App for Reducing Cravings to Smoke

Study Overview
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Brief Summary
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The overall goal of the study is to assess the efficacy of using cue exposure delivered via a smartphone application as an adjunct to Tobacco Quitline treatment to improve smoking abstinence.

Detailed Description
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The aims of the study are: (1) to update a recently developed study-related smartphone application to reduce cravings to smoke to be an engaging, user-friendly treatment tool, and verify user satisfaction; and (2) to test in a randomized controlled trial the efficacy of the app as an adjunct to quitline smoking cessation treatment in improving smoking abstinence compared to the quitline only.

Official Title
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Augmented Reality as an Adjunct to Quitline Counseling for Smoking Cessation

Conditions
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Smoking

Intervention / Treatment
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* Behavioral: Updating Existing Smartphone App
* Behavioral: Quitline Services
* Behavioral: Quitline Services and Smartphone App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age Daily smokers that have quit smoking within the past 3 months (Aim 1) or currently smoking ≥ 3 cigarettes per day for the past year (Aim 2) Functioning telephone number Owns a smart phone capable of supporting AR and willing to download the app Can speak, read and write in English Exclusion Criteria: Has another household member already enrolled in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aim 1: Update an existing smartphone App<br>An existing study app will be updated to be engaging, user-friendly treatment tool, and verify user satisfaction. | Behavioral: Quitline Services and Smartphone App<br>* In addition to quitline services, participants will download a study app that will allow them to track smoking urges and abstinence. After 48 hours of self-reported abstinence, those in the intervention group will be exposed to smoking extinction trials through the study smartphone app.<br>|
| Experimental: Aim 2: Quit Line Only<br>Participants randomized to this arm will receive usual care for smoking cessation via the quitline and a smartphone app that will allow them to track smoking urges and abstinence. | Behavioral: Quitline Services<br>* Quitline coaches use cognitive behavioral therapy, reinforcement, and principles of self-efficacy to promote effective behavior change. The quitline approach includes 5 key elements: setting a quit date, coping with triggers, effectively using medications, tobacco proofing, and social support. Individuals who enroll in the quitline's multi-call program receive phone calls and NRT.<br>|
| Experimental: Aim 2:Quitline plus smartphone App<br>Participants randomized to this arm will receive usual care for smoking cessation via the quitline and a smartphone app that will allow them to track smoking urges and abstinence. After 48 hours of self-reported abstinence, they will be exposed to smoking extinction trials through the study smartphone app. | Behavioral: Updating Existing Smartphone App<br>* Participants will be asked to use a recently developed study smartphone application to reduce cravings to smoke for a 1-week period. Through the app, participants will be exposed to smoking extinction trials daily. Participants will be encouraged and reminded to complete 2-5 extinction sessions per day. Each session will present 3-10 cues, and each cue will be presented for 30-60 seconds (average amount of extinction per day will be about 17 minutes). Participants will be encouraged to conduct the extinction sessions when high cravings are expected.<br>Behavioral: Quitline Services<br>* Quitline coaches use cognitive behavioral therapy, reinforcement, and principles of self-efficacy to promote effective behavior change. The quitline approach includes 5 key elements: setting a quit date, coping with triggers, effectively using medications, tobacco proofing, and social support. Individuals who enroll in the quitline's multi-call program receive phone calls and NRT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Usability Scale (Aim 1) | Participants' perception of usability and learnability of the app will be measured using 10 items on a 5-point Likert scale. Scores range from 0 to 100, with higher scores indicating better usability. | At 1 Week | 
| Tobacco Abstinence (Aim 2) | Self-report of no combustible tobacco use in the past 7 days | At 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User Satisfaction (Aim 1) | One Likert scale item will capture participants' satisfaction with the app. The Likert scale is from 1 to 4, with higher score indicating greater satisfaction. | At 1 Week |