Clinical trial NCT03519451: Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment
Official title: Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment - A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Tobacco Use Disorder
Current Every Day Smoker
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-05-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: KickAsh group compliance with mood rating
timeFrame: Up to 8 weeks from start of study
measure: KickAsh group change in activity level
timeFrame: Up to 8 weeks from start of study
measure: KickAsh group user satisfaction
timeFrame: Up to 8 weeks from start of study
measure: Evidence of increased activity level in KickAsh and Breathe2Relax groups
timeFrame: Up to 8 weeks from start of study
measure: Evidence of improved mood in KickAsh and Breathe2Relax groups
timeFrame: Up to 8 weeks from start of study
measure: Evidence of greater smoking abstinence in KickAsh and Breathe2Relax groups
timeFrame: Up to 8 weeks from start of study
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jennifer A Minnix
role: PRINCIPAL_INVESTIGATOR
References: