Investigating the impact of COVID-19 and its response, on people with severe mental illness in South Asia
| ISRCTN | ISRCTN15571919 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15571919 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University of York |
| Funder | National Institute of Health Research |
- Submission date
- 25/05/2020
- Registration date
- 28/05/2020
- Last edited
- 28/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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, g.zavala@york.ac.uk
Contact information
Scientific
University of York
Heslington
York
YO10 5DD
United Kingdom
 ORCID ID |
0000-0002-9825-8725 |
|---|---|
| Phone | +44 (0)1904 321333 |
| g.zavala@york.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Longitudinal study |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | Investigating the impact of COVID-19 and its response, on people with severe mental illness in South Asia |
| Study acronym | IMPACT SMI-COVID-19 Survey |
| Study objectives | People with severe mental illness are more likely to be affected by the COVID-19 pandemic than people without severe mental illness |
| Ethics approval(s) | 1. Approved 29/04/2020, Health Sciences Research Governance Committee from the University of York (Heslington, York, YO10 5DD, UK; +44 (0)1904 323253; smh12@york.ac.uk), 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; info@ciprb.org), 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; drgrimaji@gmail.com), 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; info@rmur.edu.pk), ref: n/a |
| Health condition(s) or problem(s) studied | Severe mental illness |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
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) |
| Key secondary outcome measure(s) |
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 |
| Completion date | 01/02/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 2000 |
| Key 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. |
| Key exclusion criteria | Lack of capacity |
| Date of first enrolment | 05/05/2020 |
| Date of final enrolment | 01/01/2022 |
Locations
Countries of recruitment
- Bangladesh
- India
- Pakistan
Study participating centres
Dhaka
N/A
Bangladesh
Chah Sultan
Punjab
Rawalpindi
46000
Pakistan
Someshwara Nagar
Jayanagar
Karnataka
Bangaluru
560029
India
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/05/2020: Trial’s existence confirmed by University of York
