Impact of COVID-19 Pandemic on Patients with Serious Mental Illness (SMI) and Nonpsychiatric Control Subjects in Clinical Trials.

Journal: Innovations in clinical neuroscience

Volume: 21

Issue: 1-3

Year of Publication: 

Affiliated Institutions:  Ms. Fe Garcia-Rada and Dr. Litman are with CenExel CBH Health in Gaithersburg, Maryland.

Abstract summary 

This study aimed to examine the impact of the COVID-19 pandemic on patients with serious mental illness (SMI), specifically relating to psychiatric morbidity, pandemic-induced stress, and ability to cope with pandemic-related precautionary measures, restrictions, and disruptions to daily life.A cross-sectional survey study of 277 clinical trial patients was conducted. This sample included nonpsychiatric controls (n=139) and patients with a diagnosis of bipolar disorder, major depressive disorder (MDD), or schizophrenia (n=138) located at five clinical trial sites across the United States. A univariate analysis was performed to obtain general frequencies of the sample. Unpaired t-tests were used in comparing the groups on numerical variables, and analysis of variance (ANOVA) was performed to identify differences when comparing three or more categories.Patients with SMI were more likely to report wearing face masks, avoiding large gatherings, and endorsing the use of precautionary measures, despite receiving a COVID-19 vaccine (<0.001). A total of 70.3 percent (n=97) of all patients with SMI reported experiencing at least one episode of symptom worsening, 48 percent reported experiencing suicidal ideation, and 66 percent reported a need for increased mental healthcare due to COVID-19-related distress. Patients with SMI reported higher levels of stress, compared to controls, with patients with MDD having the highest levels of stress (<0.001).These findings demonstrate an increased vulnerability to symptom worsening in patients with SMI during a pandemic and suggest the need to account for pandemic-induced psychological stress in clinical trial design, subject selection, and symptoms ratings.

Authors & Co-authors:  Fe Garcia-Rada Litman

Study Outcome 

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Statistics
Citations :  Vindegaard N, Benros ME. COVID-19 pandemic and mental health consequences: systematic review of the current evidence. Brain Behav Immun. 2020;89:531–542.
Authors :  2
Identifiers
Doi : 
SSN : 2158-8333
Study Population
Male,Female
Mesh Terms
Other Terms
COVID-19;Clinical trials;mood disorders;pandemic;psychiatry
Study Design
Study Approach
Country of Study
Publication Country
United States