SmokingNCT01812070
Innovative Smartphone Application of a New Behavioral Method to Quit Smoking: Pilot Trial (Smart Quit)
A study testing ACT and CBT in people with Smoking, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This innovative study will compare a newly developed smartphone application for Acceptance and Commitment Therapy (ACT) to a smartphone application for traditional cognitive behavioral therapy (CBT). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- ACT and CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 or older
- smokes at least five cigarettes daily for at least past 12 months
- wants to quit in the next 30 days
- interested in learning skills to quit smoking
- willing to be randomly assigned to either smartphone application
- resides in US
Show all 13Show fewer
- has at least daily access to their own personal Apple iPhone 4, 4s, or 5
- knows how to login and download a smartphone application from Apple's "App Store" Store
- willing and able to read in English
- not participating in other smoking cessation interventions (including our other intervention studies)
- has never used the NCI's Quit Guide smartphone application.]
- willing to complete one follow-up survey
- provide email, phone, and mailing address.
Who cannot join
- The exclusion criteria are the opposite of the inclusion criteria above.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: Innovative Smartphone Application of a New Behavioral Method to Quit Smoking: Pilot Randomized Trial
This innovative study will compare a newly developed smartphone application for Acceptance and Commitment Therapy (ACT) to a smartphone application for traditional cognitive behavioral therapy (CBT).
Read the detailed description
The study matches these National Cancer Institute (NCI) research funding priorities: (1) increasing the dissemination of smoking cessation treatments and (2) new treatment approaches to boost the effectiveness of cessation interventions.
- Conditions
- Smoking
- Being tested
- ACT, CBT
- Keywords
- smoking cessation, quit smoking
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTBehavioural
Also called Acceptance & Commitment Therapy
CBTBehavioural
Also called Cognitive Behavioral Therapy (CBT)
| Study group | Role | What they receive |
|---|---|---|
| ACT | Experimental | Acceptance \& Commitment Therapy Receives: Behavioral: ACT |
| CBT | Active comparator | Cognitive Behavioral Therapy Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day and 24-hour point prevalence quit rates
Measured: 2 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812070
- Sponsor's protocol ID
- 7957
- Status last verified
- Mar 2015
- First submitted
- 13 Mar 2013
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Smartphone Application of a New Behavioral Method to Quit Smoking: Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT01812070
- Acronym / sponsor ID
- 7957
- Conditions
- Smoking
- Keywords
- smoking cessation, quit smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 15 Mar 2013 (estimated)
- 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 innovative study will compare a newly developed smartphone application for Acceptance and Commitment Therapy (ACT) to a smartphone application for traditional cognitive behavioral therapy (CBT).
Detailed description
The study matches these National Cancer Institute (NCI) research funding priorities: (1) increasing the dissemination of smoking cessation treatments and (2) new treatment approaches to boost the effectiveness of cessation interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT | Experimental | Behavioral: ACTAcceptance \& Commitment Therapy |
| CBT | Active comparator | Behavioral: CBTCognitive Behavioral Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- age 18 or older
- smokes at least five cigarettes daily for at least past 12 months
- wants to quit in the next 30 days
- interested in learning skills to quit smoking
- willing to be randomly assigned to either smartphone application
Key exclusion criteria (1 listed)
- The exclusion criteria are the opposite of the inclusion criteria above.
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 |
|---|---|---|
| ACTAlso: Acceptance & Commitment Therapy | Behavioural | ACT |
| CBTAlso: Cognitive Behavioral Therapy (CBT) | Behavioural | CBT |
Primary outcome
7-day and 24-hour point prevalence quit rates
Time frame: 2 months post randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT and CBT in people with Smoking, run by Fred Hutchinson 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 13 inclusion and 1 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: finished, as of the sponsor's last update on 6 Mar 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
7-day and 24-hour point prevalence quit rates (time frame: 2 months post randomization). 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 Mar 2015.