- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05325320
Intervention to Reduce Serious Mental Illness and Suicide Stigma Among Medical Students
Reducing Serious Mental Illness and Suicide Stigma Among Medical Students
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
People with serious mental illness (PSMI; i.e. Schizophrenia and bipolar disorder) die, on average, 25 years earlier than the general population. Suicide is a key factor for this disparity as it is the leading cause of unnatural deaths among this population. Research identifies Latinos as a particularly vulnerable group, accounting for one of the highest rates (over 30%) of serious mental illness (SMI) among ethnic minorities in the United States (US). Latinos also hold one of the highest prevalence of suicide ideation and attempts (SIA) with rates of 10.1% and 4.4% respectively. This scenario worsens for one Latino subgroup, Puerto Ricans, who have the highest prevalence of SMI (36%) and SIA among Latinos in the US (7.9% and 3.5% respectively). Taken together, these facts present a concerning scenario for Latinos, especially Puerto Ricans with SMI/SIA. Health professionals play a key role in identifying SMI/SIA among patients; unfortunately, SMI/SIA stigma hinders this process.
The proposed study aims to: 1) develop the content of an intervention to reduce SMI/SIA stigma among medical students, 2) determine the acceptability and feasibility of implementing the intervention among medical students by examining recruitment/screening procedures, participation/refusal/retention rates, and participant satisfaction, and; 3) pilot test the preliminary efficacy of the intervention in reducing SMI/SIA stigma among medical students by increasing knowledge of SMI and SIA, reducing negative attitudes towards SMI/SIA and increasing behavioral skills for providing healthcare to PSMI.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eliut Rivera-Segarra, Ph.D
- Phone Number: 787-840-2575
- Email: elrivera@psm.edu
Study Locations
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-
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Ponce, Puerto Rico
- Recruiting
- Ponce Health Sciences University
-
Contact:
- Eliut Rivera Segarra, Ph.D
- Phone Number: 787-840-2575
-
-
-
-
Florida
-
Miami, Florida, United States, 33199
- Not yet recruiting
- Florida International University
-
Contact:
- Nelson Varas Díaz, Ph.D
- Phone Number: 305-348-2618
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Medical student currently in third year of medical school training
Exclusion Criteria:
- Do not speak English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stigma Reduction Intervention
Participants randomized to the experimental condition will receive the SMI/SIA Stigma Reduction Intervention.
|
Online course designed to reduce stigma behaviors towards serious mental illness and suicide ideation and attempt among medical students.
It aims to improve medical students' healthcare delivery skills.
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Other: Disaster Preparedness Course
Participants randomized to the control condition will receive a Disaster Preparedness Course, addressing the basics of natural disaster preparedness.
|
Online course designed to improve professionals' skills and competencies for engaging in disaster preparedness.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increase from baseline in scores on the Behavioral Health Skills Inventory (BHSI)
Time Frame: Baseline, immediately after intervention, 2 week follow-up
|
This 29-item inventory assesses standardized patient simulation interactions including three behavioral components addressing general healthcare related behaviors, SMI related behaviors and SIA related behaviors.
Scores range from 0 to 58, with higher numbers reflecting higher skills in healthcare service delivery for PSMI/SIA.
|
Baseline, immediately after intervention, 2 week follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increase from baseline in scores on the Serious Mental Illness Literacy Scale
Time Frame: Baseline, immediately after intervention, 2 week follow-up
|
This adapted and pilot tested version of the Mental Health Literacy Scale, measures participants' knowledge regarding SMI.
The Scale addresses the ability to recognize SMI including: Bipolar Disorder and Schizophrenia.
The Scale is composed of two sections measuring SMI knowledge.
The first is composed of 15 items (4-point Likert Scale) ranging from (1) very unlikely to (4) very likely.
The second section is composed of 20 items using a 5-point Likert Scale ranging from (1) strongly disagree to (5) strongly agree.
|
Baseline, immediately after intervention, 2 week follow-up
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Increase from baseline in scores on the Literacy of Suicide Scale (LOSS)
Time Frame: Baseline, immediately after intervention, 2 week follow-up
|
This SIA knowledge measure is answered in a correct/incorrect/don't know format.
The 27 items are rated on a 3-point scale (true, false, or I don't know), with correct responses allocated a score of 1 and incorrect or I don't know responses assigned a score of 0. Higher LOSS scores indicate higher suicide literacy.
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Baseline, immediately after intervention, 2 week follow-up
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Decrease from baseline in scores on The Mental Health Stigma Scale for Health Professionals
Time Frame: Baseline, immediately after intervention, 2 week follow-up
|
Used to evaluate mental illness stigma among health professionals, including medical students.
This 12-item measure uses a 5-point Likert from (1) strongly agree to (5) strongly disagree.
It has three dimensions (social distance, negative character attributions, and self-sufficiency problems).
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Baseline, immediately after intervention, 2 week follow-up
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Decrease from Stigma of Suicide Scale (Short Version)
Time Frame: Baseline, immediately after intervention, 2 week follow-up
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This three-factor scale measures stigma towards people who die by suicide.
This short version consists of 16-items.
Each item consists of a one-word descriptor of a person who dies by suicide, rated on a 5-point Likert scale from (1) strongly disagree to (5) strongly agree.
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Baseline, immediately after intervention, 2 week follow-up
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Decrease from baseline in scores on The Emotional Reactions Scale
Time Frame: Baseline, immediately after intervention, 2 week follow-up
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This scale was adapted from the original Emotional Reactions to the Mentally Ill Scale to include a suicide ideation case.
This 9-item scale includes two vignettes of a person with SIA to assess emotional reaction to the scenario.
Each item is rated in a 5-point Likert scale.
|
Baseline, immediately after intervention, 2 week follow-up
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Increase from baseline in scores on the Cross-Cultural Care Scale (CCCS)
Time Frame: Baseline, immediately after intervention, 2 week follow-up
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This adaptation of the Cross- Cultural Care Scale which assesses preparedness to treat diverse patient populations.
This 19-item scale is rated in a 5-point Likert format.
|
Baseline, immediately after intervention, 2 week follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention Contamination Inventory
Time Frame: Immediately after intervention, 2 week follow-up
|
This inventory includes four closed- and open-ended questions addressing the following contamination-related areas: receiving information on SMI/SIA topics from another source, participation in other SMI/SIA courses or workshops, and type of information received in them.
Via coding of both the closed and open-ended question contamination will be defined via yes-no variable (0 = no contamination reported; 1 = contamination reported).
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Immediately after intervention, 2 week follow-up
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Intervention Acceptability Questionnaire
Time Frame: Immediately after intervention, 2 week follow-up
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This questionnaire includes 16 items addressing participants' satisfaction with the intervention's format, content, and delivery.
The study team has successfully used this questionnaire in intervention development studies and has adapted it for the proposed study.
|
Immediately after intervention, 2 week follow-up
|
Social Desirability Scale
Time Frame: Immediately after intervention, 2 week follow-up
|
This scale is composed of 11 items rated on a 4-point Likert scale ranging from (1) "Strongly Disagree" to (4) "Strongly Agree".
This measure has excellent reliability coefficients with Cronbach alphas of .86 when used with medical students.
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Immediately after intervention, 2 week follow-up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Eliut Rivera-Segarra, Ph.D, Ponce Health Sciences University
- Principal Investigator: Nelson Varas-Diaz, Ph.D, Florida International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- 1R34MH120179-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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