Smoking CessationNCT04383782
Examining Outcome Expectancies and Behavioral Reinforcers Among Young Adult Smokers
A study testing Expectancy Challenge and Expectancy Challenge + Behavioral Activation in people with Smoking Cessation, run by American University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Expectancy Challenge and Expectancy Challenge + Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2020to 4 Jan 2021
- 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 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
American University
Washington D.C., District of Columbia, 20016
About this study
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.
- Conditions
- Smoking Cessation
- Being tested
- Expectancy Challenge, Expectancy Challenge + Behavioral Activation, Control
- Keywords
- smoking cessation, motivation, outcome expectancies, behavioral reinforcers
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expectancy ChallengeBehavioural
Expectancy challenge intervention (see description in study arms).
Expectancy Challenge + Behavioral ActivationBehavioural
Expectancy challenge + behavioral activation interventions (see description in study arms)
ControlBehavioural
Neutral reading condition (see description in study arms).
| Study group | Role | What they receive |
|---|---|---|
| Expectancy Challenge | Active comparator | 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. Receives: Behavioral: Expectancy Challenge |
| Expectancy Challenge + Behavioral Activation | Experimental | 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. Receives: Behavioral: Expectancy Challenge + Behavioral Activation |
| Neutral Reading | Placebo comparator | 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quit attempt
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.
Measured: 4-week follow up
Motivation to quit
Contemplation ladder score (range 0-10; higher scores indicate more motivation to quit)
Measured: 4-week follow up
Secondary outcomes (3)
Smoking rate
past month average self-reported smoking rate
Measured: 4-week follow up
Outcome expectancies
Smoking Consequences Questionnaire (S-SCQ); expected positive and negative consequences of cigarette smoking (range 0-9; higher scores indicate greater positive or negative expectancies)
Measured: 4-week follow up
Behavioral reinforcers
Pleasant Events Schedule (PES); reported behaviors that are pleasurable and not associated with smoking/urge to smoke
Measured: 4-week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start22 May 2020
- Primary completion7 Dec 2020
- Study completion4 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Kaufmann, American University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383782
- Sponsor's protocol ID
- KDYAS2020
- Status last verified
- Jan 2021
- First submitted
- 7 May 2020
- Last updated
- 20 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Outcome Expectancies and Behavioral Reinforcers Among Young Adult Smokers
- ClinicalTrials.gov ID
- NCT04383782
- Acronym / sponsor ID
- KDYAS2020
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, motivation, outcome expectancies, behavioral reinforcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- American UniversityUniversity, hospital or other
- Study start
- 22 May 2020 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 4 Jan 2021 (actual)
- First posted
- 12 May 2020 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Expectancy Challenge | Active comparator | Behavioral: Expectancy ChallengeThe 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 + Behavioral Activation | Experimental | Behavioral: Expectancy Challenge + Behavioral ActivationIn 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. |
| Neutral Reading | Placebo comparator | Behavioral: ControlThe 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Expectancy ChallengeExpectancy challenge intervention (see description in study arms). | Behavioural | Expectancy Challenge |
| Expectancy Challenge + Behavioral ActivationExpectancy challenge + behavioral activation interventions (see description in study arms) | Behavioural | Expectancy Challenge + Behavioral Activation |
| ControlNeutral reading condition (see description in study arms). | Behavioural | Neutral Reading |
Primary outcome
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.
Motivation to quit
Time frame: 4-week follow up
Contemplation ladder score (range 0-10; higher scores indicate more motivation to quit)
3 secondary outcomes
Smoking rate
Time frame: 4-week follow up
Outcome expectancies
Time frame: 4-week follow up
Behavioral reinforcers
Time frame: 4-week follow up
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 20 Jan 2021.
Related trials for Smoking Cessation
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
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
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.
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 Expectancy Challenge and Expectancy Challenge + Behavioral Activation in people with Smoking Cessation, run by American 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 5 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 20 Jan 2021. 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. Some participants in this study may receive a placebo. 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?
Quit attempt (time frame: 4-week follow up). The study lists 2 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 20 Jan 2021.