Psychological Health, Coping Strategies and Preferences of Military COVID-19 Deployers

• ClinicalTrials.gov Identifier: NCT04646642
• Recruitment Status: Completed
• First Posted: November 30, 2020
• Last Update Posted: April 2, 2021
• Sponsor: David Grant U.S. Air Force Medical Center
• Information provided by (Responsible Party): Amanda Fox, David Grant U.S. Air Force Medical Center

Study Description

Brief Summary:

The proposed research study aims to better understand COVID deployer needs. The study, informally referred to as Project COPE, asks David Grant U.S. Air Force Medical Center (DGMC) members who deployed in support of COVID-19 operations to complete a needs assessment questionnaire. The purpose of this study is to understand the stressful experiences of our COVID Theater Hospital (CTH) deployers, the typical coping strategies used and recommended preferences for support so that the investigators can provide the best evidence-based resources for post-deployment and to aid future CTH deployers.

Condition or disease
Coping Skills; Healthcare Workers; Covid19

Detailed Description:

Objective: This study focuses on exploring David Grant USAF Medical deployer psychological status and the coping skills utilized during deployment as well as a needs assessment of preferred coping resources.

Specific Aims:

• Aim 1: Describe the post-deployment state of psychological health for COVID-19 Theater Hospital (CTH) deployers
• Aim 2: Identify the deployer identified COVID-19-related stressors reported post deployment
• Aim 3: Identify coping and cognition regulating strategies used by deployers in response to COVID-19 deployment stressors
• Aim 4: Identify deployer coping resource preferences for future deployment support packages

Methods: Recruitment of eligible participants will include email invitations, packets with pre-printed needs assessment folders placed next to posters, flyers, and briefing at DGMC events. Eligible participants (n=160) returning from COVID Theater Hospital (CTH) deployment (est. Oct 2020) will receive a needs assessment that includes:

1. Patient Health Questionnaire-2 (PHQ-2) is a 2-item screening tool for depression that uses the first two items from the 9-item Patient Health Questionnaire. Respondents are asked to report symptom frequency ranging from 0 (not at all) to 3 (nearly every day) for the following questions, "Over the last 2 weeks, how often have you been bothered by any of the following problems: 1) little interest or pleasure in doing things, and 2) feeling down, depressed, or hopeless?" Total scores exceeding 2 suggest a positive depression screening. Participants who screen positive should be evaluated with the PHQ-9 to identify diagnostic depressive disorder criteria. It is important to note that all CTH deployers will complete a PHQ-9 during their post-deployment health assessment. Construct and criterion validity were established in a sample of 6000 primary care and obstetrics patients where the PHQ-2 score had a sensitivity of ≥ 83% and a specificity of 92% for major depression. A PHQ-2 score of 3 was identified as the optimal cut point as indicated by likelihood ratio and receiver operator characteristic analysis (Kroenke, Spitzer, & Williams, 2003). This tool provides a brief, practical, valid, and reliable screening instrument.
2. Generalized Anxiety Disorder-2 (GAD-2) is a 2-item screening tool for Generalized Anxiety Disorder. The tool asks respondents to report symptom frequency ranging from 0 (not at all) to 3 (nearly every day) for the following two questions: "Over the last 2 weeks, how often have you been bothered by the following problems:1) Feeling nervous, anxious or on edge, and, 2) Not being able to stop or control worrying?" A total score of 3 points or greater identifies a positive screen and warrants further diagnostic evaluation with the GAD-7 for Generalized Anxiety Disorder criteria. It is important to note that all CTH deployers will complete a GAD-7 during their post-deployment health assessment. The GAD-2 was validated in a randomized sample of 965 primary care patients demonstrating a sensitivity of 86% and specificity of 83% with an 0.908 area under the curve (95% CI) for a diagnosis of Generalized Anxiety Disorder (Kroenke, Spitzer, Williams, Monahan, & Lö, 2007). This tool provides a brief, practical, valid, and reliable screening instrument.
3. Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI-A) is a 7-item questionnaire used to examine disruptive nocturnal behaviors (hot flashes, nervousness, traumatic memories, anxiety, bad dreams, terror/screaming, acting out dreams) common in adults with PTSD. Response items are endorsed for frequency (not during the past month, less than once a week, once or twice a week, three or more times a week). Good internal consistency and convergent validity were demonstrated with anxiety, depression, sleep quality, combat exposure, and PTSD symptoms. The PSQI-A had a Cronbach's #= 0.72 and an average inter-item correlation r = 0.44 (range 0.27-0.57) with the PSQI-A total score. Area under the curve was 0.81, for a cut point ≥ 4 resulting in 71% sensitivity, 82% specificity, and 60% positive and 83% negative predictive value for clinically diagnostic PTSD purposes and a 74% correct classification (Insana, Hall, Buysse, & Germain, 2013). Sleep disturbances reflect a core dysfunction underlying PTSD. The PSQI-A is a valid instrument for PTSD applicable to both clinical and research settings.It is important to note that all CTH deployers will complete a Post-Traumatic Stress Disorder screening during the post-deployment health assessment.
4. Deployer Identified COVID-19 Stressors. Currently there are no valid and reliable instruments specific to COVID-19 distress. Given this is a novel pandemic, investigators requested deployers to list top 3 stressors experienced during deployment. Participants rated listed items as: 1-no distress, 2-mildy distressing, 3-distressing 4-very distressing, and 5-extremely distressing.
5. The Brief Coping Orientation to Problems Experienced (Brief COPE) is a 28-item multidimensional measure of 14 strategies (humor, positive reframing, acceptance, active coping, planning, behavioral disengagement, self-distraction, substance use, denial, self-blame, venting, emotional support, instrumental support, religion) used for coping or regulating cognitions in response to stressors. This abbreviated inventory (based on the complete 60-item COPE Inventory) is comprised of items that assess the frequency with which a person uses different coping strategies rated on a scale from 0-"I haven't been doing this at all" to 4-"I've been doing this a lot." (Amoyal et al., 2011). Investigators eliminated two items that deal with drugs and alcohol to maintain the eligibility of exempt protocol status.
6. COVID-19 Coping Strategy and Resource Inventory is an 18-item resource inventory developed by the DGMC research team to assess preferred strategic resources to manage COVID-19-related stressors. The inventory includes 5 categories of coping resources: 1) interactive [exercise, spiritual, social, mental health visit], 2) self-help videos/webinars, 3) mobile applications, 4) electronic toolkits, 5) podcasts.
7. Demographic questionnaire includes 10 questions regarding individual deployer sex, COVID-19 risk status, mental health risk status, COVID-19 risk status of any family members at home, years of experience in current occupation and specific healthcare role, typical work setting at DGMC, any recent deployments

Study participation will occur through a single collection of anonymous self-report measures using paper pencil which will be completed with an anticipated time burden of under 15 minutes (based on preliminary practice trials) and returned to locked drop-boxes strategically placed on four inpatient/outpatient areas.

Results: Findings will inform the development of a DGMC COVID-19 healthcare worker psychological coping and well-being toolkit.

Study Design

• Study Type: Observational
• Actual Enrollment: 21 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Psychological Health, Coping Strategies and Preferences of David Grant USAF Medical Center COVID-19 Deployers: A Critical Needs Assessment
• Actual Study Start Date: December 14, 2020
• Actual Primary Completion Date: February 1, 2021
• Actual Study Completion Date: February 1, 2021

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Positive Patient Health Questionnaire-2 (PHQ-2) [ Time Frame: 1-2 months ]
   Describe the frequencies of positive screen for depression based on total score >/= 3 on PHQ-2. The PHQ-2 is a 2-item screening tool for depression that uses first 2 items from PHQ-9. Scale 0 (not at all) to 3 (nearly every day), 0 is better and 3 worse. Total scores exceeding 2 suggest a positive depression screening. This tool provides a brief, practical, valid, and reliable screening instrument.
2. Positive PHQ-2 + High risk COVID physical condition [ Time Frame: 1-2 months ]
   Describe the frequencies and percentages of positive screened PHQ-2 individuals who also responded YES for self-reported high-risk COVID physical conditions on demographic questionnaire. The PHQ-2 is a 2-item screening tool for depression that uses first 2 items from PHQ-9. Scale 0 (not at all) to 3 (nearly every day), 0 is better and 3 worse. Total scores exceeding 2 suggest a positive depression screening. This tool provides a brief, practical, valid, and reliable screening instrument. The demographic questionnaire consist of 10 questions, one is COVID-19 risk status. A YES response to "Do you have any underlying physical health conditions that place you in a high-risk COVID category would be included in this measure.
3. Positive PHQ-2 + pre-existing mental health conditions [ Time Frame: 1-2 months ]
   Describe the frequencies and percentages of positive screened PHQ-2 individuals who also responded YES for self-reported pre-existing mental health conditions on demographic questionnaire. The PHQ-2 is a 2-item screening tool for depression that uses first 2 items from PHQ-9. Scale 0 (not at all) to 3 (nearly every day), 0 is better and 3 worse. Total scores exceeding 2 suggest a positive depression screening. This tool provides a brief, practical, valid, and reliable screening instrument. The demographic questionnaire consist of 10 questions, one is mental health risk status. A YES response to "Do you have any underlying mental health concerns (anxiety, depression, difficulty sleeping, etc.), or have you visited a mental health professional in the past 6 months?" would be included in this measure.
4. Positive Generalized Anxiety Disorder-2 (GAD-2) [ Time Frame: 1-2 months ]
   Describe the frequencies of positive screen for depression based on total score >/= 3 on GAD-2. The GAD-2 is a 2-item screening tool for Generalized Anxiety Disorder. Scale 0 (not at all) to 3 (nearly every day), 0 is better and 3 worse. A total score of 3 points or greater identifies a positive screen and warrants further diagnostic evaluation with GAD-7 for Generalized Anxiety Disorder criteria. This tool provides a brief, practical, valid, and reliable screening instrument.
5. Positive GAD-2 + High risk COVID physical condition [ Time Frame: 1-2 months ]
   Describe the frequencies and percentages of positive screened GAD-2 individuals who also responded YES for self-reported high-risk COVID physical conditions on demographic questionnaire. The GAD-2 is a 2-item screening tool for Generalized Anxiety Disorder. Scale 0 (not at all) to 3 (nearly every day), 0 is better and 3 worse. A total score of 3 points or greater identifies a positive screen and warrants further diagnostic evaluation with GAD-7 for Generalized Anxiety Disorder criteria. This tool provides a brief, practical, valid, and reliable screening instrument. The demographic questionnaire consist of 10 questions, one is COVID-19 risk status. A YES response to "Do you have any underlying physical health conditions that place you in a high-risk COVID category would be included in this measure.
6. Positive GAD-2 + pre-existing mental health conditions [ Time Frame: 1-2 months ]
   Describe the frequencies and percentages of positive screened GAD-2 individuals who also responded YES for self-reported pre-existing mental health conditions on demographic questionnaire. The GAD-2 is a 2-item screening tool for Generalized Anxiety Disorder. Scale 0 (not at all) to 3 (nearly every day), 0 is better and 3 worse. A total score of 3 points or greater identifies a positive screen and warrants further diagnostic evaluation with GAD-7 for Generalized Anxiety Disorder criteria. This tool provides a brief, practical, valid, and reliable screening instrument. The demographic questionnaire consist of 10 questions, one is mental health risk status. A YES response to "Do you have any underlying mental health concerns (anxiety, depression, difficulty sleeping, etc.), or have you visited a mental health professional in the past 6 months?" would be included in this measure.
7. Positive Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI-A) [ Time Frame: 1-2 months ]
   Describe the frequencies of positive screen for depression based on total score > 4 on PSQI-A. The PSQI-A is a 7-item questionnaire used to examine disruptive nocturnal behaviors common in adults with PTSD. Response items are endorsed for frequency. Scale 0 (not during the past month) to 4 (3 or more times a week), 0 is better and 4 worse. The PSQI-A is a valid instrument for PTSD applicable to both clinical and research settings.
8. Positive PSQI-A + High risk COVID physical condition [ Time Frame: 1-2 months ]
   Describe the frequencies and percentages of positive screened PSQI-A individuals who also responded YES for self-reported high-risk COVID physical conditions on demographic questionnaire. The PSQI-A is a 7-item questionnaire used to examine disruptive nocturnal behaviors common in adults with PTSD. Response items are endorsed for frequency. Scale 0 (not during the past month) to 4 (3 or more times a week), 0 is better and 4 worse. The PSQI-A is a valid instrument for PTSD applicable to both clinical and research settings. The demographic questionnaire consist of 10 questions, one is COVID-19 risk status. A YES response to "Do you have any underlying physical health conditions that place you in a high-risk COVID category would be included in this measure.
9. Positive PSQI-A + pre-existing mental health conditions [ Time Frame: 1-2 months ]
   Describe the frequencies and percentages of positive screened PSQI-A individuals who also responded YES for self-reported pre-existing mental health conditions on demographic questionnaire. The PSQI-A is a 7-item questionnaire used to examine disruptive nocturnal behaviors common in adults with PTSD by frequency. Scale 0 (not during the past month) to 4 (3 or more times a week), 0 is better and 4 worse. The demographic questionnaire consist of 10 questions, one is mental health risk status. A YES response to "Do you have any underlying mental health concerns (anxiety, depression, difficulty sleeping, etc.), or have you visited a mental health professional in the past 6 months?" would be included in this measure.
10. Deployer Identified COVID-19 Stressors [ Time Frame: 1-2 months ]
    Describe the severity of deployer identified COVID-19 stressors. A tool that requests deployers to list top 3 stressors experienced during deployment. Participants rated listed items as: 1-no distress, 2-mildly distressing, 3-distressing, 4- very distressing, and 5-extremely distressing. Scale 0 (no distress) to 5 (extremely distressing), 0 is better and 5 worse.
11. Positive Brief Coping Orientation to Problems Experienced (Brief COPE) [ Time Frame: 1-2 months ]
    Describe the prevalence of positive coping strategies by percentage based on scores >/= 3 (3-I've been doing this medium amount; 4-I've been doing this a lot) for items targeting: humor, positive reframing, acceptance, active coping, planning, emotional support, instrumental support, religion. The Brief COPE is a 28-item multidimensional measure of 14 strategies (those above, as well as, behavioral disengagement, self-distraction, substance use, denial, self-blame, venting) used for coping or regulating cognitions in response to stressors. This abbreviated inventory (based on the complete 60-item COPE Inventory) is comprised of items that assess the frequency with which a person uses different coping strategies rated on a scale from 0-"I haven't been doing this at all" to 4-"I've been doing this a lot." (Amoyal et al., 2011). 4 is better and 0 worse. Two items related to drugs and alcohol were eliminated to maintain the eligibility of exempt protocol status
12. Negative Brief Coping Orientation to Problems Experienced (Brief COPE) [ Time Frame: 1-2 months ]
    Describe the prevalence of negative coping strategies by percentage based on scores >/= 3 (3-I've been doing this medium amount; 4-I've been doing this a lot) for items targeting: behavioral disengagement, self-distraction, substance use, denial, self-blame, venting. The Brief COPE is a 28-item multidimensional measure of 14 strategies (those above, as well as, humor, positive reframing, acceptance, active coping, planning, emotional support, instrumental support, religion) used for coping or regulating cognitions in response to stressors. This abbreviated inventory (based on the complete 60-item COPE Inventory) is comprised of items that assess the frequency with which a person uses different coping strategies rated on a scale from 0-"I haven't been doing this at all" to 4-"I've been doing this a lot." (Amoyal et al., 2011). 0 is better and 4 worse. Two items related to drugs and alcohol were eliminated to maintain the eligibility of exempt protocol status
13. COVID-19 Coping Strategy and Resource Inventory [ Time Frame: 1-2 months ]
    Describe the frequency of preferred coping resources using the COVID-19 Coping Strategy and Resource Inventory. This is an 18-item resource inventory developed by our DGMC research team to assess preferred strategic resources to manage COVID-19-related stressors. The inventory includes 5 categories of coping resources: 1) interactive [exercise, spiritual, social, mental health visit], 2) self-help videos/webinars, 3) mobile applications, 4) electronic toolkits, 5) podcasts
14. Demographic questionnaire [ Time Frame: 1-2 months ]
    Describe the demographic characteristics of the respondents using the demographic questionnaire. These are 10 questions regarding individual deployer sex, COVID-19 risk status, mental health risk status, COVID-19 risk status of any family members at home, years of experience in current occupation and specific healthcare role, typical work setting at DGMC, any recent deployments.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Active duty healthcare workers assigned to David Grant U.S. Air Force Medical Center (DGMC) who deployed in July 2020, under the command of Col Justin Nast and the COVID Theater Hospital (CTH), in support of 8 civilian California hospitals.

Criteria

Inclusion Criteria:

• The eligible participant group includes David Grant United States Air Force (USAF) Medical Center Active Duty personnel:

  1. Medical technicians (4N)
  2. Liaison officers (LNO's)
  3. Nurses
  4. Physician assistants
  5. Advanced practice nurses
  6. Respiratory therapists
  7. Psychologists
  8. Social workers
  9. Chaplains
  10. Physicians

• Deployed in July 2020, under the command of Col Justin Nast and the COVID Theater Hospital (CTH) in support of the following civilian facilities:

  1. Adventist Health Lodi Memorial Hospital, Lodi, CA
  2. Eisenhower Medical Center, Rancho Mirage, CA
  3. Community Regional Medical Center, Fresno, CA
  4. Kaweah Delta Health Care, Visalia, CA
  5. Adventist Health Dameron Hospital, Stockton, CA
  6. Adventist Health Hanford, Hanford, CA
  7. Los Angeles County-University of Southern California (LA County-USC) Medical Center, Los Angeles, CA
  8. Harbor-University of California Los Angeles (UCLA) Medical Center, Torrance, CA

Exclusion Criteria:

• Activated guard, reserve, or civilian healthcare deployers in support of COVID-19
• Active duty healthcare deployers from MTF's other than DGMC in support of California (CA) civilian hospitals other than the eight facilities named in the above inclusion criteria.

Contacts and Locations

Locations

United States, California

David Grant Medical Center (DGMC)

Travis Air Force Base, California, United States, 94535

Sponsors and Collaborators

David Grant U.S. Air Force Medical Center

Investigators

• Principal Investigator: Amanda A Fox, MSN; David Grant Medical Center, Travis Air Force Base
• Principal Investigator: Laurie A Migliore, PhD; David Grant Medical Center, Travis Air Force Base

More Information

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• Responsible Party: Amanda Fox, Clinical Inquiry in Nursing Readiness Fellow, David Grant U.S. Air Force Medical Center
• ClinicalTrials.gov Identifier: NCT04646642
• Other Study ID Numbers: FWH20200203E
• First Posted: November 30, 2020
• Last Update Posted: April 2, 2021
• Last Verified: April 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases