Mental Health IssueNCT05925062
Effect of a Mental Wellness App on the Mental Wellness of Medical and Nurse Anesthesia Students
A study testing QActual in people with Mental Health Issue, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- QActual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2024to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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.
- Conditions
- Mental Health Issue
- Being tested
- QActual
- Keywords
- stress levels, anxiety, depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QActualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: QActual |
| Control Arm - Subjects not using App | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Year 1
Secondary outcomes (4)
Number of crisis alerts triggered
Number of crisis alerts triggered
Measured: Year 1
Number of daily wellness check-ins completed
Number of daily wellness check-ins completed
Measured: Year 1
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
Measured: Year 1
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
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study startJul 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Why it stopped: The study team concluded that it was unlikely that the study population would be adherent to the tool planned for the study and therefore the study would not be valuable to pursue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James R Beardsley, PharmD, BCPS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925062
- Sponsor's protocol ID
- IRB00098397
- Status last verified
- Jul 2024
- First submitted
- 20 Jun 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Mental Wellness App on the Mental Wellness of Medical and Nurse Anesthesia Students
- ClinicalTrials.gov ID
- NCT05925062
- Acronym / sponsor ID
- IRB00098397
- Conditions
- Mental Health Issue
- Keywords
- stress levels, anxiety, depression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study team concluded that it was unlikely that the study population would be adherent to the tool planned for the study and therefore the study would not be valuable to pursue.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| QActual | Experimental | Behavioral: QActualQActual 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. |
| Control Arm - Subjects not using App | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QActualQActual 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. | Behavioural | QActual |
Primary outcome
Patient Health Questionnaire-9 (PHQ-9) scores
Time frame: 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.
Patient Health Questionnaire-9 (PHQ-9) scores
Time frame: 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.
Patient Health Questionnaire-9 (PHQ-9) scores
Time frame: 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.
Patient Health Questionnaire-9 (PHQ-9) scores
Time frame: 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.
Patient Health Questionnaire-9 (PHQ-9) scores
Time frame: 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.
4 secondary outcomes
Number of crisis alerts triggered
Time frame: Year 1
Number of daily wellness check-ins completed
Time frame: Year 1
Satisfaction with the app Scores
Time frame: Year 1
Time periods associated with lower daily wellness check scores
Time frame: Year 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James R Beardsley, PharmD, BCPS principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QActual in people with Mental Health Issue, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) scores (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.