Plain English Summary
Background and study aims
The current global COVID-19 pandemic has affected almost all aspects of life for a large proportion of the world’s population, including people living in low- and middle-income (LMIC) countries in South Asia. In preparing a response to the pandemic, it is important that the needs of vulnerable groups, such as people with severe mental illness (SMI; i.e. disorders such as schizophrenia, bipolar disorder) are not neglected to avoid widening existing health and healthcare inequalities. There are reasons to suggest people with SMI may be disproportionately affected by the outbreak and/or its response.
The aim of the study is to investigate the impact of the COVID-19 pandemic and its response (e.g. health promotion messaging, lockdown and social distancing) on persons with SMI.
Who can participate?
Adults with SMI.
What does the study involve?
Researchers will administer the survey by telephone and record responses directly using a tablet or PC. We will collect information about participants’ knowledge, attitudes and responses to public health measures to prevent COVID-19; symptoms, symptoms, diagnosis and testing for COVID-19 amongst participants and their families; participants’ wellbeing and mental health, health risk behaviours, quality of life and access to healthcare; and their housing (including urban/rural location), employment, finances, food security and social support.
What are the possible benefits and risks of participating?
The participants will be remunerated for their time, they will receive calling credit for their cell-phones. The procedures are not invasive and we don’t expect any harm to the participants however, If a subject during the interview reveals symptoms of COVID-19 or self-harm, the interviewer will report the findings to the PI, so the patient can be referred to a clinician for risk assessment and further management, according to protocols in place in each site.
Where is the study run from?
University of York (UK) and mental health hospitals in India, Pakistan, and Bangladesh.
When is the study starting and how long is it expected to run for?
May 2020 to February 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Gerardo Zavala, email@example.com
Investigating the impact of COVID-19 and its response, on people with severe mental illness in South Asia
IMPACT SMI-COVID-19 Survey
People with severe mental illness are more likely to be affected by the COVID-19 pandemic than people without severe mental illness
1. Approved 29/04/2020, Health Sciences Research Governance Committee from the University of York (Heslington, York, YO10 5DD, UK; +44 (0)1904 323253; firstname.lastname@example.org), ref: n/a
2. Approved 27/04/2020, National Centre for Injury Prevention and Rehabilitation Bangladesh (House: B 162, Rd No 23, Dhaka, Bangladesh; +880 2-6995004; email@example.com), ref: n/a
3. Approved, National Institute of Mental Health and Neurosciences ethics committee (P.O. Box No. 2900, Hosur Road, Bangaluru – 560 029, India; 91-11-26588980; firstname.lastname@example.org), ref: n/a
4. Approved 19/09/2018, National Bioethics Committee Pakistan (Institutional research and ethics forum, Rawalpindi medical university, Tipu Rd, Chamanzar Colony, Rawalpindi, Punjab 46000, Pakistan; +92 51 9290755; email@example.com), ref: n/a
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Severe mental illness
We will contact IMPACT SMI survey participants who have provided consent to contact will be contacted by telephone (n=2,500). Verbal informed consent will be obtained. Researchers will administer the survey by telephone and record responses directly using a tablet or PC. We will collect information about participants’ knowledge, attitudes and responses to public health measures to prevent COVID-19; symptoms, symptoms, diagnosis and testing for COVID-19 amongst participants and their families; participants’ wellbeing and mental health, health risk behaviours, quality of life and access to healthcare; and their housing (including urban/rural location), employment, finances, food security and social support.
Primary outcome measure
Depression, anxiety and wellbeing are measured via a telephone survey using the validated GAD7, PHQ9, and WEMWBS scales at baseline and possible follow-ups (depending on the evolution of the pandemic)
Secondary outcome measures
Beliefs and knowledge about COVID-19, Knowledge of, and response to government measures and public health advice to prevent the spread of COVID-19, Key sources and levels of trust for information about COVID-19, COVID-19 symptoms, Access to treatment for COVID-19, access to food, Problems with employment, income and finances, Social isolation, loneliness and limited social support will be measured via a telephone survey at a single time point
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Consenting adults aged 18 years and above with severe mental illness (schizophrenia, bipolar disorder, schizoaffective disorder and depression with psychotic symptoms) from the IMPACT survey. The IMPACT survey randomly selected and recruited eligible patients attending a mental health institute in Dhaka, Rawalpindi or Bangalore.
Target number of participants
Participant exclusion criteria
Lack of capacity
Recruitment start date
Recruitment end date
Countries of recruitment
Bangladesh, India, Pakistan
Trial participating centre
National Institute of Mental Health and Hospital
Trial participating centre
Institute of Psychiatry
Benazir Bhutto Rd Chah Sultan Punjab
Trial participating centre
National Institute of Mental Health and Neuro-Sciences
368, 8th Main Rd, 2nd Block Someshwara Nagar, Jayanagar Karnataka
National Institute of Health Research
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
As timely information is needed for policy and healthcare planning, we will prepare summaries and policy briefs as soon as possible after each wave of data collection, and share these with relevant policy makers (who are also collaborators in the IMPACT programme), professional bodies (e.g. Pakistan Psychiatric Society), those responsible for planning and management of health and social care and non-government organisations providing support to vulnerable populations. Lay summaries will also be prepared and disseminated via channels such as press releases and websites. This will be in addition to academic journal publications and conference presentations.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
Intention to publish date
Participant level data
Available on request
Basic results (scientific)