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Clinical Trials/NCT03519451
NCT03519451
Active, not recruiting
Not Applicable

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

M.D. Anderson Cancer Center1 site in 1 country24 target enrollmentStarted: April 25, 2018Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
24
Locations
1
Primary Endpoint
KickAsh group compliance with mood rating

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Group I (KickAsh smartphone mobile application)

Experimental

Participants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks.

Intervention: Internet-Based Intervention (Other)

Group I (KickAsh smartphone mobile application)

Experimental

Participants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks.

Intervention: Questionnaire Administration (Other)

Group II (Breathe2Relax smartphone mobile application)

Experimental

Participants receive Breathe2Relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks.

Intervention: Internet-Based Intervention (Other)

Group II (Breathe2Relax smartphone mobile application)

Experimental

Participants receive Breathe2Relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks.

Intervention: Questionnaire Administration (Other)

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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