Smoking
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALUpdating Existing Smartphone App
Participants will be asked to use a recently developed study smartphone application to reduce cravings to smoke for a 5-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 3-8 cues, and each cue will be presented for 20-40 seconds (average amount of extinction per day will be about 10 minutes). Participants will be encouraged to conduct the extinction sessions when high cravings are expected.
BEHAVIORALQuitline Services
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.
BEHAVIORALQuitline Services and Smartphone App
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.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The statistician is masked
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (Aim 1) | At 1 Week | 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. |
| Tobacco Abstinence (Aim 2) | At 6 Months | Self-report of no combustible tobacco use in the past 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| User Satisfaction (Aim 1) | At 1 Week | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristine Vinci, PhD
Moffitt Cancer Center
Outcome results
None listed