Evaluating the Feasibility and Efficacy of a Real-time Smoking Intervention Using Wearable Technology

Study Overview
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Brief Summary
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This study will use wearable technology to test the feasibility and efficacy of delivering a novel real-time smoking intervention to improve standard tobacco treatment.

Detailed Description
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The goals of this project include evaluating the feasibility, acceptability, and helpfulness of the real-time smoking intervention and to assess the preliminary efficacy of the real-time intervention as an adjunct to standard tobacco treatment. Rates of adherence, participant satisfaction, and perceived usefulness will be evaluated through post-treatment interviews and ratings. Biochemically confirmed 7-day point prevalence abstinence will be compared between the experimental and control groups at the end of treatment (week 8).

Official Title
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Evaluating the Feasibility and Efficacy of a Real-time Smoking Intervention Using Wearable Technology

Conditions
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Tobacco Use Cessation

Intervention / Treatment
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* Behavioral: Real-Time Smoking Intervention
* Behavioral: Standard Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 or older Able to read English Cigarette smoker Seeking smoking cessation treatment Exclusion Criteria: Serious psychiatric or medical condition Unable or unwilling to complete study protocol

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel group randomized trial design comparing smoking outcomes when receiving standard treatment vs. standard treatment plus real-time smoking intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real-Time Smoking Intervention<br>Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment. | Behavioral: Real-Time Smoking Intervention<br>* Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.<br>Behavioral: Standard Treatment<br>* Adult smokers will receive standard outpatient tobacco treatment.<br>|
| Active Comparator: Standard Treatment<br>Adult smokers will receive standard outpatient tobacco treatment. | Behavioral: Standard Treatment<br>* Adult smokers will receive standard outpatient tobacco treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cigarettes | Self-reported cigarette use (Timeline follow-back data) during the 8-week study to estimate effect sizes between groups. | Baseline and Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Days Abstinent From Cigarettes | Timeline follow-back data will be collected to determine the % of days abstinent from cigarettes. | Week 8 |