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

Nicotine Addiction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03069482
• Other study ID #: Pro00075165
• Secondary ID: 4R00DA037276-03
• Status: Completed
• Phase: Phase 1
• Start date: May 15, 2017
• Est. completion date: January 17, 2019

Study information

• Verified date: October 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 17, 2019
• Est. primary completion date: January 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Mental Disorders
• Nicotine Addiction
• Serious Mental Illness

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of App Use	Frequency of app openings in each group	Daily throughout study duration, 4 months
Primary	Duration of App Use	Mean duration of app use in each group over the course of study participation (4 months)	Daily throughout study duration, 4 months
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.	Approximately 15 months
Primary	Feasibility as Measured by Study Attrition	Number and percentage of subjects who complete 4-month follow up assessment	4-months
Primary	Recruitment Yield Effort	Percent of subjects responding to ads and clinician referrals	Approximately 15 months
Primary	Feasibility of Measurement Strategy	Percent completion of assessment measures. Assessment measures include surveys, questionnaires, and cognitive tasks.	Approximately 19 months
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.	1-month follow-up
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.	2-month follow-up
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.	3-month follow-up
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.	4-month follow-up
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.	1 month follow-up
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.	2 month follow-up
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.	3 month follow-up
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.	4 month follow-up
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	1 month follow up
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	2 month follow up
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.	3 month follow up
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.	4 month follow up
Secondary	30-day Point Prevalence Abstinence Rates	Participants who self-reported not smoking for 30 days prior to the specified timepoint.	1 month follow up
Secondary	30-day Point Prevalence Abstinence Rates	Participants who self-reported not smoking for 30 days prior to the specified timepoint.	2 month follow up
Secondary	30-day Prevalence Abstinence Rates	Participants who self-reported not smoking for 30 days prior to the specified timepoint.	3 month follow up
Secondary	30-day Point Prevalence Abstinence Rates	Participants who self-reported not smoking for 30 days prior to the specified timepoint.	4 month follow up
Secondary	7-day Point Prevalence Abstinence	Participants who self-reported not smoking for 7 days prior to the specified timepoint.	1 month follow up
Secondary	7-day Point Prevalence Abstinence	Participants who self-reported not smoking for 7 days prior to the specified timepoint.	2 month follow up
Secondary	7-day Point Prevalence Abstinence	Participants who self-reported not smoking for 7 days prior to the specified timepoint.	3 month follow up
Secondary	7-day Point Prevalence Abstinence	Participants who self-reported not smoking for 7 days prior to the specified timepoint.	4 month follow up
Secondary	24-hour Point Prevalence Abstinence	Participants who self-reported not smoking for 24 hours prior to the specified timepoint.	1 month follow up
Secondary	24-hour Point Prevalence Abstinence	Participants who self-reported not smoking for 24 hours prior to the specified timepoint.	2 month follow up
Secondary	24-hour Point Prevalence Abstinence	Participants who self-reported not smoking for 24 hours prior to the specified timepoint.	3 month follow up
Secondary	24-hour Point Prevalence Abstinence	Participants who self-reported not smoking for 24 hours prior to the specified timepoint.	4 month follow up
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.	1 month follow up
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.	2 month follow up
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.	3 month follow up
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.	4 month follow up
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"	Baseline to 1, 2, 3 and 4 month follow up
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.	Baseline to 1, 2, 3 and 4 month follow up
Secondary	Nicotine Replacement Patch Utilization	Days of patch use over the last 30 days.	1 month follow up
Secondary	Nicotine Replacement Patch Utilization	Days of patch use over the last 30 days.	2 month follow up
Secondary	Nicotine Replacement Patch Utilization	Days of patch use over the last 30 days.	3 month follow up
Secondary	Nicotine Replacement Patch Utilization	Days of patch use over the last 30 days.	4 month follow up
Secondary	Nicotine Replacement Lozenge Utilization	Days of lozenge use over the last 30 days.	1 month follow up
Secondary	Nicotine Replacement Lozenge Utilization	Days of lozenge use over the last 30 days.	2 month follow up
Secondary	Nicotine Replacement Lozenge Utilization	Days of lozenge use over the last 30 days.	3 month follow up
Secondary	Nicotine Replacement Lozenge Utilization	Days of lozenge use over the last 30 days.	4 month follow up
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.	Daily throughout study duration, 4 months
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.	Daily throughout study, 4 months
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.	Daily throughout study duration, 4 months
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.	1 month follow up
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.	2 month follow up
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.	3 month follow up
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.	4 month follow up
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.	1 month follow up
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.	2 month follow up
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.	3 month follow up
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.	4 month follow up