Covid19 Clinical Trial
Official title:
Psychological Health, Coping Strategies and Preferences of David Grant USAF Medical Center COVID-19 Deployers: A Critical Needs Assessment
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | David Grant Medical Center (DGMC) | Travis Air Force Base | California |
Lead Sponsor | Collaborator |
---|---|
David Grant U.S. Air Force Medical Center |
United States,
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. — View Citation
Braquehais MD, Vargas-Cáceres S, Gómez-Durán 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. pii: hcaa207. doi: 10.1093/qjmed/hcaa207. [Epub ahead of print] — View Citation
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. — View Citation
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. — View Citation
Folkman S. Personal control and stress and coping processes: a theoretical analysis. J Pers Soc Psychol. 1984 Apr;46(4):839-52. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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
Kroenke K, Spitzer RL, Williams JB, Monahan PO, Löwe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. — View Citation
Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. — View Citation
Kurina LM, Knutson KL, Hawkley LC, Cacioppo JT, Lauderdale DS, Ober C. Loneliness is associated with sleep fragmentation in a communal society. Sleep. 2011 Nov 1;34(11):1519-26. doi: 10.5665/sleep.1390. — View Citation
Lazarus, R. S., & Folkman, S. (1984). Stress, appraisal, and coping. Springer publishing company.
Muller AE, Hafstad EV, Himmels JPW, Smedslund G, Flottorp S, Stensland SØ, Stroobants S, Van de Velde S, Vist GE. The mental health impact of the covid-19 pandemic on healthcare workers, and interventions to help them: A rapid systematic review. Psychiatry Res. 2020 Nov;293:113441. doi: 10.1016/j.psychres.2020.113441. Epub 2020 Sep 1. — View Citation
Pfefferbaum, B., & North, C. S. (2020). Mental health and the COVID-19 pandemic. The New England Journal of Medicine, 383(6), 508-510. https://doi.org/10.1056/NEJMp2013466
Poonian J, Walsham N, Kilner T, Bradbury E, Brooks K, West E. Managing healthcare worker well-being in an Australian emergency department during the COVID-19 pandemic. Emerg Med Australas. 2020 Aug;32(4):700-702. doi: 10.1111/1742-6723.13547. Epub 2020 Jun 25. — View Citation
Rajkumar RP. COVID-19 and mental health: A review of the existing literature. Asian J Psychiatr. 2020 Aug;52:102066. doi: 10.1016/j.ajp.2020.102066. Epub 2020 Apr 10. — View Citation
Rossi R, Socci V, Pacitti F, Di Lorenzo G, Di Marco A, Siracusano A, Rossi A. Mental Health Outcomes Among Frontline and Second-Line Health Care Workers During the Coronavirus Disease 2019 (COVID-19) Pandemic in Italy. JAMA Netw Open. 2020 May 1;3(5):e2010185. doi: 10.1001/jamanetworkopen.2020.10185. — View Citation
Shah K, Kamrai D, Mekala H, Mann B, Desai K, Patel RS. Focus on Mental Health During the Coronavirus (COVID-19) Pandemic: Applying Learnings from the Past Outbreaks. Cureus. 2020 Mar 25;12(3):e7405. doi: 10.7759/cureus.7405. Review. — View Citation
Shaukat N, Ali DM, Razzak J. Physical and mental health impacts of COVID-19 on healthcare workers: a scoping review. Int J Emerg Med. 2020 Jul 20;13(1):40. doi: 10.1186/s12245-020-00299-5. Review. — View Citation
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. — View Citation
Skinner EA, Zimmer-Gembeck MJ. The development of coping. Annu Rev Psychol. 2007;58:119-44. — View Citation
Spoorthy MS, Pratapa SK, Mahant S. Mental health problems faced by healthcare workers due to the COVID-19 pandemic-A review. Asian J Psychiatr. 2020 Jun;51:102119. doi: 10.1016/j.ajp.2020.102119. Epub 2020 Apr 22. Review. — View Citation
The Depressed Project: Living Systematic Review of Mental Health in COVID-19 Retrieved August 27, 2020, https://www.depressd.ca/covid-19-mental-health
Worldometer. (n.d.). Coronavirus Cases. Retrieved August 22, 2020, https://www.worldometers.info /coronavirus/.
* Note: There are 29 references in all — Click here to view all references
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05047692 -
Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04395768 -
International ALLIANCE Study of Therapies to Prevent Progression of COVID-19
|
Phase 2 | |
Completed |
NCT04506268 -
COVID-19 SAFE Enrollment
|
N/A | |
Terminated |
NCT04555096 -
A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
|
Phase 2 | |
Completed |
NCT04508777 -
COVID SAFE: COVID-19 Screening Assessment for Exposure
|
||
Completed |
NCT04961541 -
Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04546737 -
Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients
|
N/A | |
Not yet recruiting |
NCT04543006 -
Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19
|
N/A | |
Terminated |
NCT04542993 -
Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy
|
Phase 2 | |
Terminated |
NCT04581915 -
PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19
|
Phase 2/Phase 3 | |
Completed |
NCT04494646 -
BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)
|
Phase 2 | |
Completed |
NCT04532294 -
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
|
Phase 1 | |
Completed |
NCT04387292 -
Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic
|
N/A | |
Completed |
NCT04537663 -
Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults
|
Phase 4 | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Not yet recruiting |
NCT04527211 -
Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel
|
Phase 3 | |
Completed |
NCT04979858 -
Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask
|
N/A | |
Not yet recruiting |
NCT05038449 -
Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19
|
N/A | |
Completed |
NCT04610502 -
Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients
|
Phase 2 | |
Active, not recruiting |
NCT06042855 -
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)
|
Phase 3 |