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The COVID-19 and Healthcare Workers: An Active Intervention

The COVID-19 and Healthcare Workers: An Active Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04497415
Enrollment
350
Registered
2020-08-04
Start date
2020-10-21
Completion date
2021-01-30
Last updated
2022-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brief Video-based Intervention, Non Intervention Control

Brief summary

The overarching goal of this study is to examine the efficacy of a brief video intervention in reducing stigma and fear, and improving help-seeking behavior, among health care providers (N=1,200), with pre- post- and follow-up assessments (at day 14 and day 30). Participants will be recruited via Amazon Turk and randomly assigned to either a) a video-based intervention (day 1 and a booster intervention of the same content on day 14 of the study) featuring the personal story of a health care provider during COVID-19 pandemic, his/her struggles and barriers to care, (b) video-based intervention (day 1 only), and a written description of the same story on day 14 (c) no-intervention control arm (questionnaires only). The invetsigators aim to (1) determine whether video-based intervention reduce stigma and fear, and increase help-seeking behavior in relation to COVID-19 among health care providers, and (2) compare high-risk areas (e.g., NY) to low-risk areas (e.g., Montana) on intervention outcomes, and (3) test whether symptoms of depression, anxiety, PTSD and Moral Injury (measured by the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder (GAD-7), the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) and the Moral Injury Events Scale (MIES)) would change over time.

Detailed description

Coronavirus disease 2019 (COVID-19) has widely and rapidly spread around the world. To effectively respond to the COVID-19 outbreak, various governments have implemented rapid and comprehensive public health emergency interventions that include social restrictions and quarantines, which is the separation and restriction of movement of people who might have been exposed to the virus. While the physical risk (e.g. pneumonia, respiratory breakdown) is getting the most scientific and clinical attention, this outbreak also has significant mental health risks and extreme psychological fear-related responses. Psychological responses to previous large-scale outbreaks, particularly to the Ebola Virus Disease (EVD) epidemic during 2014-2016, provide insight into the potential impact of rapidly spreading diseases on mental health problems. During the Ebola outbreak, fear-related behaviors such as stigmatizing infected survivors and ignoring medical procedures impeded public health efforts and negatively affected the recovery of survivors. Anxiety, posttraumatic stress disorder (PTSD), and depression were found in nearly half of the EVD survivors and their contacts. The COVID-19 outbreak exceeds the scope and magnitude of most previous disasters over the last 100 years. It entails a blend of risk factors for both acute and long-term mental health problems. Data that is started to emerge from the COVID-19 outbreak, suggest that front lines health workers (doctors; nurses) are particularly at risk. A recent study in 1257 health care workers from 34 hospitals, conducted between January 29 to February 3, 2020, revealed that more than half (50.4%) of the health workers were screened positive for depression, 44.6% for anxiety, and 34.0% for insomnia. Consistent with previous disaster studies a dose-response relationship was found between the level of exposure and outcomes. Others may develop a moral injury, profound psychological distress which results in actions, or the lack of them, which violet one's moral or ethical code. Given the magnitude of the COVID-19 outbreak, its risk to physical and mental health, an effective and timely response is essential to address the psychosocial needs associated with the ongoing exposure to disease, death, and distress among health care providers, across low and high risks areas. Many health care providers reluctant to seek support from friends and family, as well as mental health care due to stigma and fear (e.g., it would be too embarrassing, I would be seen as week). Despite enduring symptoms, they may wait months to years before they seek help. Among reasons to avoid seeking mental health care, individuals report mistrust in mental health providers, being seen as weak or stereotyped as crazy, and a belief that they may be responsible for having mental health problems. Applying strategies to reduce stigma and fear towards mental health care and improve help-seeking behavior may ameliorate impaired functioning and reduce risks for long-term psychiatric illness. Previous studies have shown that social contact is the most effective type of intervention to reduce stigma- related attitudes and to improve help-seeking behavior. Social contact involves interpersonal contact with members of the stigmatized group: members of the general public who meet and interact with individuals who suffer from stress, fear, depression, or anxiety and seek mental health care, are likely to lessen their stigma. Corrigan has identified the most important ingredients of contact-based programs: an empowered presenter with lived experience who attains his/her goals (e.g., I was able to fight the depression/distress that I had following the COVID-19). While both direct, in-person social contact and indirect, video-based social contact have effectively improved attitudes toward mental issues and care, the latter can be implemented on a larger scale, use a minimal resource and easily disseminated.

Interventions

Three minutes video of a nurse that shares her personal story

Sponsors

Research Foundation for Mental Hygiene, Inc.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

English speakers Healthcare workers aged 18-80 and residents of the USA.

Exclusion criteria

Non-English speakers, non-healthcare workers, age less than 18 or more than 80, non-US residents

Design outcomes

Primary

MeasureTime frameDescription
Help-seeking BehaviorAssessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)Measured with the Attitudes Towards Seeking Professional Psychological Help Scale (ATSPPH) - total scores range from 3 to 12, with higher scores indicating greater treatment-seeking intentions
Generalized Anxiety Disorder-7 (GAD-7)Assessed at baseline, 14-day follow-up, and 30-day follow-upMeasured with the GAD-7 scale - total scores range from 0 to 21, with higher scores indicating greater self-reported anxiety
Patient Health Questionnaire-9 (PHQ-9)Assessed at baseline, 14-day follow-up, and 30-day follow-upMeasured with PHQ-9 - total scores range from 0 to 27; higher scores indicate greater self-reported depression
Primary Care Posttraumatic Stress Disorder (PC-PTSD) ScreenAssessed at baseline, 14-day follow-up, and 30-day follow-upMeasured with the PC-PTSD for DSM-5 - total scores range from 0 to 5, with higher scores indicating greater self-reported PTSD symptoms
Moral Injury Events Scale (MIES)Assessed at baseline, 14-day follow-up, and 30-day follow-upMeasured with the MIES - scores range from 9 to 36, with higher scores indicating greater moral injury

Countries

United States

Participant flow

Participants by arm

ArmCount
Video-based Intervention
A brief video about coping with COVID-19 stress presented to the participants Video-Based intervention: Three minutes video of a nurse that shares her personal story
229
Assessment Only
Control
121
Total350

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up4327

Baseline characteristics

CharacteristicTotalVideo-based InterventionAssessment Only
Age, Continuous34.8 years
STANDARD_DEVIATION 11.5
35.3 years
STANDARD_DEVIATION 11.5
33.8 years
STANDARD_DEVIATION 11.5
Ethnicity (NIH/OMB)
Hispanic or Latino
34 Participants28 Participants6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
316 Participants201 Participants115 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Exposure to COVID-19151 Participants105 Participants46 Participants
Occupation
EMT
30 Participants20 Participants10 Participants
Occupation
Nurse
237 Participants156 Participants81 Participants
Occupation
Other
31 Participants16 Participants15 Participants
Occupation
Physician
52 Participants37 Participants15 Participants
Race (NIH/OMB)
American Indian or Alaska Native
5 Participants3 Participants2 Participants
Race (NIH/OMB)
Asian
38 Participants23 Participants15 Participants
Race (NIH/OMB)
Black or African American
46 Participants31 Participants15 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants2 Participants3 Participants
Race (NIH/OMB)
White
256 Participants170 Participants86 Participants
Region of Enrollment
United States
350 participants229 participants121 participants
Sex: Female, Male
Female
260 Participants165 Participants95 Participants
Sex: Female, Male
Male
90 Participants64 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2290 / 121
other
Total, other adverse events
0 / 2290 / 121
serious
Total, serious adverse events
0 / 2290 / 121

Outcome results

Primary

Generalized Anxiety Disorder-7 (GAD-7)

Measured with the GAD-7 scale - total scores range from 0 to 21, with higher scores indicating greater self-reported anxiety

Time frame: Assessed at baseline, 14-day follow-up, and 30-day follow-up

Population: Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).

ArmMeasureGroupValue (MEAN)Dispersion
Video-based InterventionGeneralized Anxiety Disorder-7 (GAD-7)Baseline (day 1)7.6 units on a scaleStandard Deviation 5.9
Video-based InterventionGeneralized Anxiety Disorder-7 (GAD-7)First follow-up (day 14)6.9 units on a scaleStandard Deviation 6
Video-based InterventionGeneralized Anxiety Disorder-7 (GAD-7)Second follow-up (day 30)6.5 units on a scaleStandard Deviation 5.7
Assessment OnlyGeneralized Anxiety Disorder-7 (GAD-7)Baseline (day 1)6.7 units on a scaleStandard Deviation 6.1
Assessment OnlyGeneralized Anxiety Disorder-7 (GAD-7)First follow-up (day 14)5.9 units on a scaleStandard Deviation 5.2
Assessment OnlyGeneralized Anxiety Disorder-7 (GAD-7)Second follow-up (day 30)5.4 units on a scaleStandard Deviation 5.3
Primary

Help-seeking Behavior

Measured with the Attitudes Towards Seeking Professional Psychological Help Scale (ATSPPH) - total scores range from 3 to 12, with higher scores indicating greater treatment-seeking intentions

Time frame: Assessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)

Population: Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).

ArmMeasureGroupValue (MEAN)
Video-based InterventionHelp-seeking BehaviorBaseline8.2 units on a scale
Video-based InterventionHelp-seeking BehaviorPost-intervention9.3 units on a scale
Video-based InterventionHelp-seeking BehaviorFirst follow-up (day 14)9.7 units on a scale
Video-based InterventionHelp-seeking BehaviorSecond follow-up (day 30)9.4 units on a scale
Assessment OnlyHelp-seeking BehaviorSecond follow-up (day 30)9.1 units on a scale
Assessment OnlyHelp-seeking BehaviorBaseline8.5 units on a scale
Assessment OnlyHelp-seeking BehaviorFirst follow-up (day 14)9.3 units on a scale
Assessment OnlyHelp-seeking BehaviorPost-intervention8.7 units on a scale
Primary

Moral Injury Events Scale (MIES)

Measured with the MIES - scores range from 9 to 36, with higher scores indicating greater moral injury

Time frame: Assessed at baseline, 14-day follow-up, and 30-day follow-up

Population: Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).

ArmMeasureGroupValue (MEAN)Dispersion
Video-based InterventionMoral Injury Events Scale (MIES)Baseline (day 1)18.1 units on a scaleStandard Deviation 6.4
Video-based InterventionMoral Injury Events Scale (MIES)First follow-up (day 14)18.1 units on a scaleStandard Deviation 6.8
Video-based InterventionMoral Injury Events Scale (MIES)Second follow-up (day 30)17.5 units on a scaleStandard Deviation 6.7
Assessment OnlyMoral Injury Events Scale (MIES)Baseline (day 1)17.1 units on a scaleStandard Deviation 6.6
Assessment OnlyMoral Injury Events Scale (MIES)First follow-up (day 14)16.5 units on a scaleStandard Deviation 6.3
Assessment OnlyMoral Injury Events Scale (MIES)Second follow-up (day 30)16.5 units on a scaleStandard Deviation 6.9
Primary

Patient Health Questionnaire-9 (PHQ-9)

Measured with PHQ-9 - total scores range from 0 to 27; higher scores indicate greater self-reported depression

Time frame: Assessed at baseline, 14-day follow-up, and 30-day follow-up

Population: Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).

ArmMeasureGroupValue (MEAN)Dispersion
Video-based InterventionPatient Health Questionnaire-9 (PHQ-9)Baseline (day 1)7.9 units on a scaleStandard Deviation 6.6
Video-based InterventionPatient Health Questionnaire-9 (PHQ-9)First follow-up (day 14)7.4 units on a scaleStandard Deviation 6.7
Video-based InterventionPatient Health Questionnaire-9 (PHQ-9)Second follow-up (day 30)7.0 units on a scaleStandard Deviation 6.2
Assessment OnlyPatient Health Questionnaire-9 (PHQ-9)Baseline (day 1)6.6 units on a scaleStandard Deviation 5.6
Assessment OnlyPatient Health Questionnaire-9 (PHQ-9)First follow-up (day 14)6.0 units on a scaleStandard Deviation 5.7
Assessment OnlyPatient Health Questionnaire-9 (PHQ-9)Second follow-up (day 30)5.4 units on a scaleStandard Deviation 5.7
Primary

Primary Care Posttraumatic Stress Disorder (PC-PTSD) Screen

Measured with the PC-PTSD for DSM-5 - total scores range from 0 to 5, with higher scores indicating greater self-reported PTSD symptoms

Time frame: Assessed at baseline, 14-day follow-up, and 30-day follow-up

Population: Fifty-three participants were lost to follow-up before first follow-up (day 14) and 70 were lost to follow-up before second follow-up (day 30).

ArmMeasureGroupValue (MEAN)Dispersion
Video-based InterventionPrimary Care Posttraumatic Stress Disorder (PC-PTSD) ScreenBaseline (day 1)1.9 units on a scaleStandard Deviation 1.6
Video-based InterventionPrimary Care Posttraumatic Stress Disorder (PC-PTSD) ScreenFirst follow-up (day 14)1.8 units on a scaleStandard Deviation 1.6
Video-based InterventionPrimary Care Posttraumatic Stress Disorder (PC-PTSD) ScreenSecond follow-up (day 30)1.7 units on a scaleStandard Deviation 1.7
Assessment OnlyPrimary Care Posttraumatic Stress Disorder (PC-PTSD) ScreenBaseline (day 1)1.8 units on a scaleStandard Deviation 1.7
Assessment OnlyPrimary Care Posttraumatic Stress Disorder (PC-PTSD) ScreenFirst follow-up (day 14)1.2 units on a scaleStandard Deviation 1.5
Assessment OnlyPrimary Care Posttraumatic Stress Disorder (PC-PTSD) ScreenSecond follow-up (day 30)1.4 units on a scaleStandard Deviation 1.6

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026