week 2 Survey
Failed survey check items
1
2
3
Week 2 Survey
Partially completed survey
7
1
4
Week 2 Survey
Withdrawal by Subject
0
1
0
Week 2 Survey
Lost to Follow-up
3
2
5
Week 6 Survey
Failed survey check items
2
2
2
Week 6 Survey
Partially completed survey
3
3
2
Week 6 Survey
Withdrawal by Subject
1
1
1
Week 6 Survey
Withdrawn by PI
0
1
0
Week 6 Survey
Lost to Follow-up
12
2
5
3-Month Follow-up Survey
Failed survey check items
2
3
2
3-Month Follow-up Survey
Partially completed survey
3
1
3
3-Month Follow-up Survey
Withdrawal by Subject
0
1
1
3-Month Follow-up Survey
Lost to Follow-up
17
5
11
6-Month Follow-up Survey
Failed survey check items
2
0
0
6-Month Follow-up Survey
Partially completed survey
7
0
2
6-Month Follow-up Survey
Lost to Follow-up
13
12
9

Baseline Characteristics

Some participants declined to answer this question.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
SiS App Treatment
n=80 Participants
Participants were onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS) Version 3, and were asked to use it for 7 weeks while they quit smoking.
QG App Treatment
n=75 Participants
Participants were onboarded (remotely) to the National Cancer Institute's (NCI) smartphone app "QuitGuide" (QG), and were asked to use it for 7 weeks while they quit smoking.
CTA Pamphlet
n=71 Participants
Participants were onboarded (remotely) to the National Cancer Institute's (NCI) brochure "Clearing the Air" (CTA), and were asked to use it for 7 weeks while they quit smoking.
Total
n=226 Participants
Total of all reporting groups
Age, Continuous
41.3 years
STANDARD_DEVIATION 11.1 • n=80 Participants
41.6 years
STANDARD_DEVIATION 13.1 • n=75 Participants
40.0 years
STANDARD_DEVIATION 12.5 • n=71 Participants
41.0 years
STANDARD_DEVIATION 12.2 • n=226 Participants
Sex/Gender, Customized
Male
28 Participants
n=80 Participants
37 Participants
n=75 Participants
30 Participants
n=71 Participants
95 Participants
n=226 Participants
Sex/Gender, Customized
Female
51 Participants
n=80 Participants
36 Participants
n=75 Participants
41 Participants
n=71 Participants
128 Participants
n=226 Participants
Sex/Gender, Customized
Other
1 Participants
n=80 Participants
2 Participants
n=75 Participants
0 Participants
n=71 Participants
3 Participants
n=226 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
15 Participants
n=80 Participants
16 Participants
n=75 Participants
6 Participants
n=71 Participants
37 Participants
n=226 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
62 Participants
n=80 Participants
57 Participants
n=75 Participants
64 Participants
n=71 Participants
183 Participants
n=226 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants
n=80 Participants
2 Participants
n=75 Participants
1 Participants
n=71 Participants
6 Participants
n=226 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=80 Participants
0 Participants
n=75 Participants
1 Participants
n=71 Participants
1 Participants
n=226 Participants
Race (NIH/OMB)
Asian
1 Participants
n=80 Participants
1 Participants
n=75 Participants
4 Participants
n=71 Participants
6 Participants
n=226 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=80 Participants
0 Participants
n=75 Participants
0 Participants
n=71 Participants
0 Participants
n=226 Participants
Race (NIH/OMB)
Black or African American
23 Participants
n=80 Participants
19 Participants
n=75 Participants
13 Participants
n=71 Participants
55 Participants
n=226 Participants
Race (NIH/OMB)
White
50 Participants
n=80 Participants
46 Participants
n=75 Participants
48 Participants
n=71 Participants
144 Participants
n=226 Participants
Race (NIH/OMB)
More than one race
4 Participants
n=80 Participants
6 Participants
n=75 Participants
4 Participants
n=71 Participants
14 Participants
n=226 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=80 Participants
3 Participants
n=75 Participants
1 Participants
n=71 Participants
6 Participants
n=226 Participants
Highest level of education completed
High School or less
7 Participants
n=80 Participants
12 Participants
n=75 Participants
15 Participants
n=71 Participants
34 Participants
n=226 Participants
Highest level of education completed
Some college
31 Participants
n=80 Participants
38 Participants
n=75 Participants
25 Participants
n=71 Participants
94 Participants
n=226 Participants
Highest level of education completed
College degree or higher
42 Participants
n=80 Participants
25 Participants
n=75 Participants
30 Participants
n=71 Participants
97 Participants
n=226 Participants
Highest level of education completed
Declined to answer
0 Participants
n=80 Participants
0 Participants
n=75 Participants
1 Participants
n=71 Participants
1 Participants
n=226 Participants
Employment
Full-time
29 Participants
n=80 Participants
30 Participants
n=75 Participants
27 Participants
n=71 Participants
86 Participants
n=226 Participants
Employment
Part-time
14 Participants
n=80 Participants
11 Participants
n=75 Participants
18 Participants
n=71 Participants
43 Participants
n=226 Participants
Employment
Unemployed
32 Participants
n=80 Participants
33 Participants
n=75 Participants
23 Participants
n=71 Participants
88 Participants
n=226 Participants
Employment
Declined to answer
5 Participants
n=80 Participants
1 Participants
n=75 Participants
3 Participants
n=71 Participants
9 Participants
n=226 Participants
Household Income
$39,999 or less
41 Participants
n=80 Participants
42 Participants
n=75 Participants
30 Participants
n=71 Participants
113 Participants
n=226 Participants
Household Income
$40,000 - 69,999
18 Participants
n=80 Participants
18 Participants
n=75 Participants
22 Participants
n=71 Participants
58 Participants
n=226 Participants
Household Income
$70,000 - 99,999
16 Participants
n=80 Participants
8 Participants
n=75 Participants
10 Participants
n=71 Participants
34 Participants
n=226 Participants
Household Income
$100,000 or more
4 Participants
n=80 Participants
7 Participants
n=75 Participants
8 Participants
n=71 Participants
19 Participants
n=226 Participants
Household Income
Declined to answer
1 Participants
n=80 Participants
0 Participants
n=75 Participants
1 Participants
n=71 Participants
2 Participants
n=226 Participants
Rurality
Urban
39 Participants
n=80 Participants
34 Participants
n=75 Participants
27 Participants
n=71 Participants
100 Participants
n=226 Participants
Rurality
Suburban
29 Participants
n=80 Participants
24 Participants
n=75 Participants
35 Participants
n=71 Participants
88 Participants
n=226 Participants
Rurality
Rural
12 Participants
n=80 Participants
17 Participants
n=75 Participants
9 Participants
n=71 Participants
38 Participants
n=226 Participants
US region
Northeast
22 Participants
n=80 Participants
15 Participants
n=75 Participants
14 Participants
n=71 Participants
51 Participants
n=226 Participants
US region
Midwest
10 Participants
n=80 Participants
11 Participants
n=75 Participants
10 Participants
n=71 Participants
31 Participants
n=226 Participants
US region
South
34 Participants
n=80 Participants
34 Participants
n=75 Participants
29 Participants
n=71 Participants
97 Participants
n=226 Participants
US region
West
14 Participants
n=80 Participants
15 Participants
n=75 Participants
18 Participants
n=71 Participants
47 Participants
n=226 Participants
Number of days smoked in past 30 days
15.3 number of days
STANDARD_DEVIATION 5.4 • n=77 Participants • Some participants declined to answer this question.
14.7 number of days
STANDARD_DEVIATION 4.8 • n=75 Participants • Some participants declined to answer this question.
14.6 number of days
STANDARD_DEVIATION 4.5 • n=71 Participants • Some participants declined to answer this question.
14.9 number of days
STANDARD_DEVIATION 4.9 • n=223 Participants • Some participants declined to answer this question.
Cigarettes per smoking day
3.5 cigarettes per day
STANDARD_DEVIATION 2.9 • n=74 Participants • Some participants declined to answer this question.
3.0 cigarettes per day
STANDARD_DEVIATION 2.2 • n=69 Participants • Some participants declined to answer this question.
3.8 cigarettes per day
STANDARD_DEVIATION 3.0 • n=66 Participants • Some participants declined to answer this question.
3.4 cigarettes per day
STANDARD_DEVIATION 2.7 • n=209 Participants • Some participants declined to answer this question.
Fagerstrom Test for Nicotine Dependence, total score
1.0 units on a scale
n=79 Participants • One participant missed one or more items on the scale.
1.0 units on a scale
n=75 Participants • One participant missed one or more items on the scale.
1.0 units on a scale
n=71 Participants • One participant missed one or more items on the scale.
1.0 units on a scale
n=225 Participants • One participant missed one or more items on the scale.
Ever smoked daily?
Yes
54 Participants
n=80 Participants
53 Participants
n=75 Participants
44 Participants
n=71 Participants
151 Participants
n=226 Participants
Ever smoked daily?
No
25 Participants
n=80 Participants
22 Participants
n=75 Participants
27 Participants
n=71 Participants
74 Participants
n=226 Participants
Ever smoked daily?
Declined to answer
1 Participants
n=80 Participants
0 Participants
n=75 Participants
0 Participants
n=71 Participants
1 Participants
n=226 Participants
Ever tried to quit smoking before
Yes
49 Participants
n=80 Participants
56 Participants
n=75 Participants
52 Participants
n=71 Participants
157 Participants
n=226 Participants
Ever tried to quit smoking before
No
31 Participants
n=80 Participants
19 Participants
n=75 Participants
19 Participants
n=71 Participants
69 Participants
n=226 Participants
Ever used electronic cigarettes
Yes
46 Participants
n=80 Participants
41 Participants
n=75 Participants
46 Participants
n=71 Participants
133 Participants
n=226 Participants
Ever used electronic cigarettes
No
34 Participants
n=80 Participants
34 Participants
n=75 Participants
25 Participants
n=71 Participants
93 Participants
n=226 Participants
Currently uses electronic cigarettes
Yes
14 Participants
n=80 Participants
10 Participants
n=75 Participants
9 Participants
n=71 Participants
33 Participants
n=226 Participants
Currently uses electronic cigarettes
No
66 Participants
n=80 Participants
65 Participants
n=75 Participants
62 Participants
n=71 Participants
193 Participants
n=226 Participants
CES-D total scores
8.0 units on a scale
n=80 Participants
9.0 units on a scale
n=75 Participants
11.0 units on a scale
n=71 Participants
9.0 units on a scale
n=226 Participants
GAD-7 total scores
5.7 units on a scale
STANDARD_DEVIATION 4.8 • n=80 Participants
6.5 units on a scale
STANDARD_DEVIATION 5.4 • n=75 Participants
7.2 units on a scale
STANDARD_DEVIATION 5.1 • n=71 Participants
6.4 units on a scale
STANDARD_DEVIATION 5.1 • n=226 Participants
GSES total scores
31.9 units on a scale
STANDARD_DEVIATION 5.0 • n=80 Participants
31.7 units on a scale
STANDARD_DEVIATION 4.9 • n=75 Participants
30.8 units on a scale
STANDARD_DEVIATION 4.7 • n=71 Participants
31.5 units on a scale
STANDARD_DEVIATION 4.9 • n=226 Participants
Anhedonia
Yes
11 Participants
n=79 Participants • Two participants (1 from SiS App Treatment, 1 from CTA Pamphlet) missed two or more items on the scale, and scale scores were not calculated for them.
18 Participants
n=75 Participants • Two participants (1 from SiS App Treatment, 1 from CTA Pamphlet) missed two or more items on the scale, and scale scores were not calculated for them.
17 Participants
n=70 Participants • Two participants (1 from SiS App Treatment, 1 from CTA Pamphlet) missed two or more items on the scale, and scale scores were not calculated for them.
46 Participants
n=224 Participants • Two participants (1 from SiS App Treatment, 1 from CTA Pamphlet) missed two or more items on the scale, and scale scores were not calculated for them.
Anhedonia
No
68 Participants
n=79 Participants • Two participants (1 from SiS App Treatment, 1 from CTA Pamphlet) missed two or more items on the scale, and scale scores were not calculated for them.
57 Participants
n=75 Participants • Two participants (1 from SiS App Treatment, 1 from CTA Pamphlet) missed two or more items on the scale, and scale scores were not calculated for them.
53 Participants
n=70 Participants • Two participants (1 from SiS App Treatment, 1 from CTA Pamphlet) missed two or more items on the scale, and scale scores were not calculated for them.
178 Participants
n=224 Participants • Two participants (1 from SiS App Treatment, 1 from CTA Pamphlet) missed two or more items on the scale, and scale scores were not calculated for them.
Ever told they had a mental health or psychological condition
Yes
24 Participants
n=80 Participants
23 Participants
n=75 Participants
22 Participants
n=71 Participants
69 Participants
n=226 Participants
Ever told they had a mental health or psychological condition
No
56 Participants
n=80 Participants
52 Participants
n=75 Participants
49 Participants
n=71 Participants
157 Participants
n=226 Participants
SIMP - Extraversion
5.5 units on a scale
STANDARD_DEVIATION 2.1 • n=80 Participants
5.2 units on a scale
STANDARD_DEVIATION 2.5 • n=75 Participants
5.1 units on a scale
STANDARD_DEVIATION 2.5 • n=71 Participants
5.3 units on a scale
STANDARD_DEVIATION 2.4 • n=226 Participants
SIMP - Agreeableness
6.6 units on a scale
STANDARD_DEVIATION 1.9 • n=80 Participants
6.2 units on a scale
STANDARD_DEVIATION 2.4 • n=75 Participants
6.4 units on a scale
STANDARD_DEVIATION 2.1 • n=71 Participants
6.4 units on a scale
STANDARD_DEVIATION 2.1 • n=226 Participants
SIMP - Emotional stability
5.1 units on a scale
STANDARD_DEVIATION 2.4 • n=80 Participants
4.7 units on a scale
STANDARD_DEVIATION 2.2 • n=75 Participants
4.4 units on a scale
STANDARD_DEVIATION 1.9 • n=71 Participants
4.8 units on a scale
STANDARD_DEVIATION 2.2 • n=226 Participants
SIMP - Conscientiousness
5.2 units on a scale
STANDARD_DEVIATION 2.6 • n=80 Participants
5.2 units on a scale
STANDARD_DEVIATION 2.3 • n=75 Participants
5.7 units on a scale
STANDARD_DEVIATION 2.3 • n=71 Participants
5.4 units on a scale
STANDARD_DEVIATION 2.4 • n=226 Participants
SIMP - Openness
3.9 units on a scale
STANDARD_DEVIATION 2.1 • n=80 Participants
3.6 units on a scale
STANDARD_DEVIATION 2.0 • n=75 Participants
4.1 units on a scale
STANDARD_DEVIATION 2.3 • n=71 Participants
3.9 units on a scale
STANDARD_DEVIATION 2.1 • n=226 Participants
Any alcohol in the past 30 days
Yes
45 Participants
n=80 Participants
37 Participants
n=75 Participants
40 Participants
n=71 Participants
122 Participants
n=226 Participants
Any alcohol in the past 30 days
No
35 Participants
n=80 Participants
38 Participants
n=75 Participants
31 Participants
n=71 Participants
104 Participants
n=226 Participants
Any weeks of exceeding the drinking guidelines in the past 30 days
Yes
23 Participants
n=80 Participants
18 Participants
n=75 Participants
19 Participants
n=71 Participants
60 Participants
n=226 Participants
Any weeks of exceeding the drinking guidelines in the past 30 days
No
57 Participants
n=80 Participants
57 Participants
n=75 Participants
52 Participants
n=71 Participants
166 Participants
n=226 Participants
Any binge drinking in the past 30 days
Yes
25 Participants
n=80 Participants
15 Participants
n=75 Participants
18 Participants
n=71 Participants
58 Participants
n=226 Participants
Any binge drinking in the past 30 days
No
55 Participants
n=80 Participants
60 Participants
n=75 Participants
53 Participants
n=71 Participants
168 Participants
n=226 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks post quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (baseline = week -1).

Population: Some participants had missing data at various assessment time-points, but all enrolled participants provided data for at least one assessment.

The Smoking Self-Efficacy Questionnaire (SEQ-12) (Etter, Bergman, Humair, \& Perneger, 2000) is a two-dimensional 12-item self-report scale measuring a person's confidence in his or her ability to abstain from smoking when facing internal stimuli (e.g. feeling depressed) and external stimuli (e.g. being with smokers) on a 0-100 slider scale (i.e., 0=not at all confident that I can refrain; 100=extremely confident that I can refrain). Scale scores are created by mean scoring across items and range from 0 to 100. Higher scores indicate greater self-efficacy to abstain from smoking.

Outcome measures

Outcome measures
Measure
Smiling Instead of Smoking
n=80 Participants
Participants will be onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "Smiling instead of Smoking" (SiS) Version 3: Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking.
Quit Guide
n=75 Participants
Participants will be onboarded (remotely) to the smartphone app "QuitGuide" (QG), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "QuitGuide" (QG): Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking.
Clearing the Air
n=71 Participants
Participants will be onboarded (remotely) to the NCI brochure "Clearing the Air" (CTA), and will be asked to use it for 7 weeks while they quit smoking. Brochure "Clearing the Air" (CTA): Participants will be onboarded to the brochure "Clearing the Air" and will be asked to use it for 7 weeks to support them in quitting smoking.
End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)
Baseline
63.81 units on a scale
Standard Deviation 17.24
60.74 units on a scale
Standard Deviation 16.67
58.45 units on a scale
Standard Deviation 19.10
End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)
Week 2 post-quit
71.79 units on a scale
Standard Deviation 18.56
67.58 units on a scale
Standard Deviation 15.69
65.40 units on a scale
Standard Deviation 16.59
End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)
Week 6 post-quit
78.34 units on a scale
Standard Deviation 17.31
71.34 units on a scale
Standard Deviation 17.67
68.99 units on a scale
Standard Deviation 19.80
End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)
Week 12 post-quit (3-month follow-up)
81.16 units on a scale
Standard Deviation 17.35
76.20 units on a scale
Standard Deviation 19.50
75.22 units on a scale
Standard Deviation 19.12
End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)
Week 24 post-quit (6-month follow-up)
80.23 units on a scale
Standard Deviation 18.41
80.51 units on a scale
Standard Deviation 20.33
74.48 units on a scale
Standard Deviation 23.42

SECONDARY outcome

Timeframe: Assessed at 2, 6, 12, and 24 weeks post-quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants with missing data were assumed to be smoking (i.e., not 30-day point-prevalent abstinent from smoking).

Participants responded to the multiple choice question, "What is your current smoking status?" with answer options: "I smoke daily", "I smoke non-daily (and have smoked in the past 7 days)", "I smoke nondaily (but have NOT smoked in the past 7 days)", and "I do not smoke at all"). If participants reported that they did not smoke at all, they were asked: "Have you been abstinent during the past 30 days?" (yes/no). All participants who reported smoking daily or nondaily to the first question, or who reported not smoking at all but had smoking in the past 30 days, or those who left either of those questions unanswered were marked as NOT 30-day point prevalent smoking abstinent (not included in the abstinent count below). People who reported not smoking at all and being smoking-abstinent for the past 30 days were marked as 30-day point prevalent smoking abstinent (include in the abstinent count below).

Outcome measures

Outcome measures
Measure
Smiling Instead of Smoking
n=80 Participants
Participants will be onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "Smiling instead of Smoking" (SiS) Version 3: Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking.
Quit Guide
n=75 Participants
Participants will be onboarded (remotely) to the smartphone app "QuitGuide" (QG), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "QuitGuide" (QG): Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking.
Clearing the Air
n=71 Participants
Participants will be onboarded (remotely) to the NCI brochure "Clearing the Air" (CTA), and will be asked to use it for 7 weeks while they quit smoking. Brochure "Clearing the Air" (CTA): Participants will be onboarded to the brochure "Clearing the Air" and will be asked to use it for 7 weeks to support them in quitting smoking.
Self-reported 30-day Point-prevalence Abstinence
Week 2 post-quit
9 Participants
3 Participants
9 Participants
Self-reported 30-day Point-prevalence Abstinence
Week 6 post-quit
32 Participants
23 Participants
18 Participants
Self-reported 30-day Point-prevalence Abstinence
Week 12 post-quit (3-month follow-up)
36 Participants
31 Participants
21 Participants
Self-reported 30-day Point-prevalence Abstinence
Week 24 post-quit (6-month follow-up)
38 Participants
32 Participants
31 Participants

SECONDARY outcome

Timeframe: Assessed at 2, 6, 12, and 24 weeks post-quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: All available survey data at each assessment was used; by week 2 post-quit several participants had missing data for that and all subsequent assessments (n=3 for the SiS app, n=2 for the QG app, and n=3 for the CTA pamphlet groups).

If participants report having smoked in the past 7 days, they were asked to indicate how many cigarettes they smoked each day ("Last Monday:, Last Sunday:). Changes in cigarette consumption were calculated by subtracting the number of cigarettes smoked in the week leading up to the baseline assessment, as measured in the baseline survey, from the number of cigarettes smoked in the week leading up to the 2, 6, 12, and 24 week post-quit assessments, as assessed in these respective surveys.

Outcome measures

Outcome measures
Measure
Smiling Instead of Smoking
n=77 Participants
Participants will be onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "Smiling instead of Smoking" (SiS) Version 3: Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking.
Quit Guide
n=73 Participants
Participants will be onboarded (remotely) to the smartphone app "QuitGuide" (QG), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "QuitGuide" (QG): Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking.
Clearing the Air
n=68 Participants
Participants will be onboarded (remotely) to the NCI brochure "Clearing the Air" (CTA), and will be asked to use it for 7 weeks while they quit smoking. Brochure "Clearing the Air" (CTA): Participants will be onboarded to the brochure "Clearing the Air" and will be asked to use it for 7 weeks to support them in quitting smoking.
Self-reported Past Week Cigarette Change
Week 2 post-quit
-6.0 Change in weekly cigs since baseline
Interval -12.0 to -2.5
-6.0 Change in weekly cigs since baseline
Interval -11.0 to -3.0
-7.0 Change in weekly cigs since baseline
Interval -11.0 to -3.0
Self-reported Past Week Cigarette Change
Week 6 post-quit
-5.0 Change in weekly cigs since baseline
Interval -12.0 to -1.0
-6.0 Change in weekly cigs since baseline
Interval -11.0 to -3.0
-7.0 Change in weekly cigs since baseline
Interval -13.0 to -4.0
Self-reported Past Week Cigarette Change
Week 12 post-quit (3-month follow-up)
-6.0 Change in weekly cigs since baseline
Interval -12.0 to -1.5
-6.0 Change in weekly cigs since baseline
Interval -11.0 to -2.0
-7.0 Change in weekly cigs since baseline
Interval -13.5 to -3.0
Self-reported Past Week Cigarette Change
Week 24 post-quit (6-month follow-up)
-6.0 Change in weekly cigs since baseline
Interval -9.5 to 0.0
-6.0 Change in weekly cigs since baseline
Interval -10.0 to -2.0
-7.0 Change in weekly cigs since baseline
Interval -12.5 to -2.0

SECONDARY outcome

Timeframe: Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants with missing data were excluded from analysis.

As measured using the Client Satisfaction Scale (CSQ-8) (Larsen, 1979), an 8 item multiple choice measure that will be used to assess participants' satisfaction with the smoking cessation support they receive (e.g., "How satisfied are you with the amount of help you received?"). Scores are summed across items and range from 8 to 32, with higher scores indicating greater satisfaction.

Outcome measures

Outcome measures
Measure
Smiling Instead of Smoking
n=65 Participants
Participants will be onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "Smiling instead of Smoking" (SiS) Version 3: Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking.
Quit Guide
n=67 Participants
Participants will be onboarded (remotely) to the smartphone app "QuitGuide" (QG), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "QuitGuide" (QG): Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking.
Clearing the Air
n=63 Participants
Participants will be onboarded (remotely) to the NCI brochure "Clearing the Air" (CTA), and will be asked to use it for 7 weeks while they quit smoking. Brochure "Clearing the Air" (CTA): Participants will be onboarded to the brochure "Clearing the Air" and will be asked to use it for 7 weeks to support them in quitting smoking.
Satisfaction With Smoking Cessation Support
26.91 units on a scale
Standard Deviation 5.30
26.61 units on a scale
Standard Deviation 4.51
25.65 units on a scale
Standard Deviation 5.80

SECONDARY outcome

Timeframe: Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants with missing data were excluded from analysis.

Measured using the following single item, "During this past week, how much time did you spend applying or contemplating the content of the SiS app/QG app/"Clearing the Air"?" \[in minutes\].

Outcome measures

Outcome measures
Measure
Smiling Instead of Smoking
n=64 Participants
Participants will be onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "Smiling instead of Smoking" (SiS) Version 3: Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking.
Quit Guide
n=66 Participants
Participants will be onboarded (remotely) to the smartphone app "QuitGuide" (QG), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "QuitGuide" (QG): Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking.
Clearing the Air
n=63 Participants
Participants will be onboarded (remotely) to the NCI brochure "Clearing the Air" (CTA), and will be asked to use it for 7 weeks while they quit smoking. Brochure "Clearing the Air" (CTA): Participants will be onboarded to the brochure "Clearing the Air" and will be asked to use it for 7 weeks to support them in quitting smoking.
Time Spent Applying Content Brought up by the Apps/"Clearing the Air"
30.0 minutes per week
Interval 29.0 to 70.0
25.0 minutes per week
Interval 10.0 to 60.0
30.0 minutes per week
Interval 10.0 to 60.0

SECONDARY outcome

Timeframe: Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants with missing data were excluded from analysis.

Assessed using a study-specific, unpublished 8-item measure in which participants rated the extent to which they agreed or disagreed with statements about the smoking cessation support they received and the things they did while quitting (5-point Likert scale, 1=strongly disagree, 5=strongly agree, e.g., "I used \[the assigned treatment\] the way I was supposed to (in the days leading up to and following my quit attempt)." and "I avoided situations that would make me want to smoke."). The scores of the 8 items were averaged, so that scores could range from 1 to 5, where higher scores indicate stronger agreement with the use of a larger combination of smoking cessation strategies (i.e., a more positive outcome).

Outcome measures

Outcome measures
Measure
Smiling Instead of Smoking
n=63 Participants
Participants will be onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "Smiling instead of Smoking" (SiS) Version 3: Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking.
Quit Guide
n=65 Participants
Participants will be onboarded (remotely) to the smartphone app "QuitGuide" (QG), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "QuitGuide" (QG): Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking.
Clearing the Air
n=61 Participants
Participants will be onboarded (remotely) to the NCI brochure "Clearing the Air" (CTA), and will be asked to use it for 7 weeks while they quit smoking. Brochure "Clearing the Air" (CTA): Participants will be onboarded to the brochure "Clearing the Air" and will be asked to use it for 7 weeks to support them in quitting smoking.
Use of Smoking Cessation Strategies
4.13 units on a scale
Standard Deviation 0.63
3.90 units on a scale
Standard Deviation 0.59
3.97 units on a scale
Standard Deviation 0.69

SECONDARY outcome

Timeframe: Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants with missing data were excluded from analysis.

Assessed using a study-specific, unpublished 17-item measure in which participants rated the extent to which they agreed or disagreed with statements about the helpfulness of their assigned app during the quitting process (e.g., "\[the app\]...gave me confidence that I can quit smoking.", "\[the app\]... made me feel that I knew the right steps to take to quit.", and "\[the app\] ...reminded me in crucial moments to stay quit."). Items were rated on 5-point Likert scales ranging from 1="strongly disagree" to 5="strongly agree". The scores of the 17 items were averaged, so that scores could range from 1 to 5, where higher scores indicate stronger agreement with perceived impact of the smoking cessation support their assigned app provided (i.e., a more positive outcome).

Outcome measures

Outcome measures
Measure
Smiling Instead of Smoking
n=64 Participants
Participants will be onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "Smiling instead of Smoking" (SiS) Version 3: Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking.
Quit Guide
n=66 Participants
Participants will be onboarded (remotely) to the smartphone app "QuitGuide" (QG), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "QuitGuide" (QG): Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking.
Clearing the Air
n=63 Participants
Participants will be onboarded (remotely) to the NCI brochure "Clearing the Air" (CTA), and will be asked to use it for 7 weeks while they quit smoking. Brochure "Clearing the Air" (CTA): Participants will be onboarded to the brochure "Clearing the Air" and will be asked to use it for 7 weeks to support them in quitting smoking.
Perceived Impact of the Provided Materials on Quitting
4.13 units on a scale
Standard Deviation 0.72
3.98 units on a scale
Standard Deviation 0.55
3.84 units on a scale
Standard Deviation 0.73

SECONDARY outcome

Timeframe: Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants with missing data were excluded from analysis.

As measured using the Appreciation Scale, (Adler \& Fagley, 2005) an 18-item scale assessing the degree to which one is appreciative. Ten of the items assess frequency of action (e.g., "I do things to remind myself to be thankful", using a 7-point Likert scale of: 1 = "More than once a day" to 7 = "Never"). The remaining eight items assess level of agreement with appreciative statements (e.g., "I feel that it is a miracle to be alive", using a 7-point Likert scale of: 1 = "Strongly agree" to 7 = "Strongly disagree"). Item scores were summed to a total score with a possible range from 18 to 126 where higher scores indicate greater appreciation.

Outcome measures

Outcome measures
Measure
Smiling Instead of Smoking
n=64 Participants
Participants will be onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "Smiling instead of Smoking" (SiS) Version 3: Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking.
Quit Guide
n=66 Participants
Participants will be onboarded (remotely) to the smartphone app "QuitGuide" (QG), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "QuitGuide" (QG): Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking.
Clearing the Air
n=63 Participants
Participants will be onboarded (remotely) to the NCI brochure "Clearing the Air" (CTA), and will be asked to use it for 7 weeks while they quit smoking. Brochure "Clearing the Air" (CTA): Participants will be onboarded to the brochure "Clearing the Air" and will be asked to use it for 7 weeks to support them in quitting smoking.
Appreciation
108.91 units on a scale
Standard Deviation 13.46
106.28 units on a scale
Standard Deviation 15.29
104.98 units on a scale
Standard Deviation 14.26

SECONDARY outcome

Timeframe: Cumulative from week 0 to week 24 post-quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: All participants randomized to either of the app treatment groups (SiS or QG).

Number of days participants used the assigned app during the prescribed period of app use (i.e., 7 weeks for both apps). App usage is passively recorded by the app, which time-stamps every interaction with the app.

Outcome measures

Outcome measures
Measure
Smiling Instead of Smoking
n=80 Participants
Participants will be onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "Smiling instead of Smoking" (SiS) Version 3: Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking.
Quit Guide
n=75 Participants
Participants will be onboarded (remotely) to the smartphone app "QuitGuide" (QG), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "QuitGuide" (QG): Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking.
Clearing the Air
Participants will be onboarded (remotely) to the NCI brochure "Clearing the Air" (CTA), and will be asked to use it for 7 weeks while they quit smoking. Brochure "Clearing the Air" (CTA): Participants will be onboarded to the brochure "Clearing the Air" and will be asked to use it for 7 weeks to support them in quitting smoking.
Actual App Usage (SiS and QG Only)
32.5 number of days of app use
Interval 11.0 to 39.5
26.0 number of days of app use
Interval 11.0 to 38.0

SECONDARY outcome

Timeframe: From week 3 to week 6 post-quit. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants with missing data were excluded.

This was assessed via self-reported estimates of app use. Participants were asked on how many days they used the app in weeks 4, 5, and 6 post-quit ("On how many days per week did you use the app?"), and for how many minutes per typical day they used the assigned app ("On the days you used the app, how many minutes per day did you interact with the app?"). The days per week were multiplied by the minutes per app-use-day for each week, then averaged across the three weeks.

Outcome measures

Outcome measures
Measure
Smiling Instead of Smoking
n=59 Participants
Participants will be onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "Smiling instead of Smoking" (SiS) Version 3: Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking.
Quit Guide
n=63 Participants
Participants will be onboarded (remotely) to the smartphone app "QuitGuide" (QG), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "QuitGuide" (QG): Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking.
Clearing the Air
Participants will be onboarded (remotely) to the NCI brochure "Clearing the Air" (CTA), and will be asked to use it for 7 weeks while they quit smoking. Brochure "Clearing the Air" (CTA): Participants will be onboarded to the brochure "Clearing the Air" and will be asked to use it for 7 weeks to support them in quitting smoking.
Self-reported App Usage, Weeks 3 to 6 Post-quit (SiS and QG Only)
35.0 average minutes per week
Interval 21.0 to 70.0
22.5 average minutes per week
Interval 14.0 to 60.0

SECONDARY outcome

Timeframe: Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants with missing data were excluded from analysis.

Measured using the single item, "How much did you like using the smoking cessation app we asked you to use?" Participants respond on a 5-point Likert scale (1 = I strongly disliked using the app, 2 = I somewhat disliked using the app, 3 = I neither liked nor disliked using the app; 4 = I somewhat liked using the app, and 5 = I strongly liked using the app).

Outcome measures

Outcome measures
Measure
Smiling Instead of Smoking
n=64 Participants
Participants will be onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "Smiling instead of Smoking" (SiS) Version 3: Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking.
Quit Guide
n=65 Participants
Participants will be onboarded (remotely) to the smartphone app "QuitGuide" (QG), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "QuitGuide" (QG): Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking.
Clearing the Air
Participants will be onboarded (remotely) to the NCI brochure "Clearing the Air" (CTA), and will be asked to use it for 7 weeks while they quit smoking. Brochure "Clearing the Air" (CTA): Participants will be onboarded to the brochure "Clearing the Air" and will be asked to use it for 7 weeks to support them in quitting smoking.
Likability Rating of the App (SiS and QG Only)
4.19 units on a scale
Standard Deviation 0.99
4.08 units on a scale
Standard Deviation 0.87

SECONDARY outcome

Timeframe: Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants with missing data were excluded from analysis.

Measured using the single item, "How satisfied are you with the smoking cessation support this app provided you with?" Participants respond on a 5-point Likert scale (1 = very unsatisfied, 2 = somewhat dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = somewhat satisfied, 5 = very satisfied).

Outcome measures

Outcome measures
Measure
Smiling Instead of Smoking
n=64 Participants
Participants will be onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "Smiling instead of Smoking" (SiS) Version 3: Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking.
Quit Guide
n=64 Participants
Participants will be onboarded (remotely) to the smartphone app "QuitGuide" (QG), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "QuitGuide" (QG): Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking.
Clearing the Air
Participants will be onboarded (remotely) to the NCI brochure "Clearing the Air" (CTA), and will be asked to use it for 7 weeks while they quit smoking. Brochure "Clearing the Air" (CTA): Participants will be onboarded to the brochure "Clearing the Air" and will be asked to use it for 7 weeks to support them in quitting smoking.
Satisfaction Rating of the Smoking Cessation Support (SiS and QG Only)
4.25 units on a scale
Standard Deviation 1.04
4.11 units on a scale
Standard Deviation 0.94

SECONDARY outcome

Timeframe: Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).

Population: Participants who were randomized to the two app treatment conditions (SiS and QuitGuide) and who completed the week 6 survey only.

As assessed via the System Usability Scale (SUS; Brooke, 1996), a ten-item attitude scale giving a global view of subjective assessments of usability, adapted to include language specific to the smoking app (e.g., "I found the smoking app unnecessarily complex" 5-point Likert: 1 = strongly disagree, 5 = strongly agree). Scale scores range from 0 to 100 with greater scores indicating a more favorable perception of usability of the app.

Outcome measures

Outcome measures
Measure
Smiling Instead of Smoking
n=63 Participants
Participants will be onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "Smiling instead of Smoking" (SiS) Version 3: Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking.
Quit Guide
n=65 Participants
Participants will be onboarded (remotely) to the smartphone app "QuitGuide" (QG), and will be asked to use it for 7 weeks while they quit smoking. Smartphone app "QuitGuide" (QG): Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking.
Clearing the Air
Participants will be onboarded (remotely) to the NCI brochure "Clearing the Air" (CTA), and will be asked to use it for 7 weeks while they quit smoking. Brochure "Clearing the Air" (CTA): Participants will be onboarded to the brochure "Clearing the Air" and will be asked to use it for 7 weeks to support them in quitting smoking.
App Usability Ratings (SiS and QG Only)
81.91 units on a scale
Standard Deviation 17.10
79.48 units on a scale
Standard Deviation 15.99

Adverse Events

Smiling Instead of Smoking (SiS) App

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

QuitGuide (QG) App

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

Clearing the Air (CTA) Brochure

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

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bettina B. Hoeppner, Ph.D., MS

Recovery Research Institute, Department of Psychiatry, Massachusetts General Hospital

Phone: 617-643-1988

Results disclosure agreements

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