StigmatizationNCT05325320
Intervention to Reduce Serious Mental Illness and Suicide Stigma Among Medical Students
A study testing SMI/SIA Stigma Reduction Intervention and Disaster Preparedness Course in people with Stigmatization and Clinical Competence, run by Ponce Medical School Foundation, Inc. at 2 sites in 2 countries.
Trial summary
The team aims to develop and test the efficacy of a serious mental illness (SMI) and suicide ideation and attempt (SIA) stigma reduction intervention for medical students. The team expects that after intervention exposure, relative to control group, participants in the experimental condition will manifest more… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stigmatization, Clinical Competence
- What is being tested?
- SMI/SIA Stigma Reduction Intervention and Disaster Preparedness Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Apr 2022to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medical student currently in third year of medical school training
Who cannot join
- Do not speak English
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Not yet recruiting
Florida International University
Miami, Florida, 33199
Nelson Varas Díaz, Ph.D, 305-348-2618
Puerto Rico1 site, 1 recruiting
- Recruiting
Ponce Health Sciences University
Ponce
Eliut Rivera Segarra, Ph.D, 787-840-2575
About this study
Official title: Reducing Serious Mental Illness and Suicide Stigma Among Medical Students
The team aims to develop and test the efficacy of a serious mental illness (SMI) and suicide ideation and attempt (SIA) stigma reduction intervention for medical students. The team expects that after intervention exposure, relative to control group, participants in the experimental condition will manifest more favorable change in knowledge, attitudes, and behaviors.
Read the 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.
- Conditions
- Stigmatization, Clinical Competence
- Being tested
- SMI/SIA Stigma Reduction Intervention, Disaster Preparedness Course
- Medical subject headings
- Stereotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMI/SIA Stigma Reduction InterventionBehavioural
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.
Disaster Preparedness CourseOther
Online course designed to improve professionals' skills and competencies for engaging in disaster preparedness.
| Study group | Role | What they receive |
|---|---|---|
| Stigma Reduction Intervention | Experimental | Participants randomized to the experimental condition will receive the SMI/SIA Stigma Reduction Intervention. Receives: Behavioral: SMI/SIA Stigma Reduction Intervention |
| Disaster Preparedness Course | Other | Participants randomized to the control condition will receive a Disaster Preparedness Course, addressing the basics of natural disaster preparedness. Receives: Other: Disaster Preparedness Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase from baseline in scores on the Behavioral Health Skills Inventory (BHSI)
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.
Measured: Baseline, immediately after intervention, 2 week follow-up
Secondary outcomes (6)
Increase from baseline in scores on the Serious Mental Illness Literacy Scale
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.
Measured: Baseline, immediately after intervention, 2 week follow-up
Increase from baseline in scores on the Literacy of Suicide Scale (LOSS)
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.
Measured: Baseline, immediately after intervention, 2 week follow-up
Decrease from baseline in scores on The Mental Health Stigma Scale for Health Professionals
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).
Measured: Baseline, immediately after intervention, 2 week follow-up
Decrease from Stigma of Suicide Scale (Short Version)
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.
Measured: Baseline, immediately after intervention, 2 week follow-up
Decrease from baseline in scores on The Emotional Reactions Scale
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.
Measured: Baseline, immediately after intervention, 2 week follow-up
Increase from baseline in scores on the Cross-Cultural Care Scale (CCCS)
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.
Measured: Baseline, immediately after intervention, 2 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start6 Apr 2022
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StigmatizationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ponce Medical School Foundation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Eliut Rivera-Segarra, Ph.D, Principal investigator, Ponce Health Sciences UniversityNelson Varas-Diaz, Ph.D, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325320
- Sponsor's protocol ID
- 1R34MH120179-01A1
- Other IDs
- 1R34MH120179-01A1
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Serious Mental Illness and Suicide Stigma Among Medical Students
- ClinicalTrials.gov ID
- NCT05325320
- Acronym / sponsor ID
- 1R34MH120179-01A1
- Conditions
- Stigmatization, Clinical Competence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Ponce Medical School Foundation, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 13 Apr 2022 (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 team aims to develop and test the efficacy of a serious mental illness (SMI) and suicide ideation and attempt (SIA) stigma reduction intervention for medical students. The team expects that after intervention exposure, relative to control group, participants in the experimental condition will manifest more favorable change in knowledge, attitudes, and behaviors.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stigma Reduction Intervention | Experimental | Behavioral: SMI/SIA Stigma Reduction InterventionParticipants randomized to the experimental condition will receive the SMI/SIA Stigma Reduction Intervention. |
| Disaster Preparedness Course | Other | Other: Disaster Preparedness CourseParticipants randomized to the control condition will receive a Disaster Preparedness Course, addressing the basics of natural disaster preparedness. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medical student currently in third year of medical school training
Key exclusion criteria (1 listed)
- Do not speak English
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 |
|---|---|---|
| SMI/SIA Stigma Reduction InterventionOnline 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. | Behavioural | Stigma Reduction Intervention |
| Disaster Preparedness CourseOnline course designed to improve professionals' skills and competencies for engaging in disaster preparedness. | Other | Disaster Preparedness Course |
Primary outcome
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.
6 secondary outcomes
Increase from baseline in scores on the Serious Mental Illness Literacy Scale
Time frame: Baseline, immediately after intervention, 2 week follow-up
Increase from baseline in scores on the Literacy of Suicide Scale (LOSS)
Time frame: Baseline, immediately after intervention, 2 week follow-up
Decrease from baseline in scores on The Mental Health Stigma Scale for Health Professionals
Time frame: Baseline, immediately after intervention, 2 week follow-up
Decrease from Stigma of Suicide Scale (Short Version)
Time frame: Baseline, immediately after intervention, 2 week follow-up
Decrease from baseline in scores on The Emotional Reactions Scale
Time frame: Baseline, immediately after intervention, 2 week follow-up
Increase from baseline in scores on the Cross-Cultural Care Scale (CCCS)
Time frame: Baseline, immediately after intervention, 2 week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Eliut Rivera-Segarra, Ph.D principal investigator
Ponce Health Sciences University
Nelson Varas-Diaz, Ph.D principal investigator
Florida International University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMI/SIA Stigma Reduction Intervention and Disaster Preparedness Course in people with Stigmatization and Clinical Competence, run by Ponce Medical School Foundation, Inc. at 2 sites in 2 countries.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eliut Rivera-Segarra, Ph.D (787-840-2575, elrivera@psm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase from baseline in scores on the Behavioral Health Skills Inventory (BHSI) (time frame: Baseline, immediately after intervention, 2 week follow-up). 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 19 May 2022.