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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05925062
Other study ID # IRB00098397
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date August 2024

Study information

Verified date August 2023
Source Wake Forest University Health Sciences
Contact James R Beardsley, PharmD, BCPS
Phone 336.713.3412
Email jbeardsl@wakehealth.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Mental health issues and suicide are becoming increasingly common among health care trainees and providers. Suicide is the leading cause of death among male medical residents and the second leading cause of death among female residents.


Description:

Training programs are usually very rigorous, caring for patients is stressful, and those who care for others often feel that they can't or shouldn't admit that they need care themselves. Unfortunately, there is often a stigma associated with mental illness, and trainees may feel that admitting that they struggle could damage their careers. The need exists for easily accessible, immediate, crisis support for medical trainees who are experiencing a mental health crisis. Although the effectiveness of mental health apps has been evaluated in college students, there is very little data assessing their use in medical and nurse anesthesia students. The purpose of this study is to evaluate the effect of a mental wellness app on the mental wellness of medical and nurse anesthesia students.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - first-year medical students and second-year nurse anesthesia (CRNA) students from Wake Forest University School of Medicine during the 2023 - 2024 academic year (approximately July 2023 - June 2024). Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
QActual
QActual is a phone-based app that offers peer-to-peer support, tracks mental wellness self-assessments, and provides support to users who are in crisis.

Locations

Country Name City State
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Health Questionnaire-9 (PHQ-9) scores Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression. Baseline
Primary Patient Health Questionnaire-9 (PHQ-9) scores Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression. Month 3
Primary Patient Health Questionnaire-9 (PHQ-9) scores Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression. Month 6
Primary Patient Health Questionnaire-9 (PHQ-9) scores Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression. Month 9
Primary Patient Health Questionnaire-9 (PHQ-9) scores Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression. Year 1
Secondary Number of crisis alerts triggered Number of crisis alerts triggered Year 1
Secondary Number of daily wellness check-ins completed Number of daily wellness check-ins completed Year 1
Secondary Satisfaction with the app Scores Satisfaction with the app scores - a global scale that is used to assess attitudes and views. It is a scale with 5 answer options which has two utmost poles and a neutral option linked with intermediate answer options. For example, agree, fully agree, neither agree nor disagree, disagree, and fully disagree Year 1
Secondary Time periods associated with lower daily wellness check scores Time periods associated with lower daily wellness check scores (these will be compared to the academic calendar to detect any correlations) - The mean daily wellness check scores for Medical students and CRNA students will be retrospectively reviewed. Days where the mean score for the day differ significantly from the mean score for the year will be recorded Year 1
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