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

April 10, 2026 updated by: M.D. Anderson Cancer Center

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Up to 8 weeks from start of study
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
Time Frame: Up to 8 weeks from start of study
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
Time Frame: Up to 8 weeks from start of study
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
Time Frame: Up to 8 weeks from start of study
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
Time Frame: Up to 8 weeks from start of study
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
Time Frame: Up to 8 weeks from start of study
Evidence of greater smoking abstinence determined by questionnaires, phone calls, and interview.
Up to 8 weeks from start of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

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)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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