- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02069483
Testing Methods of Self-persuasion Involving Cigarette Smoking
September 25, 2014 updated by: Duke University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Motivational Interviewing
Subjects will engage in motivational interviewing and come up with messages to motivate quitting during the activity.
|
Subjects will engage in motivational interviewing in order to generate motivating messages related to quitting smoking.
|
|
Active Comparator: Tailored Feedback
Subjects will use reasons for quitting that they provided during the phone baseline for the text messages and audio recordings.
|
Subjects will self-generate reasons they want to quit smoking during the baseline survey and record these reasons during the in-person activity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of messages generated during in-person visit
Time Frame: one hour
|
one hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of messages
Time Frame: before and after completion of the trial, approximately 3 weeks
|
Smokers' evaluation of message (e.g., persuasiveness, accuracy/credibility, ease of generating messages).
|
before and after completion of the trial, approximately 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
February 19, 2014
First Submitted That Met QC Criteria
February 20, 2014
First Posted (Estimate)
February 24, 2014
Study Record Updates
Last Update Posted (Estimate)
September 26, 2014
Last Update Submitted That Met QC Criteria
September 25, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- Pro00048251
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.