- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04383782
Examining Outcome Expectancies and Behavioral Reinforcers Among Young Adult Smokers
January 18, 2021 updated by: Amanda Kaufmann, American University
Chronic cigarette smoking habits often begin in adolescence or early adulthood.
98% of cigarette smokers try their first cigarette before the age of 26.
Thus, young adult smokers represent an important target for early smoking cessation intervention.
This study tests two interventions designed to increase motivation to quit and decrease smoking behavior.
These interventions include: an expectancy challenge approach, which aims to increase negative beliefs about the consequences of smoking; and a behavioral economics approach, which encourages participants to substitute non-smoking behaviors that may still provide reinforcement similar to reinforcement derived from smoking a cigarette.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
159
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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District of Columbia
-
Washington, District of Columbia, United States, 20016
- American University
-
-
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 to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-35 years old
- English fluency
- Living in the United States
- Smoked at least 1 cigarette per week during the past month
- Willing to be contacted for 1-month follow up assessment
Exclusion Criteria:
- N/A
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Expectancy Challenge
The expectancy challenge intervention will involve two brief videotaped testimonials in which former smokers discuss their experiences with smoking-related health conditions.
Participants will be encouraged to reflect back on the content of each video once per week leading up to the follow-up assessment.
|
Expectancy challenge intervention (see description in study arms).
|
Experimental: Expectancy Challenge + Behavioral Activation
In addition to the expectancy challenge intervention (see Expectancy Challenge condition), participants in the Expectancy Challenge + Behavioral Activation group will also receive a novel behavioral activation intervention.
Participants will be presented with brief psychoeducation about behavioral activation, several examples of possible functions of cigarette smoking, and several suggestions of behavioral strategies.
All participants will receive the same information, but they will be encouraged to apply the information to their personal circumstances and to consider additional examples of rewarding activities they may engage in over the next four weeks.
Participants will also be encouraged to engage in at least one behavioral activation activity each week leading up to the follow-up assessment.
|
Expectancy challenge + behavioral activation interventions (see description in study arms)
|
Placebo Comparator: Neutral Reading
The control group will receive neutral reading materials related to the components and structure of a cigarette.
The content will be strictly curated so as to avoid inadvertently encouraging or discouraging smoking among participants.
|
Neutral reading condition (see description in study arms).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quit attempt
Time Frame: 4-week follow up
|
yes/no, whether or not the participant made a 24-hour (or longer) quit attempt between the date of the main experiment and the date of the 4-week follow-up assessment.
|
4-week follow up
|
Motivation to quit
Time Frame: 4-week follow up
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Contemplation ladder score (range 0-10; higher scores indicate more motivation to quit)
|
4-week follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking rate
Time Frame: 4-week follow up
|
past month average self-reported smoking rate
|
4-week follow up
|
Outcome expectancies
Time Frame: 4-week follow up
|
Smoking Consequences Questionnaire (S-SCQ); expected positive and negative consequences of cigarette smoking (range 0-9; higher scores indicate greater positive or negative expectancies)
|
4-week follow up
|
Behavioral reinforcers
Time Frame: 4-week follow up
|
Pleasant Events Schedule (PES); reported behaviors that are pleasurable and not associated with smoking/urge to smoke
|
4-week follow up
|
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 (Actual)
May 22, 2020
Primary Completion (Actual)
December 7, 2020
Study Completion (Actual)
January 4, 2021
Study Registration Dates
First Submitted
May 7, 2020
First Submitted That Met QC Criteria
May 11, 2020
First Posted (Actual)
May 12, 2020
Study Record Updates
Last Update Posted (Actual)
January 20, 2021
Last Update Submitted That Met QC Criteria
January 18, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- KDYAS2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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