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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03069482
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Nicotine Addiction Serious Mental Illness Device: Learn to Quit App Drug: Nicotine patch Drug: Nicotine lozenge Behavioral: Technical Coaching Device: NCI QuitGuide App

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 GuitGuide 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
Device: Learn 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.
Drug: Nicotine 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.
Drug: Nicotine 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.
Behavioral: Technical 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.
Active Comparator: NCI QuitGuide
A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.
Drug: Nicotine 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.
Drug: Nicotine 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.
Behavioral: Technical 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.
Device: NCI 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).


Outcome Measures

Primary Outcome Measures :
  1. Frequency of app use [ Time Frame: Daily throughout study duration, 4 months ]
    Frequency of app openings in each group

  2. Time of app use [ Time Frame: Daily throughout study duration, 4 months ]
    Time of app use in each group

  3. Feasibility as measured by study accrual relative to recruitment goal [ Time Frame: Approximately 15 months ]
    Percent of subjects enrolled relative to recruitment goal (N=90)

  4. Feasibility as measured by study attrition [ Time Frame: Approximately 19 months ]
    Percent 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

  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 Outcome Measures :
  1. Biochemically confirmed prolonged abstinence rates [ Time Frame: 1 month follow up ]
    Percent of subjects in each group reporting abstinence. 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

  2. Biochemically confirmed prolonged abstinence rates [ Time Frame: 2 month follow up ]
    Percent of subjects in each group reporting abstinence. 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

  3. Biochemically confirmed prolonged abstinence rates [ Time Frame: 3 month follow up ]
    Percent of subjects in each group reporting abstinence. 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

  4. Biochemically confirmed prolonged abstinence rates [ Time Frame: 4 month follow up ]
    Percent of subjects in each group reporting abstinence. 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

  5. 30-day, 7-day, & 24-hour point prevalence abstinence rates [ Time Frame: 1 month follow up ]
    Percent of subjects in each group who self-reported not smoking any tobacco product at all during the corresponding time frame period

  6. 30-day, 7-day, & 24-hour point prevalence abstinence rates [ Time Frame: 2 month follow up ]
    Percent of subjects in each group who self-reported not smoking any tobacco product at all during the corresponding time frame period

  7. 30-day, 7-day, & 24-hour point prevalence abstinence rates [ Time Frame: 3 month follow up ]
    Percent of subjects in each group who self-reported not smoking any tobacco product at all during the corresponding time frame period

  8. 30-day, 7-day, & 24-hour point prevalence abstinence rates [ Time Frame: 4 month follow up ]
    Percent of subjects in each group who self-reported not smoking any tobacco product at all during the corresponding time frame period

  9. Quit Attempts [ Time Frame: 1 month follow up ]
    Number of quit attempts defined as self-reported no smoking at all for 24 hours

  10. Quit Attempts [ Time Frame: 2 month follow up ]
    Number of quit attempts defined as self-reported no smoking at all for 24 hours

  11. Quit Attempts [ Time Frame: 3 month follow up ]
    Number of quit attempts defined as self-reported no smoking at all for 24 hours

  12. Quit Attempts [ Time Frame: 4 month follow up ]
    Number of quit attempts defined as self-reported no smoking at all for 24 hours

  13. 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"

  14. Change in number of average cigarettes smoked per day [ Time Frame: Baseline to 1, 2, 3 and 4 month follow up ]
    Participants will self-report average number of cigarettes smoked in the past week

  15. Nicotine replacement patch utilization [ Time Frame: 1 month follow up ]
    Percent of subjects in each group self-reporting adherence to patch directions

  16. Nicotine replacement patch utilization [ Time Frame: 2 month follow up ]
    Percent of subjects in each group self-reporting adherence to patch directions

  17. Nicotine replacement patch utilization [ Time Frame: 3 month follow up ]
    Percent of subjects in each group self-reporting adherence to patch directions

  18. Nicotine replacement patch utilization [ Time Frame: 4 month follow up ]
    Percent of subjects in each group self-reporting adherence to patch directions

  19. Nicotine replacement lozenge utilization [ Time Frame: 1 month follow up ]
    Percent of subjects in each group self-reporting adherence to nicotine lozenge directions

  20. Nicotine replacement lozenge utilization [ Time Frame: 2 month follow up ]
    Percent of subjects in each group self-reporting adherence to nicotine lozenge directions

  21. Nicotine replacement lozenge utilization [ Time Frame: 3 month follow up ]
    Percent of subjects in each group self-reporting adherence to nicotine lozenge directions

  22. Nicotine replacement lozenge utilization [ Time Frame: 4 month follow up ]
    Percent of subjects in each group self-reporting adherence to nicotine lozenge directions

  23. Affect [ Time Frame: Daily throughout study duration, 4 months ]
    Mood ratings as self-reported through each smartphone app

  24. Smoking cravings [ Time Frame: Daily throughout study duration, 4 months ]
    Smoking cravings as self-reported through each smartphone app

  25. Psychotic symptoms [ Time Frame: 1 month follow up ]
    Percent of subjects in each group with clinically interfering psychotic symptoms as determined by the Positive and Negative Syndrome Scale for Schizophrenia

  26. Psychotic symptoms [ Time Frame: 2 month follow up ]
    Percent of subjects in each group with clinically interfering psychotic symptoms as determined by the Positive and Negative Syndrome Scale for Schizophrenia

  27. Psychotic symptoms [ Time Frame: 3 month follow up ]
    Percent of subjects in each group with clinically interfering psychotic symptoms as determined by the Positive and Negative Syndrome Scale for Schizophrenia

  28. Psychotic symptoms [ Time Frame: 4 month follow up ]
    Percent of subjects in each group with clinically interfering psychotic symptoms as determined by the Positive and Negative Syndrome Scale for Schizophrenia

  29. Non-psychotic psychiatric symptoms [ Time Frame: 1 month follow up ]
    Percent of subjects in each group with clinically interfering psychotic symptoms as determined by the Brief Symptom Inventory

  30. Non-psychotic psychiatric symptoms [ Time Frame: 2 month follow up ]
    Percent of subjects in each group with clinically interfering psychotic symptoms as determined by the Brief Symptom Inventory

  31. Non-psychotic psychiatric symptoms [ Time Frame: 3 month follow up ]
    Percent of subjects in each group with clinically interfering psychotic symptoms as determined by the Brief Symptom Inventory

  32. Non-psychotic psychiatric symptoms [ Time Frame: 4 month follow up ]
    Percent of subjects in each group with clinically interfering psychotic symptoms as determined by the Brief Symptom Inventory


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03069482


Contacts
Contact: Javier Rizo, BA 919.681.3493 javier.rizo@duke.edu
Contact: Roger Vilardaga, PhD 919.681.3441 roger.vilardaga@duke.edu

Locations
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Javier L Rizo, BA    919-681-3493    javier.rizo@duke.edu   
Contact: Roger M Vilardaga, PhD    919-681-3441    roger.vilardaga@duke.edu   
Sponsors and Collaborators
Duke University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Roger Vilardaga, PhD Duke University
More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03069482     History of Changes
Other Study ID Numbers: Pro00075165
4R00DA037276-03 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
Smoking
mHealth
Serious Mental Illness
Acceptance and Commitment Therapy
US DHHS Clinical Practice Guidelines

Additional relevant MeSH terms:
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action