OstracismNCT06462950
Experiment Among Smokers in Which Two Variables Are Manipulated: Ostracism and Concealability
A study testing Do men and women differ in their reactions to the experimental conditions. in people with Ostracism, run by Dickinson College.
Trial summary
The goal of this experimental study is to learn about the effects of ostracism and concealment among adult smokers. The main aims are: 1. Determine the causal consequences of gendered stigmatization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ostracism
- What is being tested?
- Do men and women differ in their reactions to the experimental conditions.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- May 2028to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- daily smoker who smoker more than 5 cigarettes daily and have smoked for at least 1 year
- speak English reside in the United States
Who cannot join
None listed.
About this study
Official title: 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)?
Read the 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.
- Conditions
- Ostracism
- Being tested
- Do men and women differ in their reactions to the experimental conditions.
- Keywords
- stigmatization
- Medical subject headings
- Ostracism, Stereotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Do men and women differ in their reactions to the experimental conditions.Behavioural
Do men and women differ in their reactions to the experimental conditions.
| Study group | Role | What they receive |
|---|---|---|
| Ostracism | Experimental | 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). Receives: Behavioral: Do men and women differ in their reactions to the experimental conditions. |
| Concealment | Experimental | 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. Receives: Behavioral: Do men and women differ in their reactions to the experimental conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive depletion
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.
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study startMay 2028 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OstracismStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dickinson College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Helweg-Larsen, Dickinson College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462950
- Sponsor's protocol ID
- MHLStudy3
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study 3: The Experimental Examination of Ostracism and Concealability on Gendered Stigma Smoking Outcomes
- ClinicalTrials.gov ID
- NCT06462950
- Acronym / sponsor ID
- MHLStudy3
- Conditions
- Ostracism
- Keywords
- stigmatization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Dickinson CollegeUniversity, hospital or other
- Study start
- May 2028 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Jun 2024 (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.
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)?
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ostracism | Experimental | Behavioral: Do men and women differ in their reactions to the experimental conditions.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). |
| Concealment | Experimental | Behavioral: Do men and women differ in their reactions to the experimental conditions.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- daily smoker who smoker more than 5 cigarettes daily and have smoked for at least 1 year
- speak English reside in the United States
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 |
|---|---|---|
| Do men and women differ in their reactions to the experimental conditions.Do men and women differ in their reactions to the experimental conditions. | Behavioural | Concealment, Ostracism |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Do men and women differ in their reactions to the experimental conditions. in people with Ostracism, run by Dickinson College.
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 2 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: opening soon, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Cognitive depletion (time frame: 10 min). 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 17 Jun 2024.