Coronavirus disease 2019 (COVID-19) has created a global pandemic and disrupted our society and daily lives. Americans have been forced to separate from their workplaces and their friends, engage in previously foreign behaviors including “social distancing” and “sheltering in place,” and unemployment rates have jumped to unprecedented highs. The media have mainly focused on the psychological effects of COVID-19 in the general public, largely overlooking its impact on the most vulnerable groups in our society. The aim of this paper is to present the protocol for a study that will examine the effect of the pandemic on people with serious mental illness (SMI).

A recently published review in Lancet Psychiatry outlined the heightened risk of COVID-19 transmission among people with mental health disorders [1]. In addition to increased risk for infection, people with mental health disorders, and particularly those with SMI, could experience greater susceptibility to emotional responses to the pandemic, such as fear, anxiety, stress, depression, as well as risk of relapse or worsening of positive (eg, paranoia, hallucinations) and negative (eg, anhedonia, apathy) psychotic symptoms. This could be due to several reasons, including higher vulnerability to stress compared to the general population [2,3], reduced access to resources to permit ongoing mental health treatment and services [4,5], greater job or food insecurity [6,7], and additional restrictions in existing congregated situations such as group homes [8]. Social isolation or distancing may be less discrepant from daily living in some people with SMI than the general population. Moreover, some people with SMI may be less engaged in social networks and standard news media. Thus, the hypothesis of reduced subjective stress compared to the population in general needs to be considered.

On the other hand, health messages and awareness of the crisis are quite likely to not be well disseminated to people with SMI, creating a public health risk for individuals with SMI and others with whom they may have contact. An additional issue is challenges in the ability to understand and comply with complex directives and precautionary measures. People with SMI represent about 2%-3% of the population, and COVID-19 may result in collective increases in symptom severity, which, in turn, could result in expansive increases in mortality, emergency care utilization, and distress. Thus, it is critical to understand the influences of the COVID-19 pandemic on people with SMI. Further, our previous research has suggested that people with SMI are particularly challenged in self-assessments of both their emotional states and of their ability to engage in productive behaviors targeting their everyday functioning and self-management [9,10].

Our research team has two ongoing studies centered around Strategy 3.1 of the National Institute of Mental Health’s (NIMH) strategic plan to “identify and validate new targets for treatment development that underlie disease mechanisms” [11]. Both studies are multisite collaborations between the University of Texas at Dallas, University of California San Diego, and the University of Miami. Study 1 (principal investigator [PI]: author AEP, R01MH112620) assesses the construct of introspective accuracy, or the ability to correctly judge one’s own skills and abilities. The goals of this study are (1) to learn how impaired introspective accuracy in individuals with serious mental illness contributes to difficulties in real-world functioning, (2) to understand how introspective accuracy differs from other types of self-awareness, and (3) to discover how clinical symptoms affect the amount and direction of introspective accuracy impairments among outpatients with serious mental illness. To date, 189 participants aged 18-60 years have completed the study protocol (101 with schizophrenia or schizoaffective disorder, 72 with bipolar disorder, 16 controls; see Table 1 for baseline demographic and clinical characteristics of the sample), which includes an in-person, lab-based assessment followed by 30 days of at-home symptom tracking and cognitive testing via smartphone-based ecological momentary assessment (EMA). The goals of study 2 (PI: author CAD, R01MH116902) are to understand, over a 1-year period, how cognitive biases in the ways that outpatients with psychotic disorders (eg, schizophrenia, bipolar disorder with psychosis) perceive other people impact suicidal ideation and behavior. Ninety-seven participants aged 18-65 years have completed baseline assessments (38 with schizophrenia, 41 with schizoaffective disorder, 16 with bipolar disorder with psychosis, 2 with major depressive disorder and psychosis; see Table 2 for baseline demographic and clinical characteristics of the sample). Similar to study 1, the baseline assessments for study 2 include an in-person, lab-based assessment followed by 10 days of in-the-moment reports of symptoms and performance-based social cognition assessments via smartphone-based EMA.

We also have one study that responds to NIMH Strategic Aim 2.2 [12] to develop novel behavioral assessments to evaluate domains relevant to mental illness. This is a single-site study at UCSD (PI: author RCM, R21MH116104) with the goals of understanding the real-time effects of mood on real-world cognitive performance and discovering how real-world cognition relates to real-time daily functioning among individuals with bipolar disorder. Sixty-six participants aged 18-65 years have completed this study (36 with bipolar disorder I, 10 with bipolar disorder II, 20 controls; see Table 3 for baseline demographic and clinical characteristics of the sample), which included a baseline assessment followed by 14 days of smartphone-based EMA and mobile cognitive testing (administered 3 times per day for a total possibility of 42 EMAs per participant).

For the present study, we will follow up with these previously enrolled research participants to assess their current mental health and psychosocial functioning with the exact same questions that were utilized during their previous participation. This study design will allow us to directly compare participants’ prepandemic mental health functioning, based on dense sampling of their momentary responses regarding symptoms, functioning, and self-evaluations with mental health functioning during the acute phase of the COVID-19 pandemic. We will also be positioned to examine demographic, cognitive, and psychosocial factors that may be predictive of better and worse mental health outcomes in this unprecedented time. Therefore, the aims of this study are to learn about (1) the mental health impact of COVID-19 and social distancing behaviors among at-risk populations and (2) prevention behaviors taken to reduce the risk of COVID-19 infection among persons with SMI. In so doing, we will use a comprehensive and detailed set of previously collected EMA data (up to 90 observations per patient collected over a 30-day sampling period) and ask those same questions again in two telephone reassessments: the first round of telephone assessments will occur between April 3, 2020, and May 31, 2020; the second round will occur 1 month after reopening. Although this will differ by state, we anticipate a date between June 1, 2020, and August 31, 2020. Our results should provide vital information regarding the overall level of awareness individuals with SMI have regarding the health risks of COVID-19 and how it is currently impacting their daily lives.

The inclusion of participants for the first round of telephone assessments started on April 3, 2020 and will be completed by May 31, 2020. As of April 30, 2020, 101 individuals had completed these first-round assessments. The second round of telephone assessments will likely occur between June 1, 2020, and August 31, 2020. Study results will be published in peer-reviewed scientific journals in a timely fashion at completion of data collection. Data addressing non-COVID-19 topics from the sample collected to date are already being submitted for publication to scientific journals.