Goal2Quit + NRT Sampling

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

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 Overview

• Status: Completed
• Conditions: Depression; Smoking Cessation; Cigarette Smoking
• Intervention / Treatment: Behavioral: Treatment as Usual; Combination product: Goal2Quit + NRT Sampling

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Behavioral: 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.
Experimental: 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.	Combination product: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Jennifer Dahne, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2020
• Primary Completion (Actual): May 18, 2022
• Study Completion (Actual): May 18, 2022

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 00074015; K23DA045766 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No