Goal2Quit + NRT Sampling

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-22

Study Completion Date

2022-05-18

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.

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Detailed Description

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Conditions

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Cigarette Smoking Smoking Cessation Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Treatment as Usual

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Goal2Quit + NRT Sampling

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type COMBINATION_PRODUCT

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No