Covid19NCT04395872
Psychiatric Consultation for COVID-19 Patients
An observational study of Covid19 and Psychiatric Problem, run by Daegu Catholic University Medical Center.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19, Psychiatric Problem, Isolation, Social
- What is being tested?
- Psychiatric counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 28 May 2020to 31 Dec 2020
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have been confirmed as COVID-19 and admitted to the management ward, and consulted with a psychiatrist by a physician.
Who may be able to join
- Patient admitted to the COVID-19 management ward of Daegu Catholic University Hospital
- Patients who were consulted with a psychiatrist by a physician.
Who cannot join
- When the subject is accompanied by a serious physical or neurological condition
- In case of brain damage or concussion with loss of consciousness at the time of treatment
- When it is difficult to understand psychological intervention due to the apparent decrease in intelligence at the time of treatment
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed 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.
- Conditions
- Covid19, Psychiatric Problem, Isolation, Social
- Being tested
- Psychiatric counseling
- Keywords
- COVID-19, consultation
- Medical subject headings
- COVID-19, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Among patients who were confirmed as COVID-19 and admitted to the COVID-19 management ward of Daegu Catholic University Hospital, patients who were consulted by the Department of psychiatry was selected as participants. 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). were collected from participants. It evaluates whether there is a difference in the psychological scale according to the difference in participants' sociodemographic status and medical severity, and evaluates the effectiveness of psychiatric counseling by comparing clinical psychological measures before and after referral to department of psychiatry. Receives: Behavioral: Psychiatric counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of PHQ-9 (Patient Health Questionnaire-9)
for assess depressive symptom
Measured: On admission and at the time of discharge, on average 2 months
Change of GAD-7 (Patient Health Questionnaire-9)
for assess anxiety symptom
Measured: On admission and at the time of discharge, on average 2 months
Change of PC-PTSD-5 (Primary Care PTSD Screen for DSM-5)
for assess PTSD symptom
Measured: On admission and at the time of discharge, on average 2 months
Change of AIS (Athens Insomnia Scale)
for assess insomnia
Measured: On admission and at the time of discharge, on average 2 months
Change of P4 (P4 Suicidality Screener)
for assess suicidal idea
Measured: On admission and at the time of discharge, on average 2 months
Change of SF-36 (Short Form Health Survey Questionnaire)
for assess health associated QoL
Measured: On admission and at the time of discharge, on average 2 months
Secondary outcomes (1)
Change of SCL-90-R
for assess other psychiatric symptoms
Measured: On admission and at the time of discharge, on average 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start28 May 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daegu Catholic University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonghun Lee, Daegu Catholic University Medical Center
- Investigators
- Jonghun Lee, M.D., ph.D., Principal investigator, Daegu Catholic University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395872
- Sponsor's protocol ID
- CR-20-062
- Status last verified
- May 2020
- First submitted
- 8 May 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared on request for proper reason.
Publications
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. doi: 10.1002/(sici)1099-1611(200001/02)9:13.0.co;2-z.
PubMed 10668055Kang 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. No abstract available.
PubMed 32035030Lee 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.
PubMed 30343247Maunder 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.
PubMed 12743065Okusaga 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.
PubMed 21030090Park 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. No abstract available.
PubMed 32093458Xiang 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. No abstract available.
PubMed 32032543Xiao 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. No abstract available.
PubMed 32093461Zhou X. Psychological crisis interventions in Sichuan Province during the 2019 novel coronavirus outbreak. Psychiatry Res. 2020 Apr;286:112895. doi: 10.1016/j.psychres.2020.112895. Epub 2020 Feb 26. No abstract available.
PubMed 32120170
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Consultation for COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04395872
- Acronym / sponsor ID
- CR-20-062
- Conditions
- Covid19, Psychiatric Problem, Isolation, Social
- Keywords
- COVID-19, consultation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Daegu Catholic University Medical CenterUniversity, hospital or other
- Study start
- 28 May 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 20 May 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.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | Behavioral: Psychiatric counselingAmong patients who were confirmed as COVID-19 and admitted to the COVID-19 management ward of Daegu Catholic University Hospital, patients who were consulted by the Department of psychiatry was selected as participants. 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). were collected from participants. It evaluates whether there is a difference in the psychological scale according to the difference in participants' sociodemographic status and medical severity, and evaluates the effectiveness of psychiatric counseling by comparing clinical psychological measures before and after referral to department of psychiatry. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have been confirmed as COVID-19 and admitted to the management ward, and consulted with a psychiatrist by a physician.
Key inclusion criteria (2 listed)
- Patient admitted to the COVID-19 management ward of Daegu Catholic University Hospital
- Patients who were consulted with a psychiatrist by a physician.
Key exclusion criteria (4 listed)
- When the subject is accompanied by a serious physical or neurological condition
- In case of brain damage or concussion with loss of consciousness at the time of treatment
- When it is difficult to understand psychological intervention due to the apparent decrease in intelligence at the time of treatment
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychiatric counselingPatients 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. | Behavioural | COVID-19 |
Primary outcome
Change of PHQ-9 (Patient Health Questionnaire-9)
Time frame: On admission and at the time of discharge, on average 2 months
for assess depressive symptom
Change of GAD-7 (Patient Health Questionnaire-9)
Time frame: On admission and at the time of discharge, on average 2 months
for assess anxiety symptom
Change of PC-PTSD-5 (Primary Care PTSD Screen for DSM-5)
Time frame: On admission and at the time of discharge, on average 2 months
for assess PTSD symptom
Change of AIS (Athens Insomnia Scale)
Time frame: On admission and at the time of discharge, on average 2 months
for assess insomnia
Change of P4 (P4 Suicidality Screener)
Time frame: On admission and at the time of discharge, on average 2 months
for assess suicidal idea
Change of SF-36 (Short Form Health Survey Questionnaire)
Time frame: On admission and at the time of discharge, on average 2 months
for assess health associated QoL
1 secondary outcome
Change of SCL-90-R
Time frame: On admission and at the time of discharge, on average 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Background: PubMed 10668055Folkman 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. doi: 10.1002/(sici)1099-1611(200001/02)9:13.0.co;2-z.
- Background: PubMed 32035030Kang 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. No abstract available.
- Background: PubMed 30343247Lee 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.
- Background: PubMed 12743065Maunder 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.
- Background: PubMed 21030090Okusaga 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.
- Background: PubMed 32093458Park 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. No abstract available.
- Background: PubMed 32032543Xiang 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. No abstract available.
- Background: PubMed 32093461Xiao 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. No abstract available.
- Background: PubMed 32120170Zhou X. Psychological crisis interventions in Sichuan Province during the 2019 novel coronavirus outbreak. Psychiatry Res. 2020 Apr;286:112895. doi: 10.1016/j.psychres.2020.112895. Epub 2020 Feb 26. No abstract available.
- Individual participant dataSharing planned: No. Data will be shared on request for proper reason.
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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.
Jonghun Lee, M.D., ph.D. principal investigator
Daegu Catholic University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Psychiatric Problem, run by Daegu Catholic University Medical Center.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact geunhui Won, M.D. (+82-53-650-4780, guenheu@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of PHQ-9 (Patient Health Questionnaire-9) (time frame: On admission and at the time of discharge, on average 2 months). The study lists 6 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 NCT04395872, which also lists 9 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 27 May 2020.