NCT06462950

Brief 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. 1.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)?
  2. 2.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)?

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started May 2028

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
3.9 years until next milestone

Study Start

First participant enrolled

May 1, 2028

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 17, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 4, 2024

Last Update Submit

June 11, 2024

Conditions

Keywords

stigmatization

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 min

Study Arms (2)

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).

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.

Behavioral: Do men and women differ in their reactions to the experimental conditions.

Interventions

Do men and women differ in their reactions to the experimental conditions.

ConcealmentOstracism

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identit
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • daily smoker who smoker more than 5 cigarettes daily and have smoked for at least 1 year
  • speak English reside in the United States

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OstracismStereotyping

Condition Hierarchy (Ancestors)

Social IsolationSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 4, 2024

First Posted

June 17, 2024

Study Start (Estimated)

May 1, 2028

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

June 17, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share
Shared Documents
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