Goal2Quit + NRT Sampling

NCT03837379 | Completed Results

• 2 other identifiers: 00074015K23DA045766
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking; Smoking Cessation; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Score of Depressive Symptoms

  Change in BDI from baseline to Week 12

Study Arms (2)

Treatment As Usual

OTHER

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

Goal2Quit + NRT Sampling

EXPERIMENTAL

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

Interventions

Treatment as Usual 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.

Treatment As Usual

Goal2Quit + NRT Sampling 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.

Goal2Quit + NRT Sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Dahne J, Wahlquist AE, Kustanowitz J, Natale N, Fahey M, Graboyes EM, Diaz VA, Carpenter MJ. Behavioral Activation-Based Digital Smoking Cessation Intervention for Individuals With Depressive Symptoms: Randomized Clinical Trial. J Med Internet Res. 2023 Nov 1;25:e49809. doi: 10.2196/49809.

  PMID: 37910157 DERIVED

MeSH Terms

Conditions

Cigarette Smoking; Smoking Cessation; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior; Behavioral Symptoms

Results Point of Contact

• Title: Dr. Jennifer Dahne
• Organization: Medical University of South Carolina

dahne@musc.edu

843-876-2280

Study Officials

• Jennifer Dahne, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 12, 2019
• Study Start: June 22, 2020
• Primary Completion: May 18, 2022
• Study Completion: May 18, 2022
• Last Updated: May 17, 2023
• Results First Posted: May 17, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)