SmokingNCT02069483
Testing Methods of Self-persuasion Involving Cigarette Smoking
A study testing Motivational Interviewing and Tailored Feedback in people with Smoking, run by Duke University at 1 site in United States.
Trial summary
Smokers who are not actively engaged in quitting will participate in a study using self-generated text and audio text messages containing reasons to quit smoking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- Motivational Interviewing and Tailored Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Sep 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older
- not actively engaged in trying to quit smoking
- must have smoked 100 cigarettes to date
- must smoke at least 1 cigarette per day
- must own smartphone capable of receiving messages from study email
- must agree to receive text messages between 8-9am each weekday for 2 weeks
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Smokers who are not actively engaged in quitting will participate in a study using self-generated text and audio text messages containing reasons to quit smoking.
Read the detailed description
Participants must have a smartphone that can accept text messages from an email address and link to a study related website to hear audio recordings, and be willing to receive a text message each weekday for two weeks between 8-9am as part of the study. After completing a phone screener, participants will complete a baseline phone survey. Within two weeks of the baseline survey, participants will come to an in-person session. At that time they will be randomized with equal probability to one of two conditions: 1) Motivational Interviewing (MI), or 2) tailored feedback on reasons for quitting. After undergoing MI or receiving tailored feedback, participants will be asked to generate message that they feel would motivate them to quit. These messages will be both text and audio. After generating and reviewing these messages, participants will then evaluate these messages before ending the laboratory session. Starting two days after their laboratory session, between 8:00am and 9:00am, staff will send participants one of the self-generated text messages with a link to also hear the message; this process will last for two weeks. Within a week of stopping sending messages, participants will be asked to complete a final phone survey to elicit smoking behaviors and provided feedback on the messaging.
- Conditions
- Smoking
- Being tested
- Motivational Interviewing, Tailored Feedback
- Keywords
- smoking, smoker, text, smartphone, motivation, quitting, cessation, feedback, messages
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Subjects will engage in motivational interviewing in order to generate motivating messages related to quitting smoking.
Tailored FeedbackBehavioural
Subjects will self-generate reasons they want to quit smoking during the baseline survey and record these reasons during the in-person activity.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Active comparator | Subjects will engage in motivational interviewing and come up with messages to motivate quitting during the activity. Receives: Behavioral: Motivational Interviewing |
| Tailored Feedback | Active comparator | Subjects will use reasons for quitting that they provided during the phone baseline for the text messages and audio recordings. Receives: Behavioral: Tailored Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of messages generated during in-person visit
Measured: one hour
Secondary outcomes (1)
Quality of messages
Smokers' evaluation of message (e.g., persuasiveness, accuracy/credibility, ease of generating messages).
Measured: before and after completion of the trial, approximately 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionSep 2014
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 Duke UniversityThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isaac Lipkus, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069483
- Sponsor's protocol ID
- Pro00048251
- Status last verified
- Sep 2014
- First submitted
- 19 Feb 2014
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Methods of Self-persuasion Involving Cigarette Smoking
- ClinicalTrials.gov ID
- NCT02069483
- Acronym / sponsor ID
- Pro00048251
- Conditions
- Smoking
- Keywords
- smoking, smoker, text, smartphone, motivation, quitting, cessation, feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Feb 2014 (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.
Smokers who are not actively engaged in quitting will participate in a study using self-generated text and audio text messages containing reasons to quit smoking.
Detailed description
Participants must have a smartphone that can accept text messages from an email address and link to a study related website to hear audio recordings, and be willing to receive a text message each weekday for two weeks between 8-9am as part of the study. After completing a phone screener, participants will complete a baseline phone survey. Within two weeks of the baseline survey, participants will come to an in-person session. At that time they will be randomized with equal probability to one of two conditions: 1) Motivational Interviewing (MI), or 2) tailored feedback on reasons for quitting. After undergoing MI or receiving tailored feedback, participants will be asked to generate message that they feel would motivate them to quit. These messages will be both text and audio. After generating and reviewing these messages, participants will then evaluate these messages before ending the laboratory session. Starting two days after their laboratory session, between 8:00am and 9:00am, staff will send participants one of the self-generated text messages with a link to also hear the message; this process will last for two weeks. Within a week of stopping sending messages, participants will be asked to complete a final phone survey to elicit smoking behaviors and provided feedback on the messaging.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Active comparator | Behavioral: Motivational InterviewingSubjects will engage in motivational interviewing and come up with messages to motivate quitting during the activity. |
| Tailored Feedback | Active comparator | Behavioral: Tailored FeedbackSubjects will use reasons for quitting that they provided during the phone baseline for the text messages and audio recordings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years old or older
- not actively engaged in trying to quit smoking
- must have smoked 100 cigarettes to date
- must smoke at least 1 cigarette per day
- must own smartphone capable of receiving messages from study email
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Motivational InterviewingSubjects will engage in motivational interviewing in order to generate motivating messages related to quitting smoking. | Behavioural | Motivational Interviewing |
| Tailored FeedbackSubjects will self-generate reasons they want to quit smoking during the baseline survey and record these reasons during the in-person activity. | Behavioural | Tailored Feedback |
Primary outcome
Number of messages generated during in-person visit
Time frame: one hour
1 secondary outcome
Quality of messages
Time frame: before and after completion of the trial, approximately 3 weeks
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 26 Sep 2014.
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
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.
Isaac Lipkus, PhD principal investigator
Duke University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Tailored Feedback in people with Smoking, run by Duke University 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 6 inclusion and 0 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 26 Sep 2014. 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?
Number of messages generated during in-person visit (time frame: one hour). 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 26 Sep 2014.