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

NCT05925062 | Withdrawn

• 1 other identifier: IRB00098397
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Issue

Keywords

stress levels; anxiety; depression

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Number of crisis alerts triggered

  Year 1

• Number of daily wellness check-ins completed

  Year 1

• Satisfaction with the app Scores

  Year 1

• Time periods associated with lower daily wellness check scores

  Year 1

Study Arms (2)

QActual

EXPERIMENTAL

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

Control Arm - Subjects not using App

NO INTERVENTION

No intervention

Interventions

QActual BEHAVIORAL

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.

QActual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• none

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• James R Beardsley, PharmD, BCPS

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: June 29, 2023
• Study Start: July 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)