Goal2Quit + NRT Sampling

Medical University of South Carolina164 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

164

Conditions

Cigarette Smoking Smoking Cessation Depression

Interventions

Treatment as UsualBEHAVIORAL

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 SamplingCOMBINATION_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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: From 7 days preceding the 12-week follow-up assessment through the 12-week follow-up assessment.

Secondary Outcomes

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.

Time frame: Change in BDI from baseline to Week 12

Data from ClinicalTrials.gov

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