Coping SkillsNCT04646642

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

An observational study of Coping Skills and Healthcare Workers, run by David Grant U.S. Air Force Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Coping Skills, Healthcare Workers, Covid19
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 14 Dec 2020to 1 Feb 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

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.

Who may be able to join

The eligible participant group includes David Grant United States Air Force (USAF) Medical Center Active Duty personnel:
Medical technicians (4N)
Liaison officers (LNO's)
Nurses
Physician assistants
Advanced practice nurses

Show all 20Show fewer

Respiratory therapists
Psychologists
Social workers
Chaplains
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:
Adventist Health Lodi Memorial Hospital, Lodi, CA
Eisenhower Medical Center, Rancho Mirage, CA
Community Regional Medical Center, Fresno, CA
Kaweah Delta Health Care, Visalia, CA
Adventist Health Dameron Hospital, Stockton, CA
Adventist Health Hanford, Hanford, CA
Los Angeles County-University of Southern California (LA County-USC) Medical Center, Los Angeles, CA
Harbor-University of California Los Angeles (UCLA) Medical Center, Torrance, CA

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

David Grant Medical Center (DGMC)
Travis Air Force Base, California, 94535

Other trials in United States

About this study

Official title: Psychological Health, Coping Strategies and Preferences of David Grant USAF Medical Center COVID-19 Deployers: A Critical Needs Assessment

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.

Read the 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:

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.
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.
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.
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.
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.
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.
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: Coping Skills, Healthcare Workers, Covid19
Medical subject headings: COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1-2 months
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.
Measured: 1-2 months
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.
Measured: 1-2 months
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.
Measured: 1-2 months
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.
Measured: 1-2 months
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.
Measured: 1-2 months
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.
Measured: 1-2 months
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.
Measured: 1-2 months
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.
Measured: 1-2 months
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.
Measured: 1-2 months
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
Measured: 1-2 months
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
Measured: 1-2 months
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
Measured: 1-2 months
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.
Measured: 1-2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 20201 Feb 2021

First posted30 Nov 2020
Study start14 Dec 2020
Primary completion1 Feb 2021
Study completion1 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Coping SkillsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04646642
Sponsor's protocol ID: FWH20200203E
Status last verified: Apr 2021
First submitted: 25 Nov 2020
Last updated: 2 Apr 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Amoyal NR, Mason ST, Gould NF, Corry N, Mahfouz S, Barkey A, Fauerbach JA. Measuring coping behavior in patients with major burn injuries: a psychometric evaluation of the BCOPE. J Burn Care Res. 2011 May-Jun;32(3):392-8. doi: 10.1097/BCR.0b013e318217f97a.
PubMed 21562462
Braquehais MD, Vargas-Caceres S, Gomez-Duran E, Nieva G, Valero S, Casas M, Bruguera E. The impact of the COVID-19 pandemic on the mental health of healthcare professionals. QJM. 2020 Jun 22:hcaa207. doi: 10.1093/qjmed/hcaa207. Online ahead of print.
PubMed 32569374
Cacioppo JT, Reis HT, Zautra AJ. Social resilience: the value of social fitness with an application to the military. Am Psychol. 2011 Jan;66(1):43-51. doi: 10.1037/a0021419.
PubMed 21219047
Cullen W, Gulati G, Kelly BD. Mental health in the COVID-19 pandemic. QJM. 2020 May 1;113(5):311-312. doi: 10.1093/qjmed/hcaa110. No abstract available.
PubMed 32227218
The Depressed Project: Living Systematic Review of Mental Health in COVID-19 Retrieved August 27, 2020, https://www.depressd.ca/covid-19-mental-health
Folkman S. Personal control and stress and coping processes: a theoretical analysis. J Pers Soc Psychol. 1984 Apr;46(4):839-52. doi: 10.1037//0022-3514.46.4.839.
PubMed 6737195
Greenberg N. Mental health of health-care workers in the COVID-19 era. Nat Rev Nephrol. 2020 Aug;16(8):425-426. doi: 10.1038/s41581-020-0314-5.
PubMed 32561871
Hawkley LC, Thisted RA, Masi CM, Cacioppo JT. Loneliness predicts increased blood pressure: 5-year cross-lagged analyses in middle-aged and older adults. Psychol Aging. 2010 Mar;25(1):132-41. doi: 10.1037/a0017805.
PubMed 20230134
Hawkley L, Preacher K, Cacioppo J. As We Said, Loneliness (Not Living Alone) Explains Individual Differences in Sleep Quality: Reply. Health Psychol. 2011 Mar;30(2):136. doi: 10.1037/a0022366. No abstract available.
PubMed 25067871
Hobfoll, S. E. (1998). The Plenum series on stress and coping.Stress, culture, and community: The psychology and philosophy of stress. Plenum Press. https://doi.org/10.1007/978-1-4899- 0115-6
Holmes EA, O'Connor RC, Perry VH, Tracey I, Wessely S, Arseneault L, Ballard C, Christensen H, Cohen Silver R, Everall I, Ford T, John A, Kabir T, King K, Madan I, Michie S, Przybylski AK, Shafran R, Sweeney A, Worthman CM, Yardley L, Cowan K, Cope C, Hotopf M, Bullmore E. Multidisciplinary research priorities for the COVID-19 pandemic: a call for action for mental health science. Lancet Psychiatry. 2020 Jun;7(6):547-560. doi: 10.1016/S2215-0366(20)30168-1. Epub 2020 Apr 15.
PubMed 32304649
Hulley, S. B., Cummings, S. R., Browner, W. S., Grady, D., Hearst, N., & Newman, T. B. (2007). Designing clinical research. Philadelphia.
Insana SP, Hall M, Buysse DJ, Germain A. Validation of the Pittsburgh Sleep Quality Index Addendum for posttraumatic stress disorder (PSQI-A) in U.S. male military veterans. J Trauma Stress. 2013 Apr;26(2):192-200. doi: 10.1002/jts.21793. Epub 2013 Mar 19.
PubMed 23512653
Jansoon, M., & Rello, J. (2020). Mental Health in Healthcare Workers and the Covid-19 Pandemic Era: Novel Challenge for Critical Care Abstract. Journal of Intensive and Critical Care, 6(26), 1-3. https://doi.org/10.36648/2471-8505.6.2.6
Lazarus, R. S., & Folkman, S. (1984). Stress, appraisal, and coping. Springer publishing company.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Psychological Health, Coping Strategies and Preferences of David Grant USAF Medical Center COVID-19 Deployers: A Critical Needs Assessment
ClinicalTrials.gov ID: NCT04646642
Acronym / sponsor ID: FWH20200203E
Conditions: Coping Skills, Healthcare Workers, Covid19
Study type: Observational
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: David Grant U.S. Air Force Medical CenterUS federal agency
Study start: 14 Dec 2020 (actual)
Primary completion: 1 Feb 2021 (actual)
Study completion: 1 Feb 2021 (actual)
First posted: 30 Nov 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

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.
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.
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.
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.
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.
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.
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

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

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (20 listed)

The eligible participant group includes David Grant United States Air Force (USAF) Medical Center Active Duty personnel:
Deployed in July 2020, under the command of Col Justin Nast and the COVID Theater Hospital (CTH) in support of the following civilian facilities:

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
Background: PubMed 21562462Amoyal NR, Mason ST, Gould NF, Corry N, Mahfouz S, Barkey A, Fauerbach JA. Measuring coping behavior in patients with major burn injuries: a psychometric evaluation of the BCOPE. J Burn Care Res. 2011 May-Jun;32(3):392-8. doi: 10.1097/BCR.0b013e318217f97a.
Background: PubMed 32569374Braquehais MD, Vargas-Caceres S, Gomez-Duran E, Nieva G, Valero S, Casas M, Bruguera E. The impact of the COVID-19 pandemic on the mental health of healthcare professionals. QJM. 2020 Jun 22:hcaa207. doi: 10.1093/qjmed/hcaa207. Online ahead of print.
Background: PubMed 21219047Cacioppo JT, Reis HT, Zautra AJ. Social resilience: the value of social fitness with an application to the military. Am Psychol. 2011 Jan;66(1):43-51. doi: 10.1037/a0021419.
Background: PubMed 32227218Cullen W, Gulati G, Kelly BD. Mental health in the COVID-19 pandemic. QJM. 2020 May 1;113(5):311-312. doi: 10.1093/qjmed/hcaa110. No abstract available.
BackgroundThe Depressed Project: Living Systematic Review of Mental Health in COVID-19 Retrieved August 27, 2020, https://www.depressd.ca/covid-19-mental-health
Background: PubMed 6737195Folkman S. Personal control and stress and coping processes: a theoretical analysis. J Pers Soc Psychol. 1984 Apr;46(4):839-52. doi: 10.1037//0022-3514.46.4.839.
Background: PubMed 32561871Greenberg N. Mental health of health-care workers in the COVID-19 era. Nat Rev Nephrol. 2020 Aug;16(8):425-426. doi: 10.1038/s41581-020-0314-5.
Background: PubMed 20230134Hawkley LC, Thisted RA, Masi CM, Cacioppo JT. Loneliness predicts increased blood pressure: 5-year cross-lagged analyses in middle-aged and older adults. Psychol Aging. 2010 Mar;25(1):132-41. doi: 10.1037/a0017805.
Background: PubMed 25067871Hawkley L, Preacher K, Cacioppo J. As We Said, Loneliness (Not Living Alone) Explains Individual Differences in Sleep Quality: Reply. Health Psychol. 2011 Mar;30(2):136. doi: 10.1037/a0022366. No abstract available.
BackgroundHobfoll, S. E. (1998). The Plenum series on stress and coping.Stress, culture, and community: The psychology and philosophy of stress. Plenum Press. https://doi.org/10.1007/978-1-4899- 0115-6
Background: PubMed 32304649Holmes EA, O'Connor RC, Perry VH, Tracey I, Wessely S, Arseneault L, Ballard C, Christensen H, Cohen Silver R, Everall I, Ford T, John A, Kabir T, King K, Madan I, Michie S, Przybylski AK, Shafran R, Sweeney A, Worthman CM, Yardley L, Cowan K, Cope C, Hotopf M, Bullmore E. Multidisciplinary research priorities for the COVID-19 pandemic: a call for action for mental health science. Lancet Psychiatry. 2020 Jun;7(6):547-560. doi: 10.1016/S2215-0366(20)30168-1. Epub 2020 Apr 15.
BackgroundHulley, S. B., Cummings, S. R., Browner, W. S., Grady, D., Hearst, N., & Newman, T. B. (2007). Designing clinical research. Philadelphia.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amanda A Fox, MSN principal investigator

David Grant Medical Center, Travis Air Force Base

Laurie A Migliore, PhD principal investigator

David Grant Medical Center, Travis Air Force Base

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coping Skills and Healthcare Workers, run by David Grant U.S. Air Force Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive Patient Health Questionnaire-2 (PHQ-2) (time frame: 1-2 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04646642, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.