Condition category
Mental and Behavioural Disorders
Date applied
25/05/2020
Date assigned
28/05/2020
Last edited
28/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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, g.zavala@york.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gerardo Zavala

ORCID ID

http://orcid.org/0000-0002-9825-8725

Contact details

University of York
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 321333
g.zavala@york.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Investigating the impact of COVID-19 and its response, on people with severe mental illness in South Asia

Acronym

IMPACT SMI-COVID-19 Survey

Study hypothesis

People with severe mental illness are more likely to be affected by the COVID-19 pandemic than people without severe mental illness

Ethics approval

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

Study design

Longitudinal study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Home

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

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

10/04/2020

Overall trial end date

01/02/2022

Reason abandoned (if study stopped)

Eligibility

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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2,000

Participant exclusion criteria

Lack of capacity

Recruitment start date

05/05/2020

Recruitment end date

01/01/2022

Locations

Countries of recruitment

Bangladesh, India, Pakistan

Trial participating centre

National Institute of Mental Health and Hospital
Dhaka 1207
Dhaka
N/A
Bangladesh

Trial participating centre

Institute of Psychiatry
Benazir Bhutto Rd Chah Sultan Punjab
Rawalpindi
46000
Pakistan

Trial participating centre

National Institute of Mental Health and Neuro-Sciences
368, 8th Main Rd, 2nd Block Someshwara Nagar, Jayanagar Karnataka
Bangaluru
560029
India

Sponsor information

Organisation

University of York

Sponsor details

Heslington
York
YO10 5DD
United Kingdom
+44 (0) 1904 320 000
inquiries@York.ac.uk

Sponsor type

University/education

Website

https://www.york.ac.uk/

Funders

Funder type

Government

Funder name

National Institute of Health Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

01/09/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

28/05/2020: Trial’s existence confirmed by University of York