Covid19NCT05119400
COVID-19 (Coronavirus Disease-2019) Psychiatric Outcomes
An observational study of Covid19 and Anxiety, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The goal of this longitudinal and observational study is to better understand the psychiatric consequences of COVID-19 over time. Psychiatric outcomes like mood, anxiety, stress, and cognitive symptoms in patients who underwent inpatient hospitalization at NewYork-Presbyterian Hospital/Weill Cornell Medicine for… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2021to 2 Apr 2024
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 60 patients who were previously hospitalized at NYP/WCM between March 1 and December 31, 2020 for a minimum of three days will be enrolled. Out of 60, 30 patients would have a past diagnosis of COVID-19 and 30 patients would have undergone hospitalization secondary to a medical diagnosis that was not COVID-19.
Who may be able to join
- Men and women age 18-89.
- Past diagnosis of COVID-19 with confirmed positive SARS-CoV-2 PCR test in electronic medical record
- English speaking
- Previously hospitalized at NYP/WCM between March 1 2020 and six months prior to enrollment for a minimum of three days.
- Men and women age 18-89
- English speaking
- Previously hospitalized at NYP/WCM between March 1 2020 and six months prior to enrollment for a minimum of three days.
- Underwent hospitalization secondary to a medical diagnosis that was not COVID-19
Who cannot join
- N/A
- Past diagnosis of COVID-19
- Admitted to inpatient hospitalization due to, or past history of, a primary central nervous system relation etiology such as stroke, brain tumor, encephalitis, traumatic brain injury, multiple sclerosis, or Parkinson's disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychiatric Outcomes Following Inpatient Hospitalization For COVID-19
The goal of this longitudinal and observational study is to better understand the psychiatric consequences of COVID-19 over time. Psychiatric outcomes like mood, anxiety, stress, and cognitive symptoms in patients who underwent inpatient hospitalization at NewYork-Presbyterian Hospital/Weill Cornell Medicine for COVID-19 will be assessed at 6 months or later post-discharge.
- Conditions
- Covid19, Anxiety, Mood, Cognitive Impairment
- Keywords
- Psychiatric Outcome, Inpatient Hospitalization
- Medical subject headings
- COVID-19, Anxiety Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 group | COVID-19 group will be made up of 30 patients that have a past diagnosis of COVID-19 with confirmed positive SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) PCR (polymerase chain reaction) test in their electronic medical record and were previously hospitalized at NYP/WCM (NewYork Presbyterian/ Weill Cornell Medicine) between March 1 and December 31, 2020 for a minimum of three days. Administration of study instruments, including self-report measures of mood, anxiety, post-traumatic stress and adjustment, and objective neuropsychological tests of cognitive function will be done via telephone interview, videoconference interview, and/or Redcap survey for both groups. | |
| Comparison group | The subjects in comparison group will be 30 patients previously hospitalized at NYP/WCM between March 1 and December 31, 2020 for a minimum of three days. The recruited subjects would have undergone hospitalization secondary to a medical diagnosis that was not COVID-19. Administration of study instruments, including self-report measures of mood, anxiety, post-traumatic stress and adjustment, and objective neuropsychological tests of cognitive function will be done via telephone interview, videoconference interview, and/or Redcap survey for both groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive functioning as measured by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (English)
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) comprises auditory and visual subtasks of attention, language, visuospatial/constructional abilities, and immediate and delayed memory. Each subtask is assessed as accuracy (number of correct responses) and subsequently combined into a composite score (RBANS Total Scale score).
Measured: Once, 6 months to 36 months post-discharge from the hospital.
Secondary outcomes (11)
Executive functioning as measured by the Oral Trail Making Test-B (OTMT-B; English)
The oral version of the Trail Making Test (OTMT) assesses processing speed, working memory, and attention. Participants have to say out loud numbers and letters in alternating sequence and the time to completion is recorded.
Measured: Once, 6 months to 36 months post-discharge from the hospital.
Cognitive control as measured by the Stroop test (English)
The Stroop Color and Word Test (SCWT) is used to assess verbal processing speed and ability to inhibit cognitive interference. Participants have to read out loud words, colors, and color words printed in different colored ink. The number of correct responses in 45 seconds is recorded.
Measured: Once, 6 months to 36 months post-discharge from the hospital.
Verbal intellectual ability as measured by the National Adult Reading Test (NART) for English speakers and the Word Accentuation Test (WAT).
Participants have to read a set of words out loud and the number correct is recorded. Number of errors are recorded out of 61 words.
Measured: Once, 6 months to 36 months post-discharge from the hospital.
Verbal Fluency (English)
This test requires participants to verbally produce words that start with given letters in a given time. The number of total valid words is used to indicate of successful selective information retrieval from memory.
Measured: Once, 6 months to 36 months post-discharge from the hospital.
Mood symptoms as assessed by DASS (English)
Participants' moods will be assessed by Depression and Anxiety Scale (DASS) which is 42 item quantitative measure of three related negative emotional states of depression, anxiety and stress. The scores are interpreted for all three areas and higher scores indicate that the participant experiences increased emotional distress in either or all areas. For depression, the score ranges of 0-9 mean normal, 10-13 is mild, 14-20 moderate, 21-27 severe, and 28+ would be categorized under extremely severe depression. For anxiety, 0-7 is normal, 8-9 mild, 10-14 moderate, 15-19 severe, 20+ extremely severe. And for Stress, 0-14 is normal, 15-18 mild, 19-25 moderate, 26-33 severe, and 34+ extremely severe.
Measured: Once, 6 months to 36 months post-discharge from the hospital.
Mood symptoms as assessed by PANAS (English)
The Positive and Negative Affect Schedule (PANAS) is a 20-item scale to measure affect. The scale consists of different words that alternate between positive and negative affect and each item is rated on a 5 point scale. Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.
Measured: Once, 6 months to 36 months post-discharge from the hospital.
Acceptance as assessed by AAQ-II (English)
The Acceptance and Action Questionnaire (AAQ) is a 7-item self-report questionnaire used to measure psychological inflexibility and experiential avoidance. Scores range from 7- 49 with higher scores indicating higher level of inflexibility/avoidance.
Measured: Once, 6 months to 36 months post-discharge from the hospital.
Resilience as assessed by Brief Resilience Scale (English)
The Brief Resilience Scale (BRS) is 6-item questionnaire used to assess the participant's perceived ability to recover from stressful events. The possible score range on each item is from 1 (low resilience) to 5 (high resilience).
Measured: Once, 6 months to 36 months post-discharge from the hospital.
Cognitive difficulties in daily life as assessed by Neuro Quality of Life (NeuroQOL) (English)
NeuroQOL is a self-report questionnaires used to determine cognitive difficulties in participants' tasks of daily living. Scores range from 8-40 where lower score indicate that the participant experiences cognitive difficulties in their daily tasks and higher scores indicate minimum or no cognitive difficulties.
Measured: Once, 6 months to 36 months post-discharge from the hospital.
Cognitive function as assessed by Attention Network Test (ANT)
ANT is a validated and computer-based paradigm that is based on an underlying attention/executive function network model of attention. It assesses three components of attention: alerting attention, orienting attention, and executive attention.
Measured: Once, 6 months to 36 months post-discharge from the hospital.
Cognitive function as assessed by EEG.
An event-related potential (ERP) is the stereotypical voltage change that occurs in brain structures following specific cognitive events. When recorded using EEG, they are a powerful noninvasive method to study neural correlates of mental processes. We will record EEG while subjects engage in passive auditory cognitive processing and extract specific ERP components that are known to be sensitive to subtle cognitive weaknesses (N100, P300, N400).
Measured: Once, 6 months to 36 months post-discharge from the hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start17 Dec 2021
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Why it stopped: Unable to recruit staff or funding to complete the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abhishek Jaywant, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119400
- Sponsor's protocol ID
- 20-08022609
- Status last verified
- Apr 2024
- First submitted
- 27 Oct 2021
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported, after deidentification, will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Outcomes Following Inpatient Hospitalization For COVID-19
- ClinicalTrials.gov ID
- NCT05119400
- Acronym / sponsor ID
- 20-08022609
- Conditions
- Covid19, Anxiety, Mood, Cognitive Impairment
- Keywords
- Psychiatric Outcome, Inpatient Hospitalization
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to recruit staff or funding to complete the study
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 15 Nov 2021 (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.
The goal of this longitudinal and observational study is to better understand the psychiatric consequences of COVID-19 over time. Psychiatric outcomes like mood, anxiety, stress, and cognitive symptoms in patients who underwent inpatient hospitalization at NewYork-Presbyterian Hospital/Weill Cornell Medicine for COVID-19 will be assessed at 6 months or later post-discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 group | – | –COVID-19 group will be made up of 30 patients that have a past diagnosis of COVID-19 with confirmed positive SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) PCR (polymerase chain reaction) test in their electronic medical record and were previously hospitalized at NYP/WCM (NewYork Presbyterian/ Weill Cornell Medicine) between March 1 and December 31, 2020 for a minimum of three days. Administration of study instruments, including self-report measures of mood, anxiety, post-traumatic stress and adjustment, and objective neuropsychological tests of cognitive function will be done via telephone interview, videoconference interview, and/or Redcap survey for both groups. |
| Comparison group | – | –The subjects in comparison group will be 30 patients previously hospitalized at NYP/WCM between March 1 and December 31, 2020 for a minimum of three days. The recruited subjects would have undergone hospitalization secondary to a medical diagnosis that was not COVID-19. Administration of study instruments, including self-report measures of mood, anxiety, post-traumatic stress and adjustment, and objective neuropsychological tests of cognitive function will be done via telephone interview, videoconference interview, and/or Redcap survey for both groups. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 patients who were previously hospitalized at NYP/WCM between March 1 and December 31, 2020 for a minimum of three days will be enrolled. Out of 60, 30 patients would have a past diagnosis of COVID-19 and 30 patients would have undergone hospitalization secondary to a medical diagnosis that was not COVID-19.
Key inclusion criteria (8 listed)
- Men and women age 18-89.
- Past diagnosis of COVID-19 with confirmed positive SARS-CoV-2 PCR test in electronic medical record
- English speaking
- Previously hospitalized at NYP/WCM between March 1 2020 and six months prior to enrollment for a minimum of three days.
- Men and women age 18-89
Key exclusion criteria (3 listed)
- N/A
- Past diagnosis of COVID-19
- Admitted to inpatient hospitalization due to, or past history of, a primary central nervous system relation etiology such as stroke, brain tumor, encephalitis, traumatic brain injury, multiple sclerosis, or Parkinson's disease.
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
Cognitive functioning as measured by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (English)
Time frame: Once, 6 months to 36 months post-discharge from the hospital.
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) comprises auditory and visual subtasks of attention, language, visuospatial/constructional abilities, and immediate and delayed memory. Each subtask is assessed as accuracy (number of correct responses) and subsequently combined into a composite score (RBANS Total Scale score).
11 secondary outcomes
Executive functioning as measured by the Oral Trail Making Test-B (OTMT-B; English)
Time frame: Once, 6 months to 36 months post-discharge from the hospital.
Cognitive control as measured by the Stroop test (English)
Time frame: Once, 6 months to 36 months post-discharge from the hospital.
Verbal intellectual ability as measured by the National Adult Reading Test (NART) for English speakers and the Word Accentuation Test (WAT).
Time frame: Once, 6 months to 36 months post-discharge from the hospital.
Verbal Fluency (English)
Time frame: Once, 6 months to 36 months post-discharge from the hospital.
Mood symptoms as assessed by DASS (English)
Time frame: Once, 6 months to 36 months post-discharge from the hospital.
Mood symptoms as assessed by PANAS (English)
Time frame: Once, 6 months to 36 months post-discharge from the hospital.
Acceptance as assessed by AAQ-II (English)
Time frame: Once, 6 months to 36 months post-discharge from the hospital.
Resilience as assessed by Brief Resilience Scale (English)
Time frame: Once, 6 months to 36 months post-discharge from the hospital.
Cognitive difficulties in daily life as assessed by Neuro Quality of Life (NeuroQOL) (English)
Time frame: Once, 6 months to 36 months post-discharge from the hospital.
Cognitive function as assessed by Attention Network Test (ANT)
Time frame: Once, 6 months to 36 months post-discharge from the hospital.
Cognitive function as assessed by EEG.
Time frame: Once, 6 months to 36 months post-discharge from the hospital.
Results and safety
The study was stopped early (reason given: Unable to recruit staff or funding to complete the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported, after deidentification, will be shared.
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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.
Abhishek Jaywant, PhD principal investigator
Weill Medical College of Cornell University
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 Covid19 and Anxiety, run by Weill Medical College of Cornell University 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 8 inclusion and 3 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: stopped early, as of the sponsor's last update on 12 Apr 2024. 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 was stopped early (reason given: Unable to recruit staff or funding to complete the study). Results are not available in the source record.
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?
Cognitive functioning as measured by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (English) (time frame: Once, 6 months to 36 months post-discharge from the hospital.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2024.