COVID-19 (Coronavirus Disease-2019) Psychiatric Outcomes

Anxiety Clinical Trial

Official title:

Psychiatric Outcomes Following Inpatient Hospitalization For COVID-19

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05119400
• Other study ID #: 20-08022609
• Status: Terminated
• Start date: December 17, 2021
• Est. completion date: April 2, 2024

Study information

• Verified date: April 2024
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 COVID-19 will be assessed at 6 months or later post-discharge.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 2, 2024
• Est. primary completion date: April 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria-COVID-19 group:

• 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.

Inclusion Criteria-Comparison group:

• 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

Exclusion Criteria--COVID-19 group:

N/A

Exclusion Criteria--Comparison group:

• 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.

Related Conditions & MeSH terms

• Anxiety
• Cognitive Impairment
• COVID-19
• Covid19
• Mood

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Once, 6 months to 36 months post-discharge from the hospital.
Secondary	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.	Once, 6 months to 36 months post-discharge from the hospital.
Secondary	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.	Once, 6 months to 36 months post-discharge from the hospital.
Secondary	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.	Once, 6 months to 36 months post-discharge from the hospital.
Secondary	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.	Once, 6 months to 36 months post-discharge from the hospital.
Secondary	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.	Once, 6 months to 36 months post-discharge from the hospital.
Secondary	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.	Once, 6 months to 36 months post-discharge from the hospital.
Secondary	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.	Once, 6 months to 36 months post-discharge from the hospital.
Secondary	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).	Once, 6 months to 36 months post-discharge from the hospital.
Secondary	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.	Once, 6 months to 36 months post-discharge from the hospital.
Secondary	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.	Once, 6 months to 36 months post-discharge from the hospital.
Secondary	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).	Once, 6 months to 36 months post-discharge from the hospital.