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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04646642
Other study ID # FWH20200203E
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 14, 2020
Est. completion date February 1, 2021

Study information

Verified date April 2021
Source David Grant U.S. Air Force Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date February 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States David Grant Medical Center (DGMC) Travis Air Force Base California

Sponsors (1)

Lead Sponsor Collaborator
David Grant U.S. Air Force Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (29)

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* Note: There are 29 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Positive Patient Health Questionnaire-2 (PHQ-2) 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. 1-2 months
Primary Positive PHQ-2 + High risk COVID physical condition 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. 1-2 months
Primary Positive PHQ-2 + pre-existing mental health conditions 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. 1-2 months
Primary Positive Generalized Anxiety Disorder-2 (GAD-2) 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. 1-2 months
Primary Positive GAD-2 + High risk COVID physical condition 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. 1-2 months
Primary Positive GAD-2 + pre-existing mental health conditions 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. 1-2 months
Primary Positive Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI-A) 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. 1-2 months
Primary Positive PSQI-A + High risk COVID physical condition 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. 1-2 months
Primary Positive PSQI-A + pre-existing mental health conditions 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. 1-2 months
Primary Deployer Identified COVID-19 Stressors 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. 1-2 months
Primary Positive Brief Coping Orientation to Problems Experienced (Brief COPE) 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 1-2 months
Primary Negative Brief Coping Orientation to Problems Experienced (Brief COPE) 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 1-2 months
Primary COVID-19 Coping Strategy and Resource Inventory 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 1-2 months
Primary Demographic questionnaire 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. 1-2 months
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