- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07460453
Racial Disparities in the Expression of Paranoia
Study of Life Challenges, Personality, and Emotional Experiences
Paranoia is a pattern of thinking in which people feel suspicious or believe others may want to harm them. It can occur in many people, not only those with a mental health diagnosis, and it can affect daily life, relationships, and overall well-being. Research has consistently shown that Black Americans report higher levels of paranoia than White Americans, even when they do not have a clinical diagnosis. However, the reasons for this difference are not well understood.
The goal of this study is to better understand why these differences exist. In the experimental part of the study, researchers will use a randomized design to test whether exposure to stressful experiences related to race leads to higher levels of paranoia among Black American participants. The study will also examine factors that may strengthen or weaken this effect, such as individual experiences and personal characteristics.
By identifying how stressful experiences related to race influence paranoia, this research aims to improve how paranoia is measured and understood across different groups. These findings may help researchers and clinicians use more accurate and culturally appropriate tools to assess psychosis-related experiences in diverse populations.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Paranoia, a core symptom of psychosis, is characterized by beliefs of being threatened, persecuted, or conspiratorially targeted. In contemporary psychological approaches, paranoia is defined as a dimensional and transdiagnostic construct existing on a continuum of severity throughout the population and conferring risk for negative outcomes including impairments in social functioning, well-being, and quality of life.
Despite its centrality in understanding the psychosis spectrum, including clinical conditions such as schizophrenia, paranoia is a construct vulnerable to various individual- and group-level influences. Social threats experienced by some groups may rightfully compel increased mistrust and suspiciousness of others. In fact, numerous cross-sectional investigations demonstrate that Black Americans consistently endorse higher levels of paranoia compared to their White counterparts, independent of clinical status. Furthermore, emerging evidence indicates a positive association between adverse experiences related to race and increased paranoia endorsements among Black Americans.
This project addresses the insufficient understanding of factors contributing to group differences in paranoia between Black and White Americans. Moreover, existing evidence linking adverse experiences related to race and heightened paranoia among Black Americans is correlational; possible causal pathways have not been examined through experimental means. This knowledge gap is significant because Black Americans endorse heightened traits and experiences associated with psychosis across the severity spectrum, ultimately leading to a three- to fourfold higher diagnostic rate of psychotic disorders compared to their White counterparts. Importantly, current assessment tools may systematically mischaracterize psychosis risk among Black Americans across this severity spectrum in both research and clinical practice, as they were not designed to account for the potential confounding impact of adverse experiences related to race on item endorsements among diverse respondents. Errors in measurement-which may stem from poor cultural sensitivity and be sustained by a paucity of knowledge of how social threats may impact the phenotypic expression of psychosis-have been implicated as one potential cause of the overrepresentation of Black Americans within psychotic disorder diagnoses. This theory is compatible with other potential mechanisms, including inequities in social determinants of health driving true increases in psychotic disorders among Black Americans. Consequently, there is a high likelihood that assessment tools systematically conflate culturally justified mistrust with psychopathological symptomology across this severity spectrum, making accurate assessment of paranoia among diverse respondents a pressing clinical concern. Accordingly, this project focuses on self-reported paranoia among Black and White adults in the general population.
The primary objective of this study is to experimentally test whether exposure to race-related adverse experiences results in acute increases in self-reported paranoia. Our first goal is to experimentally test the causal impact of adverse experiences related to race on paranoia among Black Americans by examining the extent to which paranoia can be increased following priming exposure to blatant and subtle adverse experiences related to race using a guided visual imagery paradigm. Study participants, comprising 480 Black American adults recruited from the community, will engage in a guided visual imagery task that involves actively envisioning scenarios presented via audiotape-an established method for priming race-related stressors in controlled experimental settings. Participants will be randomly assigned to one of three conditions: blatant adverse experience, subtle adverse experience, social exclusion, or neutral control. Primary outcomes include changes in self-reported paranoia following experimental exposure. It is hypothesized that priming adverse experiences related to race will drive significant increases in self-reported paranoia compared to the neutral control condition.
A secondary objective of this study is to identify individual-level risk and resilience factors that influence variability in experimentally induced changes in paranoia. A subsequent goal will identify risk and resilience factors that may influence the magnitude of the experimental effects observed in Goal 1. Using data collected within the same experimental framework, it is hypothesized that self-reported adverse experiences related to race, in addition to race and ethnicity, will moderate paranoia endorsements observed among Black Americans following experimental exposure to race-related adverse experiences.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: J Wolny
- Phone Number: 812-855-2620
- Email: wolny@iu.edu
Study Contact Backup
- Name: William Hetrick
- Phone Number: 812-855-2620
- Email: whetrick@iu.edu
Study Locations
-
-
Indiana
-
Bloomington, Indiana, United States, 47405
- Recruiting
- Department of Psychological and Brain Sciences
-
Contact:
- J Wolny
- Phone Number: 8128552620
- Email: wolny@iu.edu
-
Principal Investigator:
- J Wolny
-
Contact:
- William P Hetrick
- Phone Number: 8128552620
- Email: whetrick@iu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- 18 years of age or older
- Self-identify as non-Hispanic Black or African American
- Currently reside in the United States
- Speak and read English
- Registered as a survey participant on the Prolific platform
Exclusion Criteria
- Younger than 18 years of age
- Do not self-identify as non-Hispanic Black or African American
- Do not currently reside in the United States
- Do not speak or read English
- Not registered as a survey participant on the Prolific platform
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Blatant Race-Related Adverse Experience Imagery
Participants are exposed to an audio-guided imagery scenario depicting a blatant race-related adverse experience.
The guided imagery task instructs participants to vividly imagine a situation involving explicit racial hostility or discrimination.
This intervention is designed to experimentally prime exposure to overt race-related social threat in a controlled setting.
|
Participants complete an online, audio-guided visual imagery task designed to experimentally prime social experiences under standardized conditions.
After brief instructions to imagine themselves actively participating in each scene, participants complete practice trials with neutral content and then are randomized to listen to one audio-recorded scenario matched to their assigned condition.
Each trial includes a brief relaxation period, an instruction period, a guided imagery listening period, and a short recovery period.
Scenarios are approximately 30 seconds and are delivered via headphones/speakers within the survey platform.
Following the imagery task, participants complete post-task self-report assessments capturing current (state) experiences, including state paranoia and manipulation checks (e.g., imagery vividness and task engagement).
The task is administered once in a single session.
|
|
Experimental: Subtle Race-Related Adverse Experience Imagery
Participants are exposed to an audio-guided imagery scenario depicting a subtle race-related adverse experience, such as ambiguous or indirect racial bias.
The guided imagery task instructs participants to imagine a situation involving covert or nuanced race-related social threat, consistent with commonly reported microaggressive experiences.
|
Participants complete an online, audio-guided visual imagery task designed to experimentally prime social experiences under standardized conditions.
After brief instructions to imagine themselves actively participating in each scene, participants complete practice trials with neutral content and then are randomized to listen to one audio-recorded scenario matched to their assigned condition.
Each trial includes a brief relaxation period, an instruction period, a guided imagery listening period, and a short recovery period.
Scenarios are approximately 30 seconds and are delivered via headphones/speakers within the survey platform.
Following the imagery task, participants complete post-task self-report assessments capturing current (state) experiences, including state paranoia and manipulation checks (e.g., imagery vividness and task engagement).
The task is administered once in a single session.
|
|
Placebo Comparator: Neutral Control Imagery
Participants are exposed to an audio-guided imagery scenario depicting a neutral, non-threatening experience unrelated to race or social evaluation.
This condition serves as a control for engagement with the guided imagery task without exposure to race-related adverse content.
|
Participants complete an online, audio-guided visual imagery task designed to experimentally prime social experiences under standardized conditions.
After brief instructions to imagine themselves actively participating in each scene, participants complete practice trials with neutral content and then are randomized to listen to one audio-recorded scenario matched to their assigned condition.
Each trial includes a brief relaxation period, an instruction period, a guided imagery listening period, and a short recovery period.
Scenarios are approximately 30 seconds and are delivered via headphones/speakers within the survey platform.
Following the imagery task, participants complete post-task self-report assessments capturing current (state) experiences, including state paranoia and manipulation checks (e.g., imagery vividness and task engagement).
The task is administered once in a single session.
|
|
Experimental: Social Exclusion Imagery
Participants listen to an audio-guided imagery scenario depicting social exclusion (e.g., being left out or rejected in a social context) without reference to race and are instructed to vividly imagine the situation.
This condition isolates the effect of social threat/exclusion from race-specific content.
|
Participants complete an online, audio-guided visual imagery task designed to experimentally prime social experiences under standardized conditions.
After brief instructions to imagine themselves actively participating in each scene, participants complete practice trials with neutral content and then are randomized to listen to one audio-recorded scenario matched to their assigned condition.
Each trial includes a brief relaxation period, an instruction period, a guided imagery listening period, and a short recovery period.
Scenarios are approximately 30 seconds and are delivered via headphones/speakers within the survey platform.
Following the imagery task, participants complete post-task self-report assessments capturing current (state) experiences, including state paranoia and manipulation checks (e.g., imagery vividness and task engagement).
The task is administered once in a single session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Paranoia
Time Frame: Immediately post-intervention (single session)
|
Self-reported paranoia will be assessed immediately following the experimental task to capture acute, experimentally induced changes in paranoia.
State paranoia will be measured using the Revised Green Paranoid Thought Scale (R-GPTS; Green et al., 2019), an 18-item validated Likert-type measure appropriate for clinical and nonclinical samples.
Scores range from 0-72, with higher scores indicating greater state paranoia.
The R-GPTS includes two subscales: (1) Ideas of Reference and (2) Ideas of Persecution.
Items are summed to generate subscale and total scores.
The scale demonstrates excellent internal consistency (α > .90),
and prior work (Wolny et al., revisions submitted) established measurement invariance across Black and White American participants.
|
Immediately post-intervention (single session)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Affective Response
Time Frame: Pre-intervention and immediately post-intervention
|
Self-reported affective responses will be assessed before and after the experimental task to characterize changes in emotional valence and arousal following exposure to the guided imagery scenarios.
Affect will be measured using two Self-Assessment Manikin (SAM; Bradley & Lang, 1994) single-item ratings: (1) Valence, ranging from 1 (Unpleasant) to 9 (Very pleasant), with higher scores indicating more pleasant affect; and (2) Arousal, ranging from 1 (Calm) to 9 (Aroused), with higher scores indicating greater emotional activation.
|
Pre-intervention and immediately post-intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Imagery Vividness and Task Engagement
Time Frame: Immediately post-intervention
|
Self-reported ratings of imagery vividness, task engagement, and perceived realism will be obtained immediately post-task to evaluate the quality and consistency of engagement with the guided imagery scenarios. Accordingly, participants will complete a structured Participation and Reflection Engagement Check. After listening to the assigned scene, participants will briefly describe the scenario as they experienced it (1-2 sentences or short phrases) across four domains: (1) Context (where and when the event took place and who was involved), (2) Experience (what occurred and the actions of those involved), (3) Feelings (emotional responses at the time and currently), and (4) Aftermath (immediate consequences and any changes in behavior or outlook). These responses will be used to verify attention, engagement, and comprehension of the guided imagery task. |
Immediately post-intervention
|
|
Perceived Stress During Task
Time Frame: Immediately post-intervention
|
Self-reported ratings of stress and emotional intensity experienced during the guided imagery task, collected immediately following task completion. Perceived Stress
Perceived Controllability
Emotional Intensity
|
Immediately post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25650
- F31MH135692 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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