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Behavioral Intervention

Experimental Group for Emotional Distress

N/A

Waitlist Available

Led By Venkat Bhat, MD MSc

Research Sponsored by Unity Health Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 3.5 months

Awards & highlights

Study Summary

This trial will assess a digital intervention suite to reduce stress & distress in frontline healthcare workers during the COVID pandemic.

Eligible Conditions

Nursing Stress Response
Emotional Distress
Stress Reaction

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 3.5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 3.5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3.5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Moral Injury Outcome Scale (MIOS-4; 4 item scale)

Subjective Units of Distress Scale (SUDS)

Secondary outcome measures

Generalized Anxiety Disorder Scale (GAD-2; 2 item scale)

Generalized Anxiety Disorder Scale (GAD-7; 7 item scale)

Moral Injury Outcome Scale (MIOS-14; 22 item scale)

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental GroupExperimental Treatment1 Intervention

During the duration of the study, all participants will use the Digital Intervention Suite (a web-based component, a VR platform, and wearable device) to measure passive and active data, such as: psychological variables (e.g., moral distress, anxiety, and depression) and physiological variables (e.g., heart rate and sleep).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Digital Intervention Group

2023

N/A

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Toronto Metropolitan UniversityUNKNOWN

83 Previous Clinical Trials

10,817 Total Patients Enrolled

1 Trials studying Emotional Distress

15 Patients Enrolled for Emotional Distress

University of TorontoOTHER

689 Previous Clinical Trials

1,018,543 Total Patients Enrolled

1 Trials studying Emotional Distress

15 Patients Enrolled for Emotional Distress

University of Ontario Institute of TechnologyOTHER

7 Previous Clinical Trials

1,306 Total Patients Enrolled

1 Trials studying Emotional Distress

15 Patients Enrolled for Emotional Distress

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum number of participants allowed in this clinical investigation?

"Affirmative. Clinical information hosted on clinicaltrials.gov supports that this medical trial, initially posted on May 1st 2023, is actively looking for participants. One hundred individuals from a single location need to be recruited."

Answered by AI

Are there any openings available for potential participants in this research project?

"According to the information on clinicaltrials.gov, this research is actively seeking volunteers. It was first published on May 1st 2023 and underwent its most recent update June 19th of that same year."

Answered by AI

What objectives will this experiment seek to elucidate?

"The primary assessment of this trial, which will span over ~3.5 months, is the Moral Injury Outcome Scale (MIOS-4; 4 item scale). Secondary outcomes include Generalized Anxiety Disorder Scale (GAD-7; 7 item scale) and (GAD-2; 2 item scale), as well as Patient Health Questionnaire (PHQ-9; 9 item scale). Every Saturday for 3.5 months participants are expected to answer GAD-7 & PHQ through a web based platform while GAD -2 must be answered on Mondays and Thursdays. Scores range from 0 to 6 or 27 respectively with"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Digital Interventions to Understand and Mitigate Stress Response

2023. "Digital Interventions to Understand and Mitigate Stress Response". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05923398.