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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression, Tobacco Use Disorder, Current Every Day Smoker

Intervention / Treatment
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* Other: Internet-Based Intervention
* Other: Internet-Based Intervention
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |