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

Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment - A Pilot Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Tobacco Use Disorder; Current Every Day Smoker
• Intervention / Treatment: Other: Questionnaire Administration; Other: Internet-Based Intervention; Other: Internet-Based Intervention

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (KickAsh smartphone mobile application); Participants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks.	Other: Questionnaire Administration; Ancillary studies; Other: Internet-Based Intervention; Given KickAsh smartphone mobile application; Other: Internet-Based Intervention; Given Breathe2Relax smartphone mobile application
Experimental: Group II (Breathe2Relax smartphone mobile application); Participants receive Breathe2Relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks.	Other: Questionnaire Administration; Ancillary studies; Other: Internet-Based Intervention; Given KickAsh smartphone mobile application; Other: Internet-Based Intervention; Given Breathe2Relax smartphone mobile application

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jennifer A Minnix, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: April 26, 2018
• First Posted (Actual): May 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 2017-0720 (Other Identifier: M D Anderson Cancer Center); NCI-2018-01158 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R43CA206682 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes