DepressionNCT03519451
Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment
A study testing Internet-Based Intervention and Questionnaire Administration in people with Depression and Tobacco Use Disorder, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Tobacco Use Disorder, Current Every Day Smoker
- What is being tested?
- Internet-Based Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2018to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment - A Pilot Study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Depression, Tobacco Use Disorder, Current Every Day Smoker
- Being tested
- Internet-Based Intervention, Questionnaire Administration
- Medical subject headings
- Depression, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based InterventionOther
Given KickAsh smartphone mobile application
Internet-Based InterventionOther
Given Breathe2Relax smartphone mobile application
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (KickAsh smartphone mobile application) | Experimental | Participants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks. Receives: Other: Internet-Based Intervention; Other: Questionnaire Administration |
| 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. Receives: Other: Internet-Based Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
KickAsh group compliance with mood rating
KickAsh group compliance with mood rating determined by questionnaires, phone calls, and interview.
Measured: 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.
Measured: Up to 8 weeks from start of study
KickAsh group user satisfaction
KickAsh group user satisfaction determined by questionnaires, phone calls, and interview.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 8 weeks from start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start25 Apr 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jennifer A Minnix, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519451
- Sponsor's protocol ID
- 2017-0720
- Other IDs
- NCI-2018-01158, 2017-0720, R43CA206682
- Status last verified
- Oct 2026
- First submitted
- 26 Apr 2018
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Smartphone Mobile Application (App) to Enhance Smoking Cessation Treatment - A Pilot Study
- ClinicalTrials.gov ID
- NCT03519451
- Acronym / sponsor ID
- 2017-0720
- Conditions
- Depression, Tobacco Use Disorder, Current Every Day Smoker
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (KickAsh smartphone mobile application) | Experimental | Other: Internet-Based Intervention, Other: Questionnaire AdministrationParticipants receive KickAsh smartphone mobile application designed to help the learning of relaxation skills over 8 weeks. |
| Group II (Breathe2Relax smartphone mobile application) | Experimental | Other: Internet-Based Intervention, Other: Questionnaire AdministrationParticipants receive Breathe2Relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based InterventionGiven KickAsh smartphone mobile application | Other | Group I (KickAsh smartphone mobile application) |
| Internet-Based InterventionGiven Breathe2Relax smartphone mobile application | Other | Group II (Breathe2Relax smartphone mobile application) |
| Questionnaire AdministrationAncillary studies | Other | Group I (KickAsh smartphone mobile application), Group II (Breathe2Relax smartphone mobile application) |
Primary outcome
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.
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 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 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer A Minnix principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Intervention and Questionnaire Administration in people with Depression and Tobacco Use Disorder, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KickAsh group compliance with mood rating (time frame: Up to 8 weeks from start of study). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.