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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04395872
Other study ID # CR-20-062
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 28, 2020
Est. completion date December 31, 2020

Study information

Verified date May 2020
Source Daegu Catholic University Medical Center
Contact geunhui Won, M.D.
Phone +82-53-650-4780
Email guenheu@hanmail.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study, the content and results of the psychiatric consultation on patients in Corona Care Ward were verified retroactively, and the effects of COVID-19 patients' emotional state and psychological support and crisis intervention were assessed on their emotional state.

Patients who are admitted to the COVID-19 care unit of the Catholic University of Daegu Hospital are subject to consultation with the psychiatrist. By retrospectively reviewing the medical records of the request and the results of the subjects, We collected Socio-demographic information, medical severity (oxygen saturation, chest x-ray readings, medication being administered), clinical psychological scale (PHQ-9, GAD-7, PC-PTSD-5, AIS, P4, SF-36, SCL-90-R) This study evaluates whether there is a difference in psychological scale according to differences in socio-demographic status and medical severity, and compares psychological measures before and after referral to mental health medicine to evaluate the effectiveness of psychiatric counseling.


Description:

Patients and medical workers in the event of an pandemic infectious disease usually experience extreme fear, which requires quick and immediate management of mental health. In 2015, the risk of post-traumatic stress disorder in isolated MERS patients and medical staff was very high. Even 4 ~ 6 months after the quarantine was over, anxiety was still lingering in 3% percent of patients and anger in 6.4 % of patients. The negative emotions and stress experienced by the medical staff for MERS patients were characterized by such events as mistakes and delays caused by communication problems. Also, people who were not infected with MERS experienced anxiety at 7.6 percent and anger at 16.6 percent during the quarantine period.Therefore, the need for psychological support for infected patients, isolated people, medical staff and the general public had been proposed during these infectious disease fad periods since MERS. Since the recent spread of coronavirus infection-19 (COVID-19) that began in Wuhan, China in December 2019, thousands of confirmed and dozens of deaths have been reported in South Korea and the number is on the rise. Thus, quarantine measures are currently being taken in Korea to reduce and treat the spread of COVID-19. Thus, psychological support and crisis intervention are needed in the early stages of stressful times to reduce anxiety, depression and post-traumatic stress disorder. In response, Daegu Catholic university hospital psychiatry department conducted active psychiatric counseling for medical patients who are hospitalized in Corona's management hospital for confirmation of coronavirus infection. In this study, the content and results of the psychiatric consultation on patients in Corona Care Ward were verified retroactively, and the effects of COVID-19 patients' emotional state and psychological support and crisis intervention were assessed on their emotional state.

Patients who are admitted to the COVID-19 care unit of the Catholic University of Daegu Hospital are subject to consultation with the psychiatrist. By retrospectively reviewing the medical records of the request and the results of the subjects, We collected Socio-demographic information, medical severity (oxygen saturation, chest x-ray readings, medication being administered), clinical psychological scale (PHQ-9, GAD-7, PC-PTSD-5, AIS, P4, SF-36, SCL-90-R) This study evaluates whether there is a difference in psychological scale according to differences in socio-demographic status and medical severity, and compares psychological psychological measures before and after referral to mental health medicine to evaluate the effectiveness of psychiatric counseling.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 54
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

1. Patient admitted to the COVID-19 management ward of Daegu Catholic University Hospital

2. Patients who were consulted with a psychiatrist by a physician.

Exclusion Criteria:

1. When the subject is accompanied by a serious physical or neurological condition

2. In case of brain damage or concussion with loss of consciousness at the time of treatment

3. When it is difficult to understand psychological intervention due to the apparent decrease in intelligence at the time of treatment

4. When it is difficult to understand psychological intervention and follow examination instructions due to noticeable sensory damage such as hearing and vision at the time of treatment

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Psychiatric counseling
Patients who are admitted to the COVID-19 care unit of the Catholic University of Daegu Hospital are subject to consultation with the psychiatrist. By retrospectively reviewing the medical records of the request and the results of the subjects, We collected Socio-demographic information, medical severity (oxygen saturation, chest x-ray readings, medication being administered), clinical psychological scale (PHQ-9, GAD-7, PC-PTSD-5, AIS, P4, SF-36, SCL-90-R) This study evaluates whether there is a difference in psychological scale according to differences in socio-demographic status and medical severity, and compares psychological psychological measures before and after referral to mental health medicine to evaluate the effectiveness of psychiatric counseling.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Daegu Catholic University Medical Center

References & Publications (9)

Folkman S, Greer S. Promoting psychological well-being in the face of serious illness: when theory, research and practice inform each other. Psychooncology. 2000 Jan-Feb;9(1):11-9. Review. — View Citation

Kang L, Li Y, Hu S, Chen M, Yang C, Yang BX, Wang Y, Hu J, Lai J, Ma X, Chen J, Guan L, Wang G, Ma H, Liu Z. The mental health of medical workers in Wuhan, China dealing with the 2019 novel coronavirus. Lancet Psychiatry. 2020 Mar;7(3):e14. doi: 10.1016/S2215-0366(20)30047-X. Epub 2020 Feb 5. — View Citation

Lee SM, Kang WS, Cho AR, Kim T, Park JK. Psychological impact of the 2015 MERS outbreak on hospital workers and quarantined hemodialysis patients. Compr Psychiatry. 2018 Nov;87:123-127. doi: 10.1016/j.comppsych.2018.10.003. Epub 2018 Oct 13. — View Citation

Maunder R, Hunter J, Vincent L, Bennett J, Peladeau N, Leszcz M, Sadavoy J, Verhaeghe LM, Steinberg R, Mazzulli T. The immediate psychological and occupational impact of the 2003 SARS outbreak in a teaching hospital. CMAJ. 2003 May 13;168(10):1245-51. — View Citation

Okusaga O, Yolken RH, Langenberg P, Lapidus M, Arling TA, Dickerson FB, Scrandis DA, Severance E, Cabassa JA, Balis T, Postolache TT. Association of seropositivity for influenza and coronaviruses with history of mood disorders and suicide attempts. J Affect Disord. 2011 Apr;130(1-2):220-5. doi: 10.1016/j.jad.2010.09.029. Epub 2010 Oct 27. — View Citation

Park SC, Park YC. Mental Health Care Measures in Response to the 2019 Novel Coronavirus Outbreak in Korea. Psychiatry Investig. 2020 Feb;17(2):85-86. doi: 10.30773/pi.2020.0058. Epub 2020 Feb 25. — View Citation

Xiang YT, Yang Y, Li W, Zhang L, Zhang Q, Cheung T, Ng CH. Timely mental health care for the 2019 novel coronavirus outbreak is urgently needed. Lancet Psychiatry. 2020 Mar;7(3):228-229. doi: 10.1016/S2215-0366(20)30046-8. Epub 2020 Feb 4. — View Citation

Xiao C. A Novel Approach of Consultation on 2019 Novel Coronavirus (COVID-19)-Related Psychological and Mental Problems: Structured Letter Therapy. Psychiatry Investig. 2020 Feb;17(2):175-176. doi: 10.30773/pi.2020.0047. Epub 2020 Feb 25. — View Citation

Zhou X. Psychological crisis interventions in Sichuan Province during the 2019 novel coronavirus outbreak. Psychiatry Res. 2020 Feb 26;286:112895. doi: 10.1016/j.psychres.2020.112895. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change of PHQ-9 (Patient Health Questionnaire-9) for assess depressive symptom On admission and at the time of discharge, on average 2 months
Primary Change of GAD-7 (Patient Health Questionnaire-9) for assess anxiety symptom On admission and at the time of discharge, on average 2 months
Primary Change of PC-PTSD-5 (Primary Care PTSD Screen for DSM-5) for assess PTSD symptom On admission and at the time of discharge, on average 2 months
Primary Change of AIS (Athens Insomnia Scale) for assess insomnia On admission and at the time of discharge, on average 2 months
Primary Change of P4 (P4 Suicidality Screener) for assess suicidal idea On admission and at the time of discharge, on average 2 months
Primary Change of SF-36 (Short Form Health Survey Questionnaire) for assess health associated QoL On admission and at the time of discharge, on average 2 months
Secondary Change of SCL-90-R for assess other psychiatric symptoms On admission and at the time of discharge, on average 2 months
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