Intervention to Reduce Serious Mental Illness and Suicide Stigma Among Medical Students
Primary Purpose
Stigmatization, Clinical Competence
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SMI/SIA Stigma Reduction Intervention
Disaster Preparedness Course
Sponsored by
About this trial
This is an interventional health services research trial for Stigmatization
Eligibility Criteria
Inclusion Criteria:
- Medical student currently in third year of medical school training
Exclusion Criteria:
- Do not speak English
Sites / Locations
- Florida International University
- Ponce Health Sciences UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Stigma Reduction Intervention
Disaster Preparedness Course
Arm Description
Participants randomized to the experimental condition will receive the SMI/SIA Stigma Reduction Intervention.
Participants randomized to the control condition will receive a Disaster Preparedness Course, addressing the basics of natural disaster preparedness.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
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.
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.
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.
Full Information
NCT ID
NCT05325320
First Posted
April 5, 2022
Last Updated
May 12, 2022
Sponsor
Ponce Medical School Foundation, Inc.
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05325320
Brief Title
Intervention to Reduce Serious Mental Illness and Suicide Stigma Among Medical Students
Official Title
Reducing Serious Mental Illness and Suicide Stigma Among Medical Students
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ponce Medical School Foundation, Inc.
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stigmatization, Clinical Competence
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stigma Reduction Intervention
Arm Type
Experimental
Arm Description
Participants randomized to the experimental condition will receive the SMI/SIA Stigma Reduction Intervention.
Arm Title
Disaster Preparedness Course
Arm Type
Other
Arm Description
Participants randomized to the control condition will receive a Disaster Preparedness Course, addressing the basics of natural disaster preparedness.
Intervention Type
Behavioral
Intervention Name(s)
SMI/SIA Stigma Reduction Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Disaster Preparedness Course
Intervention Description
Online course designed to improve professionals' skills and competencies for engaging in disaster preparedness.
Primary Outcome Measure Information:
Title
Increase from baseline in scores on the Behavioral Health Skills Inventory (BHSI)
Description
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.
Time Frame
Baseline, immediately after intervention, 2 week follow-up
Secondary Outcome Measure Information:
Title
Increase from baseline in scores on the Serious Mental Illness Literacy Scale
Description
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.
Time Frame
Baseline, immediately after intervention, 2 week follow-up
Title
Increase from baseline in scores on the Literacy of Suicide Scale (LOSS)
Description
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.
Time Frame
Baseline, immediately after intervention, 2 week follow-up
Title
Decrease from baseline in scores on The Mental Health Stigma Scale for Health Professionals
Description
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).
Time Frame
Baseline, immediately after intervention, 2 week follow-up
Title
Decrease from Stigma of Suicide Scale (Short Version)
Description
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.
Time Frame
Baseline, immediately after intervention, 2 week follow-up
Title
Decrease from baseline in scores on The Emotional Reactions Scale
Description
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.
Time Frame
Baseline, immediately after intervention, 2 week follow-up
Title
Increase from baseline in scores on the Cross-Cultural Care Scale (CCCS)
Description
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.
Time Frame
Baseline, immediately after intervention, 2 week follow-up
Other Pre-specified Outcome Measures:
Title
Intervention Contamination Inventory
Description
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).
Time Frame
Immediately after intervention, 2 week follow-up
Title
Intervention Acceptability Questionnaire
Description
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.
Time Frame
Immediately after intervention, 2 week follow-up
Title
Social Desirability Scale
Description
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.
Time Frame
Immediately after intervention, 2 week follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Medical student currently in third year of medical school training
Exclusion Criteria:
Do not speak English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eliut Rivera-Segarra, Ph.D
Phone
787-840-2575
Email
elrivera@psm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliut Rivera-Segarra, Ph.D
Organizational Affiliation
Ponce Health Sciences University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nelson Varas-Diaz, Ph.D
Organizational Affiliation
Florida International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida International University
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nelson Varas Díaz, Ph.D
Phone
305-348-2618
Facility Name
Ponce Health Sciences University
City
Ponce
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eliut Rivera Segarra, Ph.D
Phone
787-840-2575
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intervention to Reduce Serious Mental Illness and Suicide Stigma Among Medical Students
We'll reach out to this number within 24 hrs