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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03519451
• Other study ID #: 2017-0720
• Secondary ID: NCI-2018-0115820
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 25, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Current Every Day Smoker
• Depression
• Tobacco Use Disorder

Intervention

Other:
• Internet-Based Intervention
Given KickAsh smartphone mobile application
• Internet-Based Intervention
Given Breathe2Relax smartphone mobile application
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	KickAsh group user satisfaction	KickAsh group user satisfaction determined by questionnaires, phone calls, and interview.	Up to 8 weeks from start of study
Primary	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
Primary	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
Primary	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

External Links

•   MD Anderson Cancer Center Website