|Year : 2021 | Volume
| Issue : 3 | Page : 215-220
Challenges in Conducting Mental Health Research during the Coronavirus Disease 2019 Pandemic and Approaches to Handle Them
Mamta Sood, Nishtha Chawla, Tulika Shukla, Rekha Patel, Jasmine Bhogal, Rakesh Kumar Chadda
Department of Psychiatry, All India Institute of Medical Sciences, New Delhi, India
|Date of Submission||22-Nov-2021|
|Date of Decision||02-Dec-2021|
|Date of Acceptance||10-Dec-2021|
|Date of Web Publication||23-Dec-2021|
Prof. Rakesh Kumar Chadda
Department of Psychiatry, All India Institute of Medical Sciences, New Delhi
Source of Support: None, Conflict of Interest: None
Coronavirus disease 2019 (COVID-19) disease led to the disruption of many nonessential activities in health care across the globe including various non-COVID-19-related research activities. Various issues need to be addressed while conducting research during the pandemic. It is important to ensure the social and scientific value of research while ensuring to maintain ethical standards of the research. Taking the informed consent is of utmost priority irrespective of the platform of research. Any deviations from the protocol must be informed to the ethics committee. The confidentiality and privacy concerns should also be maintained higher up in the priority. Other concerns include regular audits with the management of the data, managing the workforce while ensuring their safety, handling administrative issues, and addressing researchers' burnout. During the pandemic, the research could either be conducted online or offline with both researchers and participants following covid-related protocol such as wearing mask, maintaining safe social distance, and maintaining hand hygiene. During the pandemic, authors were working on three funded research projects. The pandemic period can be divided into two phases in India: March 2020 to February 2021 and April 2021 to August 2021. During the first phase, our research activities proceeded in three stages. First stage (March 2020–May 2020) was characterized by uncertainty and complete stoppage of work. In second stage (Jun 2020–Sep 2020), work was done in online mode with recalibration of goals. In third stage (October 2020–March 2021), physical working had started with certain restrictions. During the second phase, all stages were shorter.
Keywords: Behavioural research, coronavirus disease 2019, mental health research, pandemic, research
|How to cite this article:|
Sood M, Chawla N, Shukla T, Patel R, Bhogal J, Chadda RK. Challenges in Conducting Mental Health Research during the Coronavirus Disease 2019 Pandemic and Approaches to Handle Them. World Soc Psychiatry 2021;3:215-20
|How to cite this URL:|
Sood M, Chawla N, Shukla T, Patel R, Bhogal J, Chadda RK. Challenges in Conducting Mental Health Research during the Coronavirus Disease 2019 Pandemic and Approaches to Handle Them. World Soc Psychiatry [serial online] 2021 [cited 2022 Jan 23];3:215-20. Available from: https://www.worldsocpsychiatry.org/text.asp?2021/3/3/215/333432
| Introduction|| |
The Coronavirus disease 2019 (COVID-19) pandemic is of unprecedented global public health concern. Stay-at-home (lockdown) orders were deployed across all the countries as a non-pharmaceutical public health intervention to control COVID-19 transmission. This led to reduction or cessation of all nonessential activities by the general population, and health-related resources were diverted from routine and non-COVID-related activities to COVID-related activities. Essential mental health services were disrupted in 93% of countries worldwide due to the pandemic. Telemedicine emerged as an important alternative for service provision and was adopted by nearly 70% of the countries and became a pivotal tool in the task of ensuring the continuous provision of mental health care.,
COVID-19 not only affected the psychological well-being of individuals including health-care professionals but also affected the behavioral and mental health research as well., Psychiatric research requires face-to-face, in-person, clinical interviews. However, during the pandemic, online platforms were used to conduct mental health research. Ethical concerns like taking informed consent from patients, particularly from those with a lack of judgment, issues of data privacy, and confidentiality need to be considered in data collection using online platforms. In addition, there are issues such as low response rate and difficulty in assessing the dysfunction through online surveys. Qualitative studies, which play a significant role in mental health and behavioral research, faced more impact, since these also require assessment of nonverbal communication. Whether conducted online or offline using COVID-19 appropriate behavior, assessment of nonverbal communication is likely to be affected as protective masks are likely to mask the facial and nonverbal gestures, which play a major role in qualitative research., Moreover, the diversion of available health resources and research funding towards COVID-related services and research left little scope for conducting non-COVID-related research in any specialty, let alone mental and behavioral research. The pandemic also led to halt in several ongoing or planned research activities as well.
On the other hand, the COVID-19 pandemic resulted in unprecedented research worldwide in pandemic-related subjects. Of the trials registered early in the pandemic till late 2020, it was noted that there were frequent overlaps in methodologies, fluctuation in the sample size, and lack of rigorous scientific standards, thus affecting the scientific validity of the studies. It has been emphasized that the urgency to conduct research during the crisis is not an excuse to overlook the ethical and scientific standards of conducting the study. The impact on research not only entails to the designing and conduct of research but to the publication of its results as well. A large section of the published literature pertained to letters, commentaries, and opinion papers, that too from high-income countries. The paucity of COVID-19 related mental health publications in low- and middle-income countries has also been highlighted in the literature. The primary reason behind this paucity is the disruption of traditional practice of research interviews in face-to-face interaction. However, this also presented an opportunity for mental health researchers to study the interaction between COVID-19 and mental health, for example, social issues such as intimate partner violence and domestic violence amidst restricted social mobility, impact of comorbid psychiatric illness in patients affected with COVID-19, coping among individuals with psychiatric illness during the pandemic, and neuropsychiatric underpinnings of COVID-19. A very pertinent but overlooked issue was burnout amongst researchers. Excessive use of technology and digital platforms were required to conduct research during the pandemic, which are also the most often used platforms for leisure thus blurring the boundaries between work and leisure. This could affect the productivity of the researchers, eventually affecting the outcome and quality of the research. Some other issues included delay in obtaining ethical clearance or receiving funding.
This paper summarizes the challenges to mental health research during the pandemic and approaches used to meet them, and a brief narrative of experience of authors in handling their ongoing research during the crisis period.
| Issues Related to Design and Conduct of the Research|| |
Social and scientific value
The primary purpose of conducting any research is in addition to scientific understanding, clinical significance, benefit to the participants in long run and replicability across diverse cultures. One should develop a proposal taking into consideration the principles of beneficence and nonmaleficence. In the current situation, the researchers may reprioritize their research and utilize this opportunity to explore the interface between COVID-19 and mental health. One important area of research could be intervention studies that reflect the specific needs of the patient population and are readily implementable. For patients in low-income countries, interventions should be affordable and rapidly available.,
Pandemic warranted research to find solutions to address the disease and its associated suffering. However, understandably clinical care took precedence over any research activity. During the pandemic, the health-care systems were overwhelmed, and resources were diverted. In the background of reallocation of resources as well as to have a wider representation of population, multicentric studies were planned. Conducting multicentric studies was challenging, since laws and regulations might vary from region to region.
The study designs were restricted by the COVID-19 precautions. Choice of an appropriate sampling strategy was affected due to social distancing measures. Randomization might not be possible with pandemic-related restrictions. Accessibility to research participants, especially control groups was also reduced. It was not uncommon to witness the protocols of ongoing studies being affected, leading to difficulty in completion. Thus, to adapt to or compensate for such changes, one tended to look for alternative strategies, such as using virtual modes to obtain data. These designs needed to be prespecified in protocols, prospectively registered, and analyzed accordingly. Researchers could also take this as an opportunity to design research studies which could facilitate understanding of mental health conditions caused or precipitated due to the COVID-19 pandemic. Interdisciplinary collaborations with respect to the mental health impact of COVID-19 and newer models of mental health care delivery were encouraged. It was also important for the researchers to design and complete studies within a short time frame so that the findings were still relevant.
Even if difficult, randomization is to be encouraged. Decentralized clinical trials conducted across satellite sites using virtual methods could improve the feasibility. An adaptive approach needed to be adopted to permit dynamic changes in the endpoints according to interim analysis results. Thus, the end points of the study were to be selected carefully.
Harmonization amongst national and international regulatory bodies
Governments and key regulatory bodies took steps to advance the international harmonization of multicentric studies. International Council for Harmonization developed guidelines such as Medical Dictionary for Regulatory Activities for pharmaceutical products, and Corona Accelerated RandD in Europe consortium was supported by the Innovative Medicines Initiative public–private partnership.
Due to the COVID-19-related restrictions, external audits were not possible. In such cases, various modifications needed to be done, namely, postponing or extending period between on-site monitoring visits, video or phone calls (virtual mode) that may be supplemented with centralized monitoring and review. As and when the pandemic would end, robust visits and monitoring could return to the prepandemic processes. If there were any protocol deviations due to the COVID-19 pandemic, these were to be documented. Researchers had to ensure that deviations were in the best interest of the participants without exposing them to unnecessary risks.
Data analysis and integrity
It is important that the collected data were managed appropriately. Patient folders needed to contain completed informed consent forms, screening sheets clarifying inclusion and exclusion criteria, patient case record forms, laboratory values, and a record of all communication with the subject. Data safety monitoring boards, independent of the investigators, were to be made available to evaluate interim data.
Issues related to ethics
Ethical issues in research are of paramount importance. There had been contrasting views regarding the conduct of research during the pandemic. One view was whether conducting research amidst a pandemic was ethical as research might take away resources needed for clinical care. The other school of thought was that pandemic offered the best opportunity to conduct research., According to the WHO Research Ethics Review Committee, conducting research is an ethical obligation during a public health emergency/pandemic as it may be necessary to produce new evidence which may eventually save lives. The major challenge, however, is the allocation of already limited health-care resources toward research without compromising clinical care. Various apex bodies across the globe involved in formulating, coordinating, and promoting biomedical research such as Centers for Disease Control and Prevention, National Institutes of Health, and Indian Council of Medical Research (ICMR) released guidelines for continuing research during the COVID-19 pandemic highlighting how to adapt the methodology as the pandemic unfolds.
Research funding agencies and ethics committees could be approached for taking permission for revision of study protocols to allow for data collection using online applications and platforms. The rise in data collection through digital platforms, especially with open-source software programs, raised many issues related to privacy. The research protocols had to be planned in a way to only collect essential core data and follow-up assessments to be kept minimum to reduce the burden on the research team. In some studies, such modifications were not feasible and required face-to-face monitoring and frequent visits., In such cases, participant visits were to be conducted using all protective measures.
While recruiting participants and collecting data via online platforms or on telephone or video calls, there must be provision for taking informed consent. In subjects with poor judgment, which could be a likely scenario in patients with psychiatric illness, the consent of a legally authorized representative could be taken. The procedure of taking consent could vary from taking verbal consent initially in the presence of a witness and getting signatures, once physical interviews were feasible to taking electronic consent/virtual e-consent directly. In the latter case, it was important to ensure a method to verify the identity of the participant.
During the pandemic, the research staff carrying out data collection may fall ill or may be assigned to COVID-19–related duties. Research staff may be <concerned about the added risk of infection during in-person visits. Making appropriate information and counseling available could help allay some of these worries. The principal investigators would need to monitor the staffing of their facility and prioritize the outcome measures with particular attention to visits/measures that could be collected over the phone, telehealth, or video chats.
The principal investigators of the research are best qualified to determine whether their studies can be safely continued as such, continued with modifications, or temporarily halted. They should anticipate disruptions to the study and inform the funding agencies and regulatory bodies promptly. Clinical researchers can play a significant role in helping institutional review boards with approval of the use of mobile apps, Skype, Facetime, and other remote platforms to conduct research visits. The principal investigators must consider making practical and feasible decisions to reprioritize their ongoing research work after weighing the risk versus benefits of continuing the research in its previous form.
The impact on mental health of health-care professionals has been studied. However, the impact of a pandemic on the mental health researchers, unlike other professionals, has not been studied. Research exploring the burnout among mental health researchers may prove beneficial in enhancing their well-being, thereby increasing their productivity and eventually the quality of mental health research.
| Authors' Experience of Handling Research Projects During the Pandemic|| |
During the pandemic, the authors were running three National Institute of Health Research funded projects as part of Warwick-India-Canada Psychosis Research Group (July 2017-January 2022). Two of these projects were based on patients with first-episode psychosis, while the third was on patients with chronic schizophrenia and related disorders. In all the three projects, the major tasks involved were screening of the patients attending services, recruitment of the subjects, conducting assessment on various scales at baseline, and planned follow-ups at 1, 3, 6, and 12 months. In all the three projects, over and above the treatment as usual provided by the clinical care team, research team provided booklet and mobile app-based psychosocial interventions.
These projects were conducted in outpatient setting of a tertiary care public-funded general hospital psychiatric unit (GHPU) of a medical school in North India. The GHPU has a 32-bedded inpatient facility and round-the-clock psychiatry emergency services, consultation-liaison services, community services, and specialty clinics. It caters to the patients from the national capital region of the country, as well as adjoining states, for example, in 2019–2020, the department provided outpatient services to 14,409 new cases and 68,706 follow-up cases with inpatient management for 301 patients. Principal investigators (RKC, MS) of the projects are faculty in the department and are responsible for teaching medical and nursing undergraduates and postgraduates, providing inpatient and outpatient clinical care, and handling various administrative responsibilities in addition to their research responsibilities. Research staff (NC, TS, JB, and RP) employed in the projects were responsible for research activities of three projects.
There was a complete lockdown from late March to May 2020 and April to June 2021 with partial restoration of services in between. Outpatient services were stopped, and inpatient services ran at minimal capacity. The research activities were considered nonessential, and the research staff was asked to work from home. We could identify two cycles coinciding with the first and second wave of the pandemic in India: March 2020 to February 2021 and March 20021 to August 2021. We could discern distinct phases in carrying out of research activities in a cycle: First phase– uncertainty and complete stoppage of work; second phase – work from home and recalibration of goals and actions; third phase– coming physically to workplace, familiarizing with, and working in a new reality. We describe the first cycle as follows:
Phase I (March 2020–May 2020)
First phase involved complete lockdown across the nation with stoppage of most research activities. All individuals, including the research staff, faced various uncertainties around the pandemic, its consequence, its impact on the person as well as the professional life, understanding measures to ensure safety, etc., Only essential services were running, with closure of public transport, making it difficult to commute to the workplace. There was reallocation of the workforce and clinical services from general health care to COVID-related services. All health-care staff was provided training to follow COVID-related protocols for prevention and treatment. Research activities were completely halted. Regular outpatient services were replaced by telemedicine consultations, though emergency services were continuing with limited beds for non-Covid care. The academics/teaching were shifted to virtual mode. Eventually, there was some clarity into how research was to be conducted during the pandemic. This was possible due to information, actions, guidelines, and policy directives issued from our hospital as well as the ICMR. We resumed our weekly meetings for the updates of the three projects using online platform.
Phase II (Jun 2020–September 2020)
The outpatient services resumed on June 8, 2020, although with minimal capacity (10 new patients could register as against more than 80 new patients in routine clinic). The availability of public transport remained limited, and the research staff were advised to work from home as per the hospital's policy. As the planned research tasks such as recruitment and follow ups of subjects could not be done, the investigators recalibrated the deliverables.
The research team made a list of the tasks that could be done remotely in the projects: follow-up of the recruited patients telephonically, updating and testing of the mobile app developed during the project, data entry, data cleaning, data analysis, writing reports, and preparing manuscripts of the available data. These activities were started. Monthly update was sent to the collaborators to document the impact of the COVID-19 pandemic on the project deliverables. The work was coordinated through e-mails, online platforms, and phone. Physical case record forms (containing data recorded before the pandemic) were collected and data entry was started by research staff.
While interviewing patients and their caregivers on phone for follow-ups, the impact of lockdown and ongoing COVID-19 pandemic on the mental health and functioning was quite apparent in the conversations. On review of literature, we found a lack of research on the impact of pandemic on persons with psychotic disorders, especially those staying in low-and middle-income countries. This motivated us to carry out new research on the same patients. A semi-structured questionnaire was designed to interview the patients telephonically to elicit information related to COVID-19 pandemic. After taking ethical clearance, the study was initiated.
Phase III (October 2020–March 2021)
The outpatient services were restarted in full capacity with COVID safety protocols. The research staff gradually adapted to coming to the hospital adhering to safety protocols as public transport became regular. Recruitment of the new subjects was started in October 2020. However, the physical contact and meetings were kept to minimum. Weekly online meetings for the updates continued.
With second wave of pandemic striking the national capital region by the end of March 2021, the outpatient services had to be shut down again from April 2021 to curb the spread of COVID-19. However, in second cycle (April 2021 to August 2021), all phases were shorter, and learnings from first cycle guided our response. During the first phase of completed shut down (April 2021 to May 2021), we continued our remote activities. From June 2021, partial resumption of services began. And by July 2021, all activities resumed in physical mode including project review meetings with COVID safety protocols.
| Conclusion|| |
The COVID-19 pandemic has significantly affected the research activities across the globe. While dealing with pandemic, research activities, particularly, non-COVID, were deemed nonessential by the administration. Recalibration of deliverables became a necessity. Resuming research activities amidst the pandemic took time due to the uncertainties and safety concerns. However, opportunities for new research also opened. Adaptability in study design, communication with ethics review board regarding deviations in protocol, multicentric collaborative study design, use of digital methods wherever possible, ensuring data safety, and robust and expedited peer review processes were some of the methods adapted by different researchers across the globe to continue quality research. The researchers can take this opportunity to explore the interaction between the pandemic and mental health. The periods of complete lockdown could be utilized for productive research activities like data analysis, manuscript writing, and modifying ongoing research protocols to make the best use of time and be prepared for future as the pandemic situation evolves. The experience of conducting research during the COVID-19 pandemic also helps in finding in innovative solutions to carry on research. The pandemic has taught the researchers efficient and cost-effective methods for conducting research while ensuring ethical conduct, safety, and data integrity.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun 2020;109:102433.
Flaxman S, Mishra S, Gandy A, Unwin HJ, Mellan TA, Coupland H, et al.
Estimating the effects of non-pharmaceutical interventions on COVID-19 in Europe. Nature 2020;584:257-61.
Mahmood S, Hasan K, Colder Carras M, Labrique A. Global preparedness against COVID-19: We must leverage the power of digital health. JMIR Public Health Surveill 2020;6:e18980.
Torales J, O'Higgins M, Castaldelli-Maia JM, Ventriglio A. The outbreak of COVID-19 coronavirus and its impact on global mental health. Int J Soc Psychiatry 2020;66:317-20.
Sharma MK, Anand N, Singh P, Vishwakarma A, Mondal I, Thakur PC, et al.
Researcher burnout: An overlooked aspect in mental health research in times of COVID-19. Asian J Psychiatr 2020;54:102367.
Ameen S, Praharaj SK. Problems in using WhatsApp groups for survey research. Indian J Psychiatry 2020;62:327-8. [Full text]
Sagar R, Chawla N, Sen MS. Preserving the “human touch” in times of COVID-19. Asian J Psychiatr 2020;54:102224.
Mehta UM, Venkatasubramanian G, Chandra PS. The “mind” behind the “mask”: Assessing mental states and creating therapeutic alliance amidst COVID-19. Schizophr Res 2020;222:503-4.
Hashem H, Abufaraj M, Tbakhi A, Sultan I. Obstacles and considerations related to clinical trial research during the COVID-19 pandemic. Front Med (Lausanne) 2020;7:598038.
Kar SK, Oyetunji TP, Prakash AJ, Ogunmola OA, Tripathy S, Lawal MM, et al.
Mental health research in the lower-middle-income countries of Africa and Asia during the COVID-19 pandemic: A scoping review. Neurol Psychiatry Brain Res 2020;38:54-64.
Guthrie S, Lichten CA, Van Belle J, Ball S, Knack A, Hofman J. Understanding mental health in the research environment: A rapid evidence assessment. Rand Health Q 2018;7:2.
Ma X, Wang Y, Gao T, He Q, He Y, Yue R, et al.
Challenges and strategies to research ethics in conducting COVID-19 research. J Evid Based Med 2020;13:173-7.
World Health Organization. Ethical Standards for Research during Public Health Emergencies: Distilling Existing Guidance to Support COVID-19 R&D. World Health Organization; 2020. Available from https://www.who.int/publications/i/item/WHO-RFH-20.1
. [Last accessed on 2021 Aug 21].
Xu S, Li Y. Global coalition to accelerate COVID-19 clinical research in resource-limited settings. Lancet 2020;395:1322-5.
Keshavan MS. Pandemics and psychiatry: Repositioning research in context of COVID-19. Asian J Psychiatr 2020;51:102159.
Padala PR, Jendro AM, Padala KP. Conducting clinical research during the COVID-19 pandemic: Investigator and participant perspectives. JMIR Public Health Surveill 2020;6:e18887.
Woolliscroft JO. Innovation in response to the COVID-19 pandemic crisis. Acad Med 2020;95:1140-2.
Tan AC, Ashley DM, Khasraw M. Adapting to a pandemic – Conducting oncology trials during the SARS-CoV-2 pandemic. Clin Cancer Res 2020;26:3100-3.
Wilbanks JT. Electronic informed consent in mobile applications research. J Law Med Ethics 2020;48:147-53.
Chen Q, Liang M, Li Y, Guo J, Fei D, Wang L, et al.
Mental health care for medical staff in China during the COVID-19 outbreak. Lancet Psychiatry 2020;7:e15-6.
Tandon R. The COVID-19 pandemic, personal reflections on editorial responsibility. Asian J Psychiatr 2020;50:102100.
Singh SP, Mohan M, Iyer SN, Meyer C, Currie G, Shah J, et al.
Warwick-India-Canada (WIC) global mental health group: Rationale, design and protocol. BMJ Open 2021;11:e046362.
Sood M, Ranjan R, Chadda RK, Khandelwal SK. Changing pattern of clinical profile of first-contact patients attending outpatient services at a general hospital psychiatric unit in India over the last 50 years. Indian J Soc Psychiatry 2017;33:213. [Full text]