Brief Video-based Intervention, Non Intervention Control
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 350 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 43 | 27 |
Baseline characteristics
| Characteristic | Total | Video-based Intervention | Assessment Only |
|---|---|---|---|
| Age, Continuous | 34.8 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 Participants | 28 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 316 Participants | 201 Participants | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Exposure to COVID-19 | 151 Participants | 105 Participants | 46 Participants |
| Occupation EMT | 30 Participants | 20 Participants | 10 Participants |
| Occupation Nurse | 237 Participants | 156 Participants | 81 Participants |
| Occupation Other | 31 Participants | 16 Participants | 15 Participants |
| Occupation Physician | 52 Participants | 37 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 38 Participants | 23 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 46 Participants | 31 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 256 Participants | 170 Participants | 86 Participants |
| Region of Enrollment United States | 350 participants | 229 participants | 121 participants |
| Sex: Female, Male Female | 260 Participants | 165 Participants | 95 Participants |
| Sex: Female, Male Male | 90 Participants | 64 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 229 | 0 / 121 |
| other Total, other adverse events | 0 / 229 | 0 / 121 |
| serious Total, serious adverse events | 0 / 229 | 0 / 121 |
Outcome results
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Video-based Intervention | Generalized Anxiety Disorder-7 (GAD-7) | Baseline (day 1) | 7.6 units on a scale | Standard Deviation 5.9 |
| Video-based Intervention | Generalized Anxiety Disorder-7 (GAD-7) | First follow-up (day 14) | 6.9 units on a scale | Standard Deviation 6 |
| Video-based Intervention | Generalized Anxiety Disorder-7 (GAD-7) | Second follow-up (day 30) | 6.5 units on a scale | Standard Deviation 5.7 |
| Assessment Only | Generalized Anxiety Disorder-7 (GAD-7) | Baseline (day 1) | 6.7 units on a scale | Standard Deviation 6.1 |
| Assessment Only | Generalized Anxiety Disorder-7 (GAD-7) | First follow-up (day 14) | 5.9 units on a scale | Standard Deviation 5.2 |
| Assessment Only | Generalized Anxiety Disorder-7 (GAD-7) | Second follow-up (day 30) | 5.4 units on a scale | Standard Deviation 5.3 |
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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Video-based Intervention | Help-seeking Behavior | Baseline | 8.2 units on a scale |
| Video-based Intervention | Help-seeking Behavior | Post-intervention | 9.3 units on a scale |
| Video-based Intervention | Help-seeking Behavior | First follow-up (day 14) | 9.7 units on a scale |
| Video-based Intervention | Help-seeking Behavior | Second follow-up (day 30) | 9.4 units on a scale |
| Assessment Only | Help-seeking Behavior | Second follow-up (day 30) | 9.1 units on a scale |
| Assessment Only | Help-seeking Behavior | Baseline | 8.5 units on a scale |
| Assessment Only | Help-seeking Behavior | First follow-up (day 14) | 9.3 units on a scale |
| Assessment Only | Help-seeking Behavior | Post-intervention | 8.7 units on a scale |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Video-based Intervention | Moral Injury Events Scale (MIES) | Baseline (day 1) | 18.1 units on a scale | Standard Deviation 6.4 |
| Video-based Intervention | Moral Injury Events Scale (MIES) | First follow-up (day 14) | 18.1 units on a scale | Standard Deviation 6.8 |
| Video-based Intervention | Moral Injury Events Scale (MIES) | Second follow-up (day 30) | 17.5 units on a scale | Standard Deviation 6.7 |
| Assessment Only | Moral Injury Events Scale (MIES) | Baseline (day 1) | 17.1 units on a scale | Standard Deviation 6.6 |
| Assessment Only | Moral Injury Events Scale (MIES) | First follow-up (day 14) | 16.5 units on a scale | Standard Deviation 6.3 |
| Assessment Only | Moral Injury Events Scale (MIES) | Second follow-up (day 30) | 16.5 units on a scale | Standard Deviation 6.9 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Video-based Intervention | Patient Health Questionnaire-9 (PHQ-9) | Baseline (day 1) | 7.9 units on a scale | Standard Deviation 6.6 |
| Video-based Intervention | Patient Health Questionnaire-9 (PHQ-9) | First follow-up (day 14) | 7.4 units on a scale | Standard Deviation 6.7 |
| Video-based Intervention | Patient Health Questionnaire-9 (PHQ-9) | Second follow-up (day 30) | 7.0 units on a scale | Standard Deviation 6.2 |
| Assessment Only | Patient Health Questionnaire-9 (PHQ-9) | Baseline (day 1) | 6.6 units on a scale | Standard Deviation 5.6 |
| Assessment Only | Patient Health Questionnaire-9 (PHQ-9) | First follow-up (day 14) | 6.0 units on a scale | Standard Deviation 5.7 |
| Assessment Only | Patient Health Questionnaire-9 (PHQ-9) | Second follow-up (day 30) | 5.4 units on a scale | Standard Deviation 5.7 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Video-based Intervention | Primary Care Posttraumatic Stress Disorder (PC-PTSD) Screen | Baseline (day 1) | 1.9 units on a scale | Standard Deviation 1.6 |
| Video-based Intervention | Primary Care Posttraumatic Stress Disorder (PC-PTSD) Screen | First follow-up (day 14) | 1.8 units on a scale | Standard Deviation 1.6 |
| Video-based Intervention | Primary Care Posttraumatic Stress Disorder (PC-PTSD) Screen | Second follow-up (day 30) | 1.7 units on a scale | Standard Deviation 1.7 |
| Assessment Only | Primary Care Posttraumatic Stress Disorder (PC-PTSD) Screen | Baseline (day 1) | 1.8 units on a scale | Standard Deviation 1.7 |
| Assessment Only | Primary Care Posttraumatic Stress Disorder (PC-PTSD) Screen | First follow-up (day 14) | 1.2 units on a scale | Standard Deviation 1.5 |
| Assessment Only | Primary Care Posttraumatic Stress Disorder (PC-PTSD) Screen | Second follow-up (day 30) | 1.4 units on a scale | Standard Deviation 1.6 |