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Completed

NCT Number: NCT03069482

Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness

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.

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Key information

Conditions

Nicotine Addiction Behavior Chemically-Induced Disorders Mental Disorders Serious Mental Illness Smoking Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duke University

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Learn to Quit App

Device

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.

Nicotine patch

Drug

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.

Nicotine Lozenge

Drug

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.

Technical Coaching

Behavioral

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.

NCI QuitGuide App

Device

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).

Primary outcomes

  1. Days of App Use

    Time frame: Daily throughout study duration, 4 months

    Frequency of app openings in each group

  2. Duration of App Use

    Time frame: Daily throughout study duration, 4 months

    Mean duration of app use in each group over the course of study participation (4 months)

  3. Feasibility as Measured by Study Accrual Relative to Recruitment Goal

    Time frame: 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.

  4. Feasibility as Measured by Study Attrition

    Time frame: 4-months

    Number and percentage of subjects who complete 4-month follow up assessment

  5. Recruitment Yield Effort

    Time frame: Approximately 15 months

    Percent of subjects responding to ads and clinician referrals

  6. Feasibility of Measurement Strategy

    Time frame: Approximately 19 months

    Percent completion of assessment measures. Assessment measures include surveys, questionnaires, and cognitive tasks.

  7. Usability of App Design as Measured by the System Usability Scale (SUS)

    Time frame: 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.

  8. Usability of App Design as Measured by the System Usability Scale (SUS)

    Time frame: 2-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.

  9. Usability of App Design as Measured by the System Usability Scale (SUS)

    Time frame: 3-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.

  10. Usability of App Design as Measured by the System Usability Scale (SUS)

    Time frame: 4-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 outcomes

  1. Biochemically Confirmed 7-day Point Prevalence Abstinence

    Time frame: 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.

  2. Biochemically Confirmed 7-day Point Prevalence Abstinence

    Time frame: 2 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.

  3. Biochemically Confirmed 7-day Point Prevalence Abstinence

    Time frame: 3 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.

  4. Biochemically Confirmed 7-day Point Prevalence Abstinence

    Time frame: 4 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.

  5. Biochemically Confirmed Prolonged Abstinence Rates

    Time frame: 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

  6. Biochemically Confirmed Prolonged Abstinence Rates

    Time frame: 2 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

  7. Biochemically Confirmed Prolonged Abstinence Rates

    Time frame: 3 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.

  8. Biochemically Confirmed Prolonged Abstinence Rates

    Time frame: 4 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.

  9. 30-day Point Prevalence Abstinence Rates

    Time frame: 1 month follow up

    Participants who self-reported not smoking for 30 days prior to the specified timepoint.

  10. 30-day Point Prevalence Abstinence Rates

    Time frame: 2 month follow up

    Participants who self-reported not smoking for 30 days prior to the specified timepoint.

  11. 30-day Prevalence Abstinence Rates

    Time frame: 3 month follow up

    Participants who self-reported not smoking for 30 days prior to the specified timepoint.

  12. 30-day Point Prevalence Abstinence Rates

    Time frame: 4 month follow up

    Participants who self-reported not smoking for 30 days prior to the specified timepoint.

  13. 7-day Point Prevalence Abstinence

    Time frame: 1 month follow up

    Participants who self-reported not smoking for 7 days prior to the specified timepoint.

  14. 7-day Point Prevalence Abstinence

    Time frame: 2 month follow up

    Participants who self-reported not smoking for 7 days prior to the specified timepoint.

  15. 7-day Point Prevalence Abstinence

    Time frame: 3 month follow up

    Participants who self-reported not smoking for 7 days prior to the specified timepoint.

  16. 7-day Point Prevalence Abstinence

    Time frame: 4 month follow up

    Participants who self-reported not smoking for 7 days prior to the specified timepoint.

  17. 24-hour Point Prevalence Abstinence

    Time frame: 1 month follow up

    Participants who self-reported not smoking for 24 hours prior to the specified timepoint.

  18. 24-hour Point Prevalence Abstinence

    Time frame: 2 month follow up

    Participants who self-reported not smoking for 24 hours prior to the specified timepoint.

  19. 24-hour Point Prevalence Abstinence

    Time frame: 3 month follow up

    Participants who self-reported not smoking for 24 hours prior to the specified timepoint.

  20. 24-hour Point Prevalence Abstinence

    Time frame: 4 month follow up

    Participants who self-reported not smoking for 24 hours prior to the specified timepoint.

  21. Average Number of Quit Attempts Per Arm

    Time frame: 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.

  22. Average Number of Quit Attempts Per Arm

    Time frame: 2 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.

  23. Average Number of Quit Attempts Per Arm

    Time frame: 3 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.

  24. Average Number of Quit Attempts Per Arm

    Time frame: 4 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.

  25. Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence

    Time frame: 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"

  26. Change in Average Number of Cigarettes Smoked Per Day

    Time frame: 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.

  27. Nicotine Replacement Patch Utilization

    Time frame: 1 month follow up

    Days of patch use over the last 30 days.

  28. Nicotine Replacement Patch Utilization

    Time frame: 2 month follow up

    Days of patch use over the last 30 days.

  29. Nicotine Replacement Patch Utilization

    Time frame: 3 month follow up

    Days of patch use over the last 30 days.

  30. Nicotine Replacement Patch Utilization

    Time frame: 4 month follow up

    Days of patch use over the last 30 days.

  31. Nicotine Replacement Lozenge Utilization

    Time frame: 1 month follow up

    Days of lozenge use over the last 30 days.

  32. Nicotine Replacement Lozenge Utilization

    Time frame: 2 month follow up

    Days of lozenge use over the last 30 days.

  33. Nicotine Replacement Lozenge Utilization

    Time frame: 3 month follow up

    Days of lozenge use over the last 30 days.

  34. Nicotine Replacement Lozenge Utilization

    Time frame: 4 month follow up

    Days of lozenge use over the last 30 days.

  35. Affect Ratings - Learn to Quit

    Time frame: 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.

  36. Affect Ratings - QuitGuide

    Time frame: 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.

  37. Smoking Cravings

    Time frame: 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.

  38. Psychotic Symptoms

    Time frame: 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.

  39. Psychotic Symptoms

    Time frame: 2 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.

  40. Psychotic Symptoms

    Time frame: 3 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.

  41. Psychotic Symptoms

    Time frame: 4 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.

  42. General Psychiatric Symptoms

    Time frame: 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.

  43. General Psychiatric Symptoms

    Time frame: 2 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.

  44. General Psychiatric Symptoms

    Time frame: 3 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.

  45. General Psychiatric Symptoms

    Time frame: 4 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2017
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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