Nicotine Addiction, Serious Mental Illness
Conditions
Keywords
Smoking, mHealth, Serious Mental Illness, Acceptance and Commitment Therapy, US DHHS Clinical Practice Guidelines
Brief summary
Quitting smoking has important health benefits for people with serious mental illness, more than half of whom are smokers. Smoking reductions in this population, in turn, could contribute to saving billions of dollars in healthcare expenditures. Finding ways to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a pressing priority. Smartphone apps are a wide reaching technology that could provide a viable platform to deliver smoking cessation interventions for individuals with serious mental illness. However, do smoking cessation apps need to be tailored for people with serious mental illness to ensure their success? Or can providers simply use standard and freely available smoking cessation mobile health treatments designed for the general population? Furthermore, is it feasible to conduct mHealth trials in this population? Therefore, this trial will test whether (1) a tailored smoking cessation app for people with serious mental illness results in higher levels of engagement with smoking cessation content as compared to an app designed for the general population and (2) smoking cessation mHealth trials can be feasibly conducted in this population.
Detailed description
Smoking tobacco shortens the lifespan of adults with serious mental illness by 25 years and contributes to $317 billion expenditures in healthcare, indirect loss of earnings and disability benefits. Determining whether it is possible to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a high priority. Smartphone apps are a wide reaching technology that could provide individuals with serious mental illness the necessary skills for quitting. This feasibility trial will test whether a tailored smoking cessation app for people with serious mental illness, Learn to Quit, results in higher levels of engagement with smoking cessation content as compared to an app designed for the general population, NCI QuitGuide. The trial will also demonstrate whether it is possible to (a) feasibly recruit and retain individuals with serious mental illness in an mHealth clinical trial, and (b) successfully gather smoking cessation outcomes. Ninety individuals with serious mental illness will be randomly assigned to one of two conditions. In the experimental condition, participants will use the Learn to Quit app. In the comparator condition, participants will use the NCI QuitGuide app. Participants in both conditions will receive Nicotine Replacement Therapy (standard dosing of nicotine patch + 1-week course of 4mg nicotine lozenges) and technical coaching. Study duration will be 4 months, with four follow-up appointments at 1-month, 2-month, 3-month, and 4-months.
Interventions
DEVICELearn to Quit App
A smartphone app designed for individuals with serious mental illness. The main intervention components of the app are skills based on an intervention called Acceptance and Commitment Therapy that will (a) teach smoking cessation skills and (b) help cope with mental health symptoms. The app incorporates gaming features to keep users engaged, and a tracking component to record smoking habits and moods.
DRUGNicotine patch
Participants enrolled in the study will be given an 8-week course of Nicotine patches. The 8-week course of trans-dermal nicotine patches starting at 21mg/24h for 4 weeks, then transitioning to 14mg/24h for 2 weeks, and finally to 7mg/24h for the last 2 weeks. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines.
DRUGNicotine lozenge
Each participant will be given a 1-week course of 4mg Nicotine lozenges to be taken orally as nicotine cravings arise (about 10 lozenges per day). They will be directed to use them for the week following their quit date, using no more than once every 1-2 hours. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines.
BEHAVIORALTechnical Coaching
Coaching to assist the user on the use of each assigned smartphone app. This coaching will be delivered by research staff following a coaching procedure. These in-person coaching meetings will be brief (\ 15 minutes), done on a weekly basis for 4 weeks, and will have a focus on providing technical assistance.
DEVICENCI QuitGuide App
A smartphone app developed by the National Cancer Institute which uses recommendations contained in the US DHHS Clinical Practice Guidelines and smokefree.gov. NCI QuitGuide has the following intervention components: (a) psycho-education about the impact of smoking in health, (b) tracking of smoking habits, and (c) Tips for quitting (e.g., distraction strategies).
Sponsors
National Institute on Drug Abuse (NIDA)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will be assigned to one of two smoking cessation apps for the duration of the study: Learn to Quit or NCI QuitGuide. One app was designed to address the needs of people with serious mental illness (Learn to Quit) and the other was designed for the general population (NCI QuitGuide).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ICD-10 diagnosis of schizophrenia, schizoaffective, bipolar or recurring depressive disorder * Smoking ≥ 5 cigarettes per day over the past 30 days * Desire to quit smoking in the next 30 days * Willing and medically eligible to use Nicotine Replacement Therapy * Fluent in spoken and written English * Working email, mailing address, or alternative contact person * Taking psychiatric medications as prescribed by their provider * Stable housing
Exclusion criteria
* Problematic alcohol or illicit drug use in the last 30 days * Acute psychotic episode, unsafe to participate in the study, or psychiatrically unstable * Pregnant, breastfeeding, or having the intention to become pregnant in the next 4 months * Hearing, comprehension, or visual limitations that preclude study participation * Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation * Using non-cigarette forms of tobacco as the primary source of nicotine (e.g. e-cigarettes, chew)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days of App Use | Daily throughout study duration, 4 months | Frequency of app openings in each group |
| Duration of App Use | Daily throughout study duration, 4 months | Mean duration of app use in each group over the course of study participation (4 months) |
| Feasibility as Measured by Study Accrual Relative to Recruitment Goal | Approximately 15 months | Percent of subjects consented into study relative to study recruitment goal (N=90).92 subjects signed consent prior to eligibility determination and randomization. |
| Feasibility as Measured by Study Attrition | 4-months | Number and percentage of subjects who complete 4-month follow up assessment |
| Recruitment Yield Effort | Approximately 15 months | Percent of subjects responding to ads and clinician referrals |
| Feasibility of Measurement Strategy | Approximately 19 months | Percent completion of assessment measures. Assessment measures include surveys, questionnaires, and cognitive tasks. |
| Usability of App Design as Measured by the System Usability Scale (SUS) | 1-month follow-up | 10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence | Baseline to 1, 2, 3 and 4 month follow up | The Fagerstrom Test of Nicotine Dependence ranges from 0 to 10 with the lower score indicating no dependence and the highest score indicating very dependent |
| Change in Average Number of Cigarettes Smoked Per Day | Baseline to 1, 2, 3 and 4 month follow up | Change in average number of self-reported cigarettes smoked per day per arm from baseline to the specified time point. |
| Nicotine Replacement Patch Utilization | 1 month follow up | Days of patch use over the last 30 days. |
| Nicotine Replacement Lozenge Utilization | 1 month follow up | Days of lozenge use over the last 30 days. |
| Biochemically Confirmed 7-day Point Prevalence Abstinence | 1 month follow-up | Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent. |
| Affect Ratings - QuitGuide | Daily throughout study, 4 months | Percent of reported positive, negative, and mixed affect. Negative affect was coded as '1' when the following types of mood were reported using the mood tracking feature within the app: frustrated, stressed, nervous, anxious, angry, sad. Positive affect was coded as '1' when the following types of mood were reported using the mood tracking feature within the app: happy, relaxed, excited. Mixed affect was coded as '1' when there were instances where participants reported both positive and negative affect at different times of the day. |
| Smoking Cravings | Daily throughout study duration, 4 months | Average daily smoking cravings as self-reported through each smartphone app. Cravings range from a score of 1 to 10 with higher scores indicating higher cravings to smoke. |
| Psychotic Symptoms | 1 month follow up | Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology. |
| General Psychiatric Symptoms | 1 month follow up | General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms. |
| Affect Ratings - Learn to Quit | Daily throughout study duration, 4 months | Average mood rating as self-reported through the Learn to Quit app. Ratings range from 1-10 with lower scores indicating poorer mood ratings. |
| Biochemically Confirmed Prolonged Abstinence Rates | 1 month follow up | Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent |
| 30-day Point Prevalence Abstinence Rates | 1 month follow up | Participants who self-reported not smoking for 30 days prior to the specified timepoint. |
| 30-day Prevalence Abstinence Rates | 3 month follow up | Participants who self-reported not smoking for 30 days prior to the specified timepoint. |
| 7-day Point Prevalence Abstinence | 1 month follow up | Participants who self-reported not smoking for 7 days prior to the specified timepoint. |
| 24-hour Point Prevalence Abstinence | 1 month follow up | Participants who self-reported not smoking for 24 hours prior to the specified timepoint. |
| Average Number of Quit Attempts Per Arm | 1 month follow up | Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Learn to Quit A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study. | 33 |
| NCI QuitGuide A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines. The app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 2-week course of NRT lozenges. Participants also receive technical smartphone coaching for the first 4 weeks of the study. | 29 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | NCI QuitGuide | Total | Learn to Quit |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 60 Participants | 31 Participants |
| Age, Continuous | 45.6 years STANDARD_DEVIATION 10.9 | 47.1 years STANDARD_DEVIATION 11 | 48.4 years STANDARD_DEVIATION 11.2 |
| Bipolar Diagnosis | 15 Participants | 30 Participants | 15 Participants |
| Cognitive Functioning | -0.9 units on a scale | -0.95 units on a scale | -1 units on a scale |
| CPD at Baseline | 14 cigarettes per day STANDARD_DEVIATION 6.4 | 17.9 cigarettes per day STANDARD_DEVIATION 12.6 | 21 cigarettes per day STANDARD_DEVIATION 15.5 |
| Disability Status | 9 Participants | 28 Participants | 19 Participants |
| Education Levels Associate's Degree | 5 Participants | 9 Participants | 4 Participants |
| Education Levels Bachelor's Degree or Higher | 6 Participants | 15 Participants | 9 Participants |
| Education Levels Secondary School or Less | 10 Participants | 21 Participants | 11 Participants |
| Education Levels Some College | 8 Participants | 17 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 61 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Household Income >$100,000 | 4 Participants | 8 Participants | 4 Participants |
| Household Income <$35,000 | 18 Participants | 42 Participants | 24 Participants |
| Household Income $35-50,0000 | 2 Participants | 6 Participants | 4 Participants |
| Household Income $50-75,000 | 4 Participants | 4 Participants | 0 Participants |
| Household Income $75-100,000 | 1 Participants | 2 Participants | 1 Participants |
| MDD Diagnosis | 9 Participants | 17 Participants | 8 Participants |
| Nicotine Dependence | 4.7 units on a scale STANDARD_DEVIATION 2.3 | 5.0 units on a scale STANDARD_DEVIATION 2.5 | 5.2 units on a scale STANDARD_DEVIATION 2.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 25 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 32 Participants | 16 Participants |
| Region of Enrollment United States | 29 participants | 62 participants | 33 participants |
| Schizophrenia Spectrum Diagnosis | 5 Participants | 15 Participants | 10 Participants |
| Sex: Female, Male Female | 16 Participants | 37 Participants | 21 Participants |
| Sex: Female, Male Male | 13 Participants | 25 Participants | 12 Participants |
| Years of Smoking | 26.8 years STANDARD_DEVIATION 11.3 | 26.2 years STANDARD_DEVIATION 12.1 | 25.6 years STANDARD_DEVIATION 12.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 29 |
| other Total, other adverse events | 30 / 33 | 23 / 29 |
| serious Total, serious adverse events | 6 / 33 | 4 / 29 |
Outcome results
Primary
Days of App Use
Frequency of app openings in each group
Time frame: Daily throughout study duration, 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Days of App Use | 34.1 days | Standard Deviation 27.7 |
| NCI QuitGuide | Days of App Use | 32 days | Standard Deviation 24.5 |
p-value: =0.754ANOVA
Primary
Duration of App Use
Mean duration of app use in each group over the course of study participation (4 months)
Time frame: Daily throughout study duration, 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Duration of App Use | 4.24 hours | Standard Deviation 4.29 |
| NCI QuitGuide | Duration of App Use | 2.14 hours | Standard Deviation 1.72 |
p-value: 0.04495% CI: [1.2, 2.6]Mixed Models Analysis
Primary
Feasibility as Measured by Study Accrual Relative to Recruitment Goal
Percent of subjects consented into study relative to study recruitment goal (N=90).92 subjects signed consent prior to eligibility determination and randomization.
Time frame: Approximately 15 months
Population: The number of participants analyzed in this sample is larger than the number of participants who were ultimately randomized to the study as reflected in the participant flow section. This sample includes all participants who were consented into the study regardless of their final eligibility status prior to randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Learn to Quit | Feasibility as Measured by Study Accrual Relative to Recruitment Goal | 102 percentage of target accrual |
Primary
Feasibility as Measured by Study Attrition
Number and percentage of subjects who complete 4-month follow up assessment
Time frame: 4-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | Feasibility as Measured by Study Attrition | 33 Participants |
| NCI QuitGuide | Feasibility as Measured by Study Attrition | 28 Participants |
Primary
Feasibility of Measurement Strategy
Percent completion of assessment measures. Assessment measures include surveys, questionnaires, and cognitive tasks.
Time frame: Approximately 19 months
Population: Number of total possible assessment measures that could have been completed in each group.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Learn to Quit | Feasibility of Measurement Strategy | 1353 assessments |
| NCI QuitGuide | Feasibility of Measurement Strategy | 1284 assessments |
Primary
Recruitment Yield Effort
Percent of subjects responding to ads and clinician referrals
Time frame: Approximately 15 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | Recruitment Yield Effort | 290 Participants |
Primary
Usability of App Design as Measured by the System Usability Scale (SUS)
10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
Time frame: 1-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Usability of App Design as Measured by the System Usability Scale (SUS) | 87.3 score on a scale | Standard Deviation 13.6 |
| NCI QuitGuide | Usability of App Design as Measured by the System Usability Scale (SUS) | 79.4 score on a scale | Standard Deviation 15 |
p-value: 0.04695% CI: [0.138, 16.453]Yuen's trimmed mean t-test
Primary
Usability of App Design as Measured by the System Usability Scale (SUS)
10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
Time frame: 4-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Usability of App Design as Measured by the System Usability Scale (SUS) | 85.2 score on a scale | Standard Deviation 13.9 |
| NCI QuitGuide | Usability of App Design as Measured by the System Usability Scale (SUS) | 78.7 score on a scale | Standard Deviation 19.3 |
p-value: 0.2741195% CI: [-4.88, 16.54]Yuen's trimmed means t-test
Primary
Usability of App Design as Measured by the System Usability Scale (SUS)
10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
Time frame: 3-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Usability of App Design as Measured by the System Usability Scale (SUS) | 83.2 score on a scale | Standard Deviation 14.1 |
| NCI QuitGuide | Usability of App Design as Measured by the System Usability Scale (SUS) | 80.8 score on a scale | Standard Deviation 15.6 |
p-value: 0.5053795% CI: [-4.492, 8.943]Yuen's trimmed means t-test
Primary
Usability of App Design as Measured by the System Usability Scale (SUS)
10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.
Time frame: 2-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Usability of App Design as Measured by the System Usability Scale (SUS) | 84.4 score on a scale | Standard Deviation 13.5 |
| NCI QuitGuide | Usability of App Design as Measured by the System Usability Scale (SUS) | 75.6 score on a scale | Standard Deviation 19.6 |
p-value: 0.10995% CI: [-1.867, 17.457]Yuen's trimmed means t-test
Secondary
24-hour Point Prevalence Abstinence
Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
Time frame: 3 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | 24-hour Point Prevalence Abstinence | 6 Participants |
| NCI QuitGuide | 24-hour Point Prevalence Abstinence | 6 Participants |
Secondary
24-hour Point Prevalence Abstinence
Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
Time frame: 2 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | 24-hour Point Prevalence Abstinence | 8 Participants |
| NCI QuitGuide | 24-hour Point Prevalence Abstinence | 7 Participants |
Secondary
24-hour Point Prevalence Abstinence
Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
Time frame: 1 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | 24-hour Point Prevalence Abstinence | 8 Participants |
| NCI QuitGuide | 24-hour Point Prevalence Abstinence | 10 Participants |
Secondary
24-hour Point Prevalence Abstinence
Participants who self-reported not smoking for 24 hours prior to the specified timepoint.
Time frame: 4 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | 24-hour Point Prevalence Abstinence | 7 Participants |
| NCI QuitGuide | 24-hour Point Prevalence Abstinence | 7 Participants |
Secondary
30-day Point Prevalence Abstinence Rates
Participants who self-reported not smoking for 30 days prior to the specified timepoint.
Time frame: 4 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | 30-day Point Prevalence Abstinence Rates | 4 Participants |
| NCI QuitGuide | 30-day Point Prevalence Abstinence Rates | 3 Participants |
Secondary
30-day Point Prevalence Abstinence Rates
Participants who self-reported not smoking for 30 days prior to the specified timepoint.
Time frame: 1 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | 30-day Point Prevalence Abstinence Rates | 0 Participants |
| NCI QuitGuide | 30-day Point Prevalence Abstinence Rates | 1 Participants |
Secondary
30-day Point Prevalence Abstinence Rates
Participants who self-reported not smoking for 30 days prior to the specified timepoint.
Time frame: 2 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | 30-day Point Prevalence Abstinence Rates | 3 Participants |
| NCI QuitGuide | 30-day Point Prevalence Abstinence Rates | 2 Participants |
Secondary
30-day Prevalence Abstinence Rates
Participants who self-reported not smoking for 30 days prior to the specified timepoint.
Time frame: 3 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | 30-day Prevalence Abstinence Rates | 1 Participants |
| NCI QuitGuide | 30-day Prevalence Abstinence Rates | 3 Participants |
Secondary
7-day Point Prevalence Abstinence
Participants who self-reported not smoking for 7 days prior to the specified timepoint.
Time frame: 3 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | 7-day Point Prevalence Abstinence | 5 Participants |
| NCI QuitGuide | 7-day Point Prevalence Abstinence | 4 Participants |
Secondary
7-day Point Prevalence Abstinence
Participants who self-reported not smoking for 7 days prior to the specified timepoint.
Time frame: 4 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | 7-day Point Prevalence Abstinence | 4 Participants |
| NCI QuitGuide | 7-day Point Prevalence Abstinence | 3 Participants |
Secondary
7-day Point Prevalence Abstinence
Participants who self-reported not smoking for 7 days prior to the specified timepoint.
Time frame: 1 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | 7-day Point Prevalence Abstinence | 4 Participants |
| NCI QuitGuide | 7-day Point Prevalence Abstinence | 7 Participants |
Secondary
7-day Point Prevalence Abstinence
Participants who self-reported not smoking for 7 days prior to the specified timepoint.
Time frame: 2 month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | 7-day Point Prevalence Abstinence | 6 Participants |
| NCI QuitGuide | 7-day Point Prevalence Abstinence | 2 Participants |
Secondary
Affect Ratings - Learn to Quit
Average mood rating as self-reported through the Learn to Quit app. Ratings range from 1-10 with lower scores indicating poorer mood ratings.
Time frame: Daily throughout study duration, 4 months
Population: Participants in the Learn to Quit group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Affect Ratings - Learn to Quit | 5.4666165 score on a scale | Standard Deviation 2.155668 |
Secondary
Affect Ratings - QuitGuide
Percent of reported positive, negative, and mixed affect. Negative affect was coded as '1' when the following types of mood were reported using the mood tracking feature within the app: frustrated, stressed, nervous, anxious, angry, sad. Positive affect was coded as '1' when the following types of mood were reported using the mood tracking feature within the app: happy, relaxed, excited. Mixed affect was coded as '1' when there were instances where participants reported both positive and negative affect at different times of the day.
Time frame: Daily throughout study, 4 months
Population: Participants in the QuitGuide group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Learn to Quit | Affect Ratings - QuitGuide | Positive Affect | 52.26 Percent of counts |
| Learn to Quit | Affect Ratings - QuitGuide | Negative Affect | 43.90 Percent of counts |
| Learn to Quit | Affect Ratings - QuitGuide | Mixed Affect | 3.83 Percent of counts |
Secondary
Average Number of Quit Attempts Per Arm
Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
Time frame: 3 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Average Number of Quit Attempts Per Arm | 1.83 quit attempts | Standard Deviation 2.17 |
| NCI QuitGuide | Average Number of Quit Attempts Per Arm | 3.30 quit attempts | Standard Deviation 3.61 |
Secondary
Average Number of Quit Attempts Per Arm
Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
Time frame: 4 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Average Number of Quit Attempts Per Arm | 1.61 quit attempts | Standard Deviation 1.85 |
| NCI QuitGuide | Average Number of Quit Attempts Per Arm | 1.96 quit attempts | Standard Deviation 1.9 |
Secondary
Average Number of Quit Attempts Per Arm
Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
Time frame: 1 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Average Number of Quit Attempts Per Arm | 1.16 quit attempts | Standard Deviation 1.19 |
| NCI QuitGuide | Average Number of Quit Attempts Per Arm | 3.04 quit attempts | Standard Deviation 2.29 |
Secondary
Average Number of Quit Attempts Per Arm
Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.
Time frame: 2 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Average Number of Quit Attempts Per Arm | 1.44 quit attempts | Standard Deviation 1.34 |
| NCI QuitGuide | Average Number of Quit Attempts Per Arm | 2.55 quit attempts | Standard Deviation 1.82 |
Secondary
Biochemically Confirmed 7-day Point Prevalence Abstinence
Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Time frame: 3 month follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | Biochemically Confirmed 7-day Point Prevalence Abstinence | 3 Participants |
| NCI QuitGuide | Biochemically Confirmed 7-day Point Prevalence Abstinence | 2 Participants |
Secondary
Biochemically Confirmed 7-day Point Prevalence Abstinence
Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Time frame: 1 month follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | Biochemically Confirmed 7-day Point Prevalence Abstinence | 3 Participants |
| NCI QuitGuide | Biochemically Confirmed 7-day Point Prevalence Abstinence | 5 Participants |
Secondary
Biochemically Confirmed 7-day Point Prevalence Abstinence
Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Time frame: 4 month follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | Biochemically Confirmed 7-day Point Prevalence Abstinence | 4 Participants |
| NCI QuitGuide | Biochemically Confirmed 7-day Point Prevalence Abstinence | 1 Participants |
Secondary
Biochemically Confirmed 7-day Point Prevalence Abstinence
Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Time frame: 2 month follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | Biochemically Confirmed 7-day Point Prevalence Abstinence | 6 Participants |
| NCI QuitGuide | Biochemically Confirmed 7-day Point Prevalence Abstinence | 0 Participants |
Secondary
Biochemically Confirmed Prolonged Abstinence Rates
Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent
Time frame: 2 month follow up
Population: A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | Biochemically Confirmed Prolonged Abstinence Rates | 0 Participants |
| NCI QuitGuide | Biochemically Confirmed Prolonged Abstinence Rates | 0 Participants |
Secondary
Biochemically Confirmed Prolonged Abstinence Rates
Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent
Time frame: 1 month follow up
Population: A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | Biochemically Confirmed Prolonged Abstinence Rates | 4 Participants |
| NCI QuitGuide | Biochemically Confirmed Prolonged Abstinence Rates | 3 Participants |
Secondary
Biochemically Confirmed Prolonged Abstinence Rates
Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Time frame: 4 month follow up
Population: A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | Biochemically Confirmed Prolonged Abstinence Rates | 0 Participants |
| NCI QuitGuide | Biochemically Confirmed Prolonged Abstinence Rates | 0 Participants |
Secondary
Biochemically Confirmed Prolonged Abstinence Rates
Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Time frame: 3 month follow up
Population: A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Learn to Quit | Biochemically Confirmed Prolonged Abstinence Rates | 0 Participants |
| NCI QuitGuide | Biochemically Confirmed Prolonged Abstinence Rates | 0 Participants |
Secondary
Change in Average Number of Cigarettes Smoked Per Day
Change in average number of self-reported cigarettes smoked per day per arm from baseline to the specified time point.
Time frame: Baseline to 1, 2, 3 and 4 month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Learn to Quit | Change in Average Number of Cigarettes Smoked Per Day | Week 4 | 10.0 cigarettes per day | Standard Deviation 9.9 |
| Learn to Quit | Change in Average Number of Cigarettes Smoked Per Day | Week 8 | 11.3 cigarettes per day | Standard Deviation 12 |
| Learn to Quit | Change in Average Number of Cigarettes Smoked Per Day | Week 12 | 11.5 cigarettes per day | Standard Deviation 12.3 |
| Learn to Quit | Change in Average Number of Cigarettes Smoked Per Day | Week 16 | 12.3 cigarettes per day | Standard Deviation 11.5 |
| NCI QuitGuide | Change in Average Number of Cigarettes Smoked Per Day | Week 16 | 5.9 cigarettes per day | Standard Deviation 5.9 |
| NCI QuitGuide | Change in Average Number of Cigarettes Smoked Per Day | Week 4 | 5.2 cigarettes per day | Standard Deviation 10.8 |
| NCI QuitGuide | Change in Average Number of Cigarettes Smoked Per Day | Week 12 | 6.0 cigarettes per day | Standard Deviation 7.6 |
| NCI QuitGuide | Change in Average Number of Cigarettes Smoked Per Day | Week 8 | 7.5 cigarettes per day | Standard Deviation 7.6 |
Secondary
Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence
The Fagerstrom Test of Nicotine Dependence ranges from 0 to 10 with the lower score indicating no dependence and the highest score indicating very dependent
Time frame: Baseline to 1, 2, 3 and 4 month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Learn to Quit | Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence | Week 4 | 0.81 units on a scale | Standard Deviation 2.17 |
| Learn to Quit | Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence | Week 8 | 1 units on a scale | Standard Deviation 1.97 |
| Learn to Quit | Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence | Week 12 | 1.29 units on a scale | Standard Deviation 2.03 |
| Learn to Quit | Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence | Week 16 | 1.16 units on a scale | Standard Deviation 2.03 |
| NCI QuitGuide | Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence | Week 16 | 1.35 units on a scale | Standard Deviation 2.48 |
| NCI QuitGuide | Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence | Week 4 | 1.88 units on a scale | Standard Deviation 2.9 |
| NCI QuitGuide | Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence | Week 12 | 1.74 units on a scale | Standard Deviation 2.4 |
| NCI QuitGuide | Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence | Week 8 | 1.47 units on a scale | Standard Deviation 2.67 |
Secondary
General Psychiatric Symptoms
General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.
Time frame: 2 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | General Psychiatric Symptoms | 0.87 score on a scale | Standard Deviation 0.64 |
| NCI QuitGuide | General Psychiatric Symptoms | 0.68 score on a scale | Standard Deviation 0.58 |
Secondary
General Psychiatric Symptoms
General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.
Time frame: 4 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | General Psychiatric Symptoms | 0.94 score on a scale | Standard Deviation 0.75 |
| NCI QuitGuide | General Psychiatric Symptoms | 0.90 score on a scale | Standard Deviation 0.64 |
Secondary
General Psychiatric Symptoms
General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.
Time frame: 3 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | General Psychiatric Symptoms | 0.80 score on a scale | Standard Deviation 0.58 |
| NCI QuitGuide | General Psychiatric Symptoms | 0.80 score on a scale | Standard Deviation 0.6 |
Secondary
General Psychiatric Symptoms
General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.
Time frame: 1 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | General Psychiatric Symptoms | 0.92 score on a scale | Standard Deviation 0.59 |
| NCI QuitGuide | General Psychiatric Symptoms | 0.84 score on a scale | Standard Deviation 0.65 |
Secondary
Nicotine Replacement Lozenge Utilization
Days of lozenge use over the last 30 days.
Time frame: 2 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Nicotine Replacement Lozenge Utilization | 5.1 days of lozenge use | Standard Deviation 9.3 |
| NCI QuitGuide | Nicotine Replacement Lozenge Utilization | 7 days of lozenge use | Standard Deviation 10.4 |
Secondary
Nicotine Replacement Lozenge Utilization
Days of lozenge use over the last 30 days.
Time frame: 3 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Nicotine Replacement Lozenge Utilization | 4.4 days of lozenge use | Standard Deviation 8 |
| NCI QuitGuide | Nicotine Replacement Lozenge Utilization | 4.1 days of lozenge use | Standard Deviation 7.2 |
Secondary
Nicotine Replacement Lozenge Utilization
Days of lozenge use over the last 30 days.
Time frame: 4 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Nicotine Replacement Lozenge Utilization | 2.3 days of lozenge use | Standard Deviation 6.3 |
| NCI QuitGuide | Nicotine Replacement Lozenge Utilization | 1.3 days of lozenge use | Standard Deviation 3.1 |
Secondary
Nicotine Replacement Lozenge Utilization
Days of lozenge use over the last 30 days.
Time frame: 1 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Nicotine Replacement Lozenge Utilization | 7.8 days of lozenge use | Standard Deviation 9.7 |
| NCI QuitGuide | Nicotine Replacement Lozenge Utilization | 10 days of lozenge use | Standard Deviation 10 |
Secondary
Nicotine Replacement Patch Utilization
Days of patch use over the last 30 days.
Time frame: 2 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Nicotine Replacement Patch Utilization | 11 days of patch use | Standard Deviation 11.2 |
| NCI QuitGuide | Nicotine Replacement Patch Utilization | 14.9 days of patch use | Standard Deviation 12.8 |
Secondary
Nicotine Replacement Patch Utilization
Days of patch use over the last 30 days.
Time frame: 1 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Nicotine Replacement Patch Utilization | 10.3 days of patch use | Standard Deviation 10.4 |
| NCI QuitGuide | Nicotine Replacement Patch Utilization | 13.9 days of patch use | Standard Deviation 11.6 |
Secondary
Nicotine Replacement Patch Utilization
Days of patch use over the last 30 days.
Time frame: 3 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Nicotine Replacement Patch Utilization | 8.4 days of patch use | Standard Deviation 10.7 |
| NCI QuitGuide | Nicotine Replacement Patch Utilization | 7.4 days of patch use | Standard Deviation 9.5 |
Secondary
Nicotine Replacement Patch Utilization
Days of patch use over the last 30 days.
Time frame: 4 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Nicotine Replacement Patch Utilization | 3.4 days of patch use | Standard Deviation 6.2 |
| NCI QuitGuide | Nicotine Replacement Patch Utilization | 5.3 days of patch use | Standard Deviation 8.6 |
Secondary
Psychotic Symptoms
Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.
Time frame: 4 month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Learn to Quit | Psychotic Symptoms | Positive symptoms | 11.63 score on a scale | Standard Deviation 4.53 |
| Learn to Quit | Psychotic Symptoms | Negative symptoms | 12.16 score on a scale | Standard Deviation 4.25 |
| NCI QuitGuide | Psychotic Symptoms | Positive symptoms | 11.55 score on a scale | Standard Deviation 3.86 |
| NCI QuitGuide | Psychotic Symptoms | Negative symptoms | 12.23 score on a scale | Standard Deviation 5.23 |
Secondary
Psychotic Symptoms
Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.
Time frame: 2 month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Learn to Quit | Psychotic Symptoms | Positive symptoms | 11.55 score on a scale | Standard Deviation 3.49 |
| Learn to Quit | Psychotic Symptoms | Negative symptoms | 12.45 score on a scale | Standard Deviation 4.42 |
| NCI QuitGuide | Psychotic Symptoms | Positive symptoms | 10.79 score on a scale | Standard Deviation 3.79 |
| NCI QuitGuide | Psychotic Symptoms | Negative symptoms | 11.38 score on a scale | Standard Deviation 5.38 |
Secondary
Psychotic Symptoms
Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.
Time frame: 1 month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Learn to Quit | Psychotic Symptoms | Positive symptoms | 11.74 score on a scale | Standard Deviation 3.43 |
| Learn to Quit | Psychotic Symptoms | Negative symptoms | 11.61 score on a scale | Standard Deviation 4.38 |
| NCI QuitGuide | Psychotic Symptoms | Positive symptoms | 11.85 score on a scale | Standard Deviation 3.52 |
| NCI QuitGuide | Psychotic Symptoms | Negative symptoms | 10.81 score on a scale | Standard Deviation 4.33 |
Secondary
Psychotic Symptoms
Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.
Time frame: 3 month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Learn to Quit | Psychotic Symptoms | Positive symptoms | 11.10 score on a scale | Standard Deviation 4.21 |
| Learn to Quit | Psychotic Symptoms | Negative symptoms | 12.57 score on a scale | Standard Deviation 5.82 |
| NCI QuitGuide | Psychotic Symptoms | Positive symptoms | 12.32 score on a scale | Standard Deviation 5 |
| NCI QuitGuide | Psychotic Symptoms | Negative symptoms | 12.25 score on a scale | Standard Deviation 5.08 |
Secondary
Smoking Cravings
Average daily smoking cravings as self-reported through each smartphone app. Cravings range from a score of 1 to 10 with higher scores indicating higher cravings to smoke.
Time frame: Daily throughout study duration, 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Learn to Quit | Smoking Cravings | 6.13 units on a scale | Standard Deviation 2.25 |
| NCI QuitGuide | Smoking Cravings | 4.55 units on a scale | Standard Deviation 2.98 |