Current Every Day Smoker, Depression, Tobacco Use Disorder
Conditions
Brief 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.
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.
Interventions
OTHERInternet-Based Intervention
Given KickAsh smartphone mobile application
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KickAsh group compliance with mood rating | Up to 8 weeks from start of study | KickAsh group compliance with mood rating determined by questionnaires, phone calls, and interview. |
| KickAsh group change in activity level | Up to 8 weeks from start of study | KickAsh group change in activity level determined by questionnaires, phone calls, and interview. |
| KickAsh group user satisfaction | Up to 8 weeks from start of study | KickAsh group user satisfaction determined by questionnaires, phone calls, and interview. |
| Evidence of increased activity level in KickAsh and Breathe2Relax groups | Up to 8 weeks from start of study | Increase in activity level determined by questionnaires, phone calls, and interview. |
| Evidence of improved mood in KickAsh and Breathe2Relax groups | Up to 8 weeks from start of study | Evidence of improved mood determined by questionnaires, phone calls, and interview. |
| Evidence of greater smoking abstinence in KickAsh and Breathe2Relax groups | Up to 8 weeks from start of study | Evidence of greater smoking abstinence determined by questionnaires, phone calls, and interview. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJennifer A Minnix
M.D. Anderson Cancer Center
Outcome results
None listed