Goal2Quit + NRT Sampling

Study Overview
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Brief Summary
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The goal of this work is to develop, systematically evaluate, and clinically test an integrated cessation intervention comprised of a depression-specific Behavioral Activation (BA) for cessation mobile app (Goal2Quit) packaged with nicotine replacement therapy (NRT) sampling. This integrated intervention will address the need for an easily disseminable, evidence-based, depression-specific cessation intervention for delivery via primary care.

Official Title
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Development and Testing of a Depression-Specific Behavioral Activation Mobile App Paired With Nicotine Replacement Therapy Sampling for Smoking Cessation Treatment Via Primary Care

Conditions
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Cigarette Smoking, Smoking Cessation, Depression

Intervention / Treatment
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* Behavioral: Treatment as Usual
* Combination Product: Goal2Quit + NRT Sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current elevated depressive symptoms defined as a score of > 10 (at least mild depression) on the Patient Health Questionnaire-8 (PHQ-8) Current smoking, defined as smoking 10+ cigarettes/day, for 25+ days out of the last 30, for the last 6+ months Ownership of an Android or iOS smartphone Age 18+ Possess a valid e-mail address that is checked daily to access follow-up assessments English fluency Exclusion Criteria: - Contraindications for NRT (pregnancy/intention to become pregnant/breastfeeding, recent cardiovascular trauma/uncontrolled hypertension) - Severe visual impairment, which may limit ability to utilize an app

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment As Usual<br>Participants in the Treatment As Usual condition will receive educational material on quitting smoking. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment. | Behavioral: Treatment as Usual<br>* Participants in the Treatment As Usual condition will receive educational material on quitting smoking. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.<br>|
| Experimental: Goal2Quit + NRT Sampling<br>Participants in the Goal2Quit + NRT Sampling condition will receive a download code to download the Goal2Quit mobile application. Goal2Quit is a mobile app for cigarette smokers with elevated symptoms of depression. Within the app, users identify values, create activities, schedule activities, rate mood daily, and track cigarette smoking. Participants in Group B will also receive a two-week starter kit sample of nicotine replacement therapy (NRT; 14mg patch and 4mg lozenge). Participants will be asked to utilize Goal2Quit regularly, at least once per day, as well as the NRT sample in an attempt to quit smoking. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment. | Combination Product: Goal2Quit + NRT Sampling<br>* Participants in the Goal2Quit + NRT Sampling condition will receive a download code to download the Goal2Quit mobile application. Goal2Quit is a mobile app for cigarette smokers with elevated symptoms of depression. Within the app, users identify values, create activities, schedule activities, rate mood daily, and track cigarette smoking. Participants in Group B will also receive a two-week starter kit sample of nicotine replacement therapy (NRT; 14mg patch and 4mg lozenge). Participants will be asked to utilize Goal2Quit regularly, at least once per day, as well as the NRT sample in an attempt to quit smoking. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7 Day Point Prevalence Abstinence | Patients will self report smoking status (yes/no) for the seven days preceding the 12-week follow-up assessment. The data reported is based on the participants that reported yes. | From 7 days preceding the 12-week follow-up assessment through the 12-week follow-up assessment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Score of Depressive Symptoms | Patients will self report depressive symptoms weekly for 8 weeks with final follow-up at 12-weeks via the Beck Depression Inventory-II. The range of scores possible are 0 - 63, where lower scores are indicative of lower symptoms of depression. | Change in BDI from baseline to Week 12 |