Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment

Not Applicable

Active, not recruiting

• Conditions: Current Every Day Smoker; Tobacco Use Disorder; Depression
• Interventions: Other: Internet-Based Intervention; Other: Questionnaire Administration

• Registration Number: NCT03519451
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

This trial studies how well smartphone mobile applications work in enhancing smoking cessation treatment in current smokers. Smartphone mobile applications may help current smokers quit smoking.

Detailed Description

PRIMARY OBJECTIVES:

I. To test the acceptability and preliminary efficacy of a smartphone health application (app), Kick Ash, which will incorporate brief behavioral activation versus (vs.) a relaxation app, Breathe2Relax in a small randomized controlled trial of smokers with elevated depressive symptoms.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks.

GROUP II: Participants receive Breathe2Relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks.

Study Timeline

• Study Start: 2018-04-25
• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-04-26
• Study First Posted: 2018-05-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• MD Anderson patient between the ages of 18 to 65
• Current smoker (i.e., at least 1 cigarette or e-cigarette per day)
• Smoking for at least one year
• Willing to set a quit date in the next 30 days
• Not engaged in smoking cessation treatment other than the MDACC Tobacco Treatment Program
• Currently elevated depressive symptoms or a history of elevated depressive symptoms; (PHQ 2 = or > 1); current or past
• English speaking and ability to read and comprehend English
• Currently own an iOS mobile phone or tablet (iPhone; iPad) using iOS 9.0 or later and reports regular use (at least weekly) of at least 1 iOS app

Exclusion Criteria

• Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator or Collaborator
• Subject considered by the investigator an unsuitable candidate for receipt of a smoking cessation treatment or unstable to be followed up throughout the entire duration of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (KickAsh smartphone mobile application)	Questionnaire Administration	Participants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks.
Group II (Breathe2Relax smartphone mobile application)	Questionnaire Administration	Participants receive Breathe2Relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks.
Group I (KickAsh smartphone mobile application)	Internet-Based Intervention	Participants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks.
Group II (Breathe2Relax smartphone mobile application)	Internet-Based Intervention	Participants receive Breathe2Relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks.

Primary Outcome Measures

Name	Time	Method
KickAsh group compliance with mood rating	Up to 8 weeks from start of study	KickAsh group compliance with mood rating determined by questionnaires, phone calls, and interview.
Evidence of increased activity level in KickAsh and Breathe2Relax groups	Up to 8 weeks from start of study	Increase in activity level determined by questionnaires, phone calls, and interview.
Evidence of greater smoking abstinence in KickAsh and Breathe2Relax groups	Up to 8 weeks from start of study	Evidence of greater smoking abstinence determined by questionnaires, phone calls, and interview.
KickAsh group change in activity level	Up to 8 weeks from start of study	KickAsh group change in activity level determined by questionnaires, phone calls, and interview.
KickAsh group user satisfaction	Up to 8 weeks from start of study	KickAsh group user satisfaction determined by questionnaires, phone calls, and interview.
Evidence of improved mood in KickAsh and Breathe2Relax groups	Up to 8 weeks from start of study	Evidence of improved mood determined by questionnaires, phone calls, and interview.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States