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Active, Not Recruiting

NCT Number: NCT03519451

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Depression Behavior Behavioral Symptoms Chemically-Induced Disorders Current Every Day Smoker Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-Based Intervention

Other

Given KickAsh smartphone mobile application

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
May 9, 2018
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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