Psychological Health, Coping Strategies and Preferences of Military COVID-19 Deployers
NCT ID: NCT04646642
Last Updated: 2021-04-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
21 participants
Study Classification
OBSERVATIONAL
Study Start Date
2020-12-14
Study Completion Date
2021-02-01
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Coping Skills
Healthcare Workers
Covid19
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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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
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
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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David Grant U.S. Air Force Medical Center
FED
Sponsor Role
lead
Responsible Party
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Amanda Fox
Clinical Inquiry in Nursing Readiness Fellow
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Amanda A Fox, MSN
Role: PRINCIPAL_INVESTIGATOR
David Grant Medical Center, Travis Air Force Base
Laurie A Migliore, PhD
Role: PRINCIPAL_INVESTIGATOR
David Grant Medical Center, Travis Air Force Base
Locations
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David Grant Medical Center (DGMC)
Travis Air Force Base, California, United States
Site Status
Countries
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United States
References
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Shechter A, Diaz F, Moise N, Anstey DE, Ye S, Agarwal S, Birk JL, Brodie D, Cannone DE, Chang B, Claassen J, Cornelius T, Derby L, Dong M, Givens RC, Hochman B, Homma S, Kronish IM, Lee SAJ, Manzano W, Mayer LES, McMurry CL, Moitra V, Pham P, Rabbani L, Rivera RR, Schwartz A, Schwartz JE, Shapiro PA, Shaw K, Sullivan AM, Vose C, Wasson L, Edmondson D, Abdalla M. Psychological distress, coping behaviors, and preferences for support among New York healthcare workers during the COVID-19 pandemic. Gen Hosp Psychiatry. 2020 Sep-Oct;66:1-8. doi: 10.1016/j.genhosppsych.2020.06.007. Epub 2020 Jun 16.
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Other Identifiers
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FWH20200203E
Identifier Type: -
Identifier Source: org_study_id
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