- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06462950
Experiment Among Smokers in Which Two Variables Are Manipulated: Ostracism and Concealability
June 11, 2024 updated by: Marie Helweg-Larsen, Dickinson College
Study 3: The Experimental Examination of Ostracism and Concealability on Gendered Stigma Smoking Outcomes
The goal of this experimental study is to learn about the effects of ostracism and concealment among adult smokers. The main aims are:
- Determine the causal consequences of gendered stigmatization. Specifically, do women react more strongly than men to exclusion (as opposed to inclusion) especially when their gender is revealed (as opposed to concealed) for outcomes such as smoking stigma, stress, cognitive depletion, smoking attitudes, and smoking cessation intentions (Study 3)?
- Examine the moderating roles of cultural context. Specifically, contrasting the cultural context in the US and Denmark (where gender norms are more egalitarian) do Danish smokers show fewer gender differences than US smokers in how they describe and react to their smoking stigmatization experiences (Study 1, 2, and 3)?
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The proposed studies examine cross-culturally the reasons why among smokers, women feel more stigmatized than men do.
An experiment with US and Danish smokers will examine how men and women differ in their reactions to being stigmatized (using a standard exclusion manipulation) when their gender is revealed instead of concealed.
The outcome measures will include stress, smoking stigma, cognitive depletion, smoking attitudes, and smoking cessation intentions.
Study Type
Interventional
Enrollment (Estimated)
340
Phase
- Not Applicable
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- daily smoker who smoker more than 5 cigarettes daily and have smoked for at least 1 year
- speak English reside in the United States
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: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ostracism
Ostracism is manipulated by randomly assigning people to the inclusion condition (they play an online ball tossing game and get the ball passed a third of the time) or exclusion condition (they get the ball passed twice in the beginning of the game and then not again).
|
Do men and women differ in their reactions to the experimental conditions.
|
|
Experimental: Concealment
Concealment is manipulated by randomly assigning the participants to information that the other players did (revealed condition) or did not know (concealed condition) the gender of the participant.
|
Do men and women differ in their reactions to the experimental conditions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive depletion
Time Frame: 10 min
|
The Stroop Color-Word Interference Test measures the executive control needed to suppress reading a word and instead naming the color of the word.
The test will be adminstered once immediately after the experimental task.
|
10 min
|
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 (Estimated)
May 1, 2028
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
December 1, 2028
Study Registration Dates
First Submitted
June 4, 2024
First Submitted That Met QC Criteria
June 11, 2024
First Posted (Actual)
June 17, 2024
Study Record Updates
Last Update Posted (Actual)
June 17, 2024
Last Update Submitted That Met QC Criteria
June 11, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MHLStudy3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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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