Effect of a Mental Wellness App on the Mental Wellness of Medical and Nurse Anesthesia Students

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05925062
Collaborator
(none)
50
1
2
13
3.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: QActual
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
This will be a non-randomized, control-group, year-long study exploring the impact of a mental wellness app on various aspects of mental wellness in first-year medical students and second-year nurse anesthesia (CRNA) students from Wake Forest University School of Medicine (WFUSM) during the 2023 - 2024 academic year (approximately July 2023 - June 2024).This will be a non-randomized, control-group, year-long study exploring the impact of a mental wellness app on various aspects of mental wellness in first-year medical students and second-year nurse anesthesia (CRNA) students from Wake Forest University School of Medicine (WFUSM) during the 2023 - 2024 academic year (approximately July 2023 - June 2024).
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effect of a Mental Wellness App on the Mental Wellness of Medical and Nurse Anesthesia Students
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

No Intervention: Control Arm - Subjects not using App

No intervention

Outcome Measures

Primary Outcome Measures

  1. Patient Health Questionnaire-9 (PHQ-9) scores [Baseline]

    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.

  2. Patient Health Questionnaire-9 (PHQ-9) scores [Month 3]

    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.

  3. Patient Health Questionnaire-9 (PHQ-9) scores [Month 6]

    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.

  4. Patient Health Questionnaire-9 (PHQ-9) scores [Month 9]

    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.

  5. Patient Health Questionnaire-9 (PHQ-9) scores [Year 1]

    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.

Secondary Outcome Measures

  1. Number of crisis alerts triggered [Year 1]

    Number of crisis alerts triggered

  2. Number of daily wellness check-ins completed [Year 1]

    Number of daily wellness check-ins completed

  3. Satisfaction with the app Scores [Year 1]

    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

  4. Time periods associated with lower daily wellness check scores [Year 1]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157

Sponsors and Collaborators

  • Wake Forest University Health Sciences

Investigators

  • Principal Investigator: James R Beardsley, PharmD, BCPS, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT05925062
Other Study ID Numbers:
  • IRB00098397
First Posted:
Jun 29, 2023
Last Update Posted:
Jun 29, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wake Forest University Health Sciences

Study Results

No Results Posted as of Jun 29, 2023