NCT05325320

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.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
2 countries

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 6, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

May 19, 2022

Status Verified

April 1, 2022

Enrollment Period

1.1 years

First QC Date

April 5, 2022

Last Update Submit

May 12, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, immediately after intervention, 2 week follow-up

Secondary Outcomes (6)

  • Increase from baseline in scores on the Serious Mental Illness Literacy Scale

    Baseline, immediately after intervention, 2 week follow-up

  • Increase from baseline in scores on the Literacy of Suicide Scale (LOSS)

    Baseline, immediately after intervention, 2 week follow-up

  • Decrease from baseline in scores on The Mental Health Stigma Scale for Health Professionals

    Baseline, immediately after intervention, 2 week follow-up

  • Decrease from Stigma of Suicide Scale (Short Version)

    Baseline, immediately after intervention, 2 week follow-up

  • Decrease from baseline in scores on The Emotional Reactions Scale

    Baseline, immediately after intervention, 2 week follow-up

  • +1 more secondary outcomes

Other Outcomes (3)

  • Intervention Contamination Inventory

    Immediately after intervention, 2 week follow-up

  • Intervention Acceptability Questionnaire

    Immediately after intervention, 2 week follow-up

  • Social Desirability Scale

    Immediately after intervention, 2 week follow-up

Study Arms (2)

Stigma Reduction Intervention

EXPERIMENTAL

Participants randomized to the experimental condition will receive the SMI/SIA Stigma Reduction Intervention.

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.

Other: Disaster Preparedness Course

Interventions

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.

Stigma Reduction Intervention

Online course designed to improve professionals' skills and competencies for engaging in disaster preparedness.

Disaster Preparedness Course

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical student currently in third year of medical school training

You may not qualify if:

  • Do not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Florida International University

Miami, Florida, 33199, United States

NOT YET RECRUITING

Ponce Health Sciences University

Ponce, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Stereotyping

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Eliut Rivera-Segarra, Ph.D

    Ponce Health Sciences University

    PRINCIPAL INVESTIGATOR
  • Nelson Varas-Diaz, Ph.D

    Florida International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliut Rivera-Segarra, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 13, 2022

Study Start

April 6, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

May 19, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations