Goal2Quit + NRT Sampling

Not Applicable

Completed

• Conditions: Cigarette Smoking; Smoking Cessation; Depression
• Interventions: Combination Product: Goal2Quit + NRT Sampling; Behavioral: Treatment as Usual

• Registration Number: NCT03837379
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-06
• Study First Submitted QC: 2019-02-08
• Study First Posted: 2019-02-12
• Study Start: 2020-06-22
• Primary Completion: 2022-05-18
• Study Completion: 2022-05-18
• Results First Submitted: 2023-03-31
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-24
• Last Update Submitted: 2023-04-24
• Results First Posted: 2023-05-17
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Goal2Quit + NRT Sampling	Goal2Quit + NRT Sampling	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.
Treatment As Usual	Treatment as Usual	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.

Primary Outcome Measures

Name	Time	Method
7 Day Point Prevalence Abstinence	From 7 days preceding the 12-week follow-up assessment through the 12-week follow-up assessment.	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.

Secondary Outcome Measures

Name	Time	Method
Mean Score of Depressive Symptoms	Change in BDI from baseline to Week 12	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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States