The COVID-19 and Healthcare Workers: An Active Intervention

Sponsor
Research Foundation for Mental Hygiene, Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT04497415
Collaborator
(none)
350
Enrollment
1
Location
2
Arms
3.3
Actual Duration (Months)
105.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Video-Based intervention
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Health Services Research
Official Title:
The COVID-19 and Healthcare Workers: An Active Intervention
Actual Study Start Date :
Oct 21, 2020
Actual Primary Completion Date :
Nov 30, 2020
Actual Study Completion Date :
Jan 30, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Video-based intervention

A brief video about coping with COVID-19 stress presented to the participants

Other: Video-Based intervention
Three minutes video of a nurse that shares her personal story

No Intervention: Assessment only

Control

Outcome Measures

Primary Outcome Measures

  1. Help-seeking Behavior [Assessed 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

  2. Generalized Anxiety Disorder-7 (GAD-7) [Assessed at baseline, 14-day follow-up, and 30-day follow-up]

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

  3. Patient Health Questionnaire-9 (PHQ-9) [Assessed at baseline, 14-day follow-up, and 30-day follow-up]

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

  4. Primary Care Posttraumatic Stress Disorder (PC-PTSD) Screen [Assessed at baseline, 14-day follow-up, and 30-day follow-up]

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

  5. Moral Injury Events Scale (MIES) [Assessed at baseline, 14-day follow-up, and 30-day follow-up]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1New York State Psychiatric InstituteNew YorkNew YorkUnited States10032

Sponsors and Collaborators

  • Research Foundation for Mental Hygiene, Inc.

Investigators

  • Principal Investigator: Yuval Neria, PhD, Columbia University and NYSPI

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Yuval Y Neria, Professor of medical psychology, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier:
NCT04497415
Other Study ID Numbers:
  • 8032
First Posted:
Aug 4, 2020
Last Update Posted:
Jan 14, 2022
Last Verified:
Jan 1, 2022
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

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleVideo-based InterventionAssessment Only
Arm/Group DescriptionA 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 storyControl
Period Title: Overall Study
STARTED229121
Post-intervention Assessment (Day 1)229121
First Follow-up Assessment (Day 14)195102
COMPLETED18694
NOT COMPLETED4327

Baseline Characteristics

Arm/Group TitleVideo-based InterventionAssessment OnlyTotal
Arm/Group DescriptionA 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 storyControlTotal of all reporting groups
Overall Participants229121350
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
35.3
(11.5)
33.8
(11.5)
34.8
(11.5)
Sex: Female, Male (Count of Participants)
Female
165
72.1%
95
78.5%
260
74.3%
Male
64
27.9%
26
21.5%
90
25.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
28
12.2%
6
5%
34
9.7%
Not Hispanic or Latino
201
87.8%
115
95%
316
90.3%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
3
1.3%
2
1.7%
5
1.4%
Asian
23
10%
15
12.4%
38
10.9%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
31
13.5%
15
12.4%
46
13.1%
White
170
74.2%
86
71.1%
256
73.1%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
2
0.9%
3
2.5%
5
1.4%
Region of Enrollment (participants) [Number]
United States
229
100%
121
100%
350
100%
Occupation (Count of Participants)
Nurse
156
68.1%
81
66.9%
237
67.7%
Physician
37
16.2%
15
12.4%
52
14.9%
EMT
20
8.7%
10
8.3%
30
8.6%
Other
16
7%
15
12.4%
31
8.9%
Exposure to COVID-19 (Count of Participants)
Count of Participants [Participants]
105
45.9%
46
38%
151
43.1%

Outcome Measures

1. Primary Outcome
TitleHelp-seeking Behavior
DescriptionMeasured 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 FrameAssessed at baseline and post-intervention (both day 1), first follow-up (day 14), and second follow-up (day 30)

Outcome Measure Data

Analysis Population Description
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).
Arm/Group TitleVideo-based InterventionAssessment Only
Arm/Group DescriptionA 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 storyControl
Measure Participants229121
Baseline
8.2
8.5
Post-intervention
9.3
8.7
First follow-up (day 14)
9.7
9.3
Second follow-up (day 30)
9.4
9.1
2. Primary Outcome
TitleGeneralized Anxiety Disorder-7 (GAD-7)
DescriptionMeasured with the GAD-7 scale - total scores range from 0 to 21, with higher scores indicating greater self-reported anxiety
Time FrameAssessed at baseline, 14-day follow-up, and 30-day follow-up

Outcome Measure Data

Analysis Population Description
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).
Arm/Group TitleVideo-based InterventionAssessment Only
Arm/Group DescriptionA 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 storyControl
Measure Participants229121
Baseline (day 1)
7.6
(5.9)
6.7
(6.1)
First follow-up (day 14)
6.9
(6.0)
5.9
(5.2)
Second follow-up (day 30)
6.5
(5.7)
5.4
(5.3)
3. Primary Outcome
TitlePatient Health Questionnaire-9 (PHQ-9)
DescriptionMeasured with PHQ-9 - total scores range from 0 to 27; higher scores indicate greater self-reported depression
Time FrameAssessed at baseline, 14-day follow-up, and 30-day follow-up

Outcome Measure Data

Analysis Population Description
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).
Arm/Group TitleVideo-based InterventionAssessment Only
Arm/Group DescriptionA 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 storyControl
Measure Participants229121
Baseline (day 1)
7.9
(6.6)
6.6
(5.6)
First follow-up (day 14)
7.4
(6.7)
6.0
(5.7)
Second follow-up (day 30)
7.0
(6.2)
5.4
(5.7)
4. Primary Outcome
TitlePrimary Care Posttraumatic Stress Disorder (PC-PTSD) Screen
DescriptionMeasured with the PC-PTSD for DSM-5 - total scores range from 0 to 5, with higher scores indicating greater self-reported PTSD symptoms
Time FrameAssessed at baseline, 14-day follow-up, and 30-day follow-up

Outcome Measure Data

Analysis Population Description
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).
Arm/Group TitleVideo-based InterventionAssessment Only
Arm/Group DescriptionA 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 storyControl
Measure Participants229121
Baseline (day 1)
1.9
(1.6)
1.8
(1.7)
First follow-up (day 14)
1.8
(1.6)
1.2
(1.5)
Second follow-up (day 30)
1.7
(1.7)
1.4
(1.6)
5. Primary Outcome
TitleMoral Injury Events Scale (MIES)
DescriptionMeasured with the MIES - scores range from 9 to 36, with higher scores indicating greater moral injury
Time FrameAssessed at baseline, 14-day follow-up, and 30-day follow-up

Outcome Measure Data

Analysis Population Description
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).
Arm/Group TitleVideo-based InterventionAssessment Only
Arm/Group DescriptionA 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 storyControl
Measure Participants229121
Baseline (day 1)
18.1
(6.4)
17.1
(6.6)
First follow-up (day 14)
18.1
(6.8)
16.5
(6.3)
Second follow-up (day 30)
17.5
(6.7)
16.5
(6.9)

Adverse Events

Time Frame30 days
Adverse Event Reporting Description Our definition of adverse event and serious adverse event does not differ from the clinicaltrials.gov definition.
Arm/Group TitleVideo-based InterventionAssessment Only
Arm/Group DescriptionA 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 storyControl
All Cause Mortality
Video-based InterventionAssessment Only
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/229 (0%) 0/121 (0%)
Serious Adverse Events
Video-based InterventionAssessment Only
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/229 (0%) 0/121 (0%)
Other (Not Including Serious) Adverse Events
Video-based InterventionAssessment Only
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/229 (0%) 0/121 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleYuval Y. Neria
OrganizationNew York State Psychiatric Institute
Phone646-774-8092
Emailny126@cumc.columbia.edu
Responsible Party:
Yuval Y Neria, Professor of medical psychology, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier:
NCT04497415
Other Study ID Numbers:
  • 8032
First Posted:
Aug 4, 2020
Last Update Posted:
Jan 14, 2022
Last Verified:
Jan 1, 2022