ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000795998

Ethics application status

Approved

Date submitted

15/07/2020

Date registered

7/08/2020

Date last updated

7/08/2020

Date data sharing statement initially provided

7/08/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

COVID-19 Health and wellbeing Trial in Bangladesh

Scientific title

A Brief Telecounselling Intervention During COVID-19 for Women in Rural Bangladesh

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1254-7316

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Perceived stress

Depression

COVID-19

Condition category

Condition code

Mental Health

Other mental health disorders

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention, starting on 16 July 2020, consists of four brief mental-health counseling sessions over the phone (i.e., tele-counseling) to 2,402 women distributed across 357 villages in Khulna and Satkhira districts in Bangladesh. One adult woman per household was enrolled for the program. Following enrolment, we randomly assigned them to either the telecounseling treatment arm, Arm 1, or to the control arm, Arm 2, where no counseling is provided to women. Therefore, our randomization is at the household (or individual) level.
Eventually, 1,299 women were assigned to Arm 1 and 1,103 women to Arm 2. We are running four fortnightly (every two weeks) tele-counseling sessions, each for 20 minutes, covering different aspects of the coronavirus’ impact on women’s physical and emotional wellbeing. Thus, the intervention will be given over two months. The four informational modules (delivered via interactive sessions using study-specific materials) that are being covered are on: (i) awareness of COVID-19, symptoms and preventive measures to address the fear of infection; (ii) taking care of emotional wellbeing to cope with stress; (iii) taking care of physical health of self and child to address health-related anxiety; and, (iv) helping each other and staying connected to cope with social distancing.
Sessions are delivered by locally recruited, trained female para counsellors. Para counsellors contact participants a week before every session to make an appointment that is convenient for participants; they then talk to participants during the nominated time.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Control arm or Arm 2 will not receive any intervention.

Control group

Active

Outcomes

Primary outcome [1]

Change in the level of perceived stress measured on the Perceived Stress Scale (PSS)

Timepoint [1]

Immediately post-intervention in September 2020; and
Six months post-intervention in March 2021

Primary outcome [2]

Change in the level of depression on the Centre for Epidemiological Studies Depression Scale version 10 (CESDS)

Timepoint [2]

Immediately post-intervention in September 2020; and
Six months post-intervention in March 2021

Secondary outcome [1]

Change in compliance with COVID-19 precautionary measures assessed on the basis of self-report on practice data collected using questionnaire specific to this trial

Timepoint [1]

Immediately post-intervention in September 2020; and
Six months post-intervention in March 2021

Secondary outcome [2]

Change in the frequency of common ailment will be assessed using study-specific questionnaire base on self-report.

Timepoint [2]

Immediately post-intervention in September 2020; and
Six months post-intervention in March 2021

Eligibility

Key inclusion criteria

Female inhabitants of reproductive age group of study areas who have experienced moderate to severe food insecurity on Food Insecurity Experience Scale (FIES).

Minimum age

18 Years

Maximum age

49 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Male gender
Females aged below 18 years or over 49 years
Females not being able to give informed consent
Females not visiting relatives in the study area and not living there for the next 9 months
Females known to have any pre-existing mental health conditions

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created
by computer software

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

Actual

31/05/2020

Date of last participant enrolment

Anticipated

Actual

15/06/2020

Date of last data collection

Anticipated

31/03/2021

Actual

Sample size

Target

2402

Accrual to date

Final

2402

Recruitment outside Australia

Country [1]

Bangladesh

State/province [1]

Khulna

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Global Development and Research Initiative

Address [1]

66 Outer Circular Road
Boromoghbazar
Dhaka - 1217
Bangladesh

Country [1]

Bangladesh

Primary sponsor type

University

Name

Monash University

Address

Wellington Rd,
Clayton
VIC 3800
&
Caulfield Campus
900 Dandenong Rd
Caulfield East
VIC 3145

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Associate Professor Firoz Ahmed

Address [1]

Department of Economics
Khulna University
Khulna – 9208, Bangladesh

Country [1]

Bangladesh

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Institutional Ethics Committee, Indian Institute of Technology Kanpur

Ethics committee address [1]

Indian Institute of Technology Kanpur
Kalyanpur, Kanpur
Uttar Pradesh 208016, 
India

Ethics committee country [1]

India

Date submitted for ethics approval [1]

07/07/2020

Approval date [1]

15/07/2020

Ethics approval number [1]

IITK/IEC/2019-20-II/Jul/1

Summary

Brief summary

We will then provide telecounselling among half (1500) of these women to be selected randomly.  We will run four weekly telecounselling sessions, for 20 minutes, by female para-counsellor, each covering different aspects of COVID-19 effect on the women’s physical and emotional wellbeing. The modules are: (a) awareness of COVID-19, symptoms and preventive measures to address the fear of infection; (b) taking care of emotional wellbeing to cope with stress; (c) taking care of physical health of self and child to address health-related anxiety; and, (d) helping each other and staying connected to cope with isolation. We will assess the outcomes in September 2020 and again in Mar 2021. We expect that the intervention will change the level of perceived stress and level of depression among participants, change the frequency of experiencing common ailments, and change their compliance with COVID-19 precautionary measures.

Trial website

Trial related presentations / publications

Public notes

The baseline data have been collected by GDRI who are our local research partner in Bangladesh. The data were collected for different research and were shared the data with us. Please note that this data has been used as baseline data for this trial. As the survey was done for another study we are unable to change the date of participant recruitment. We found out that we could contribute to ameliorating the mental health situation in the study area. Therefore, our intervention (i.e. one-to-one telecounselling) starts on 16 July 2020. This is why we applied for and obtained the ethics approval at a later date and were unable to register the trial before baseline. This will also generate critical evidence to inform policymakers about this important area. GDRI is funding the trial with its own resources and the Monash University will ensure the methodological aspects of the study as a sponsor.

Contacts

Principal investigator

Name

Prof Asadul Islam

Address

Caulfield Campus
Building H, Room 4.37, Sir John Monash Drive
Monash University
Caulfield East
Vic 3145, Australia

Country

Australia

Phone

+61 3 9903 2783

Fax

+61 3 9903 1128

asadul.islam@monash.edu

Contact person for public queries

Name

Asadul Islam

Address

Caulfield Campus
Building H, Room 4.37, Sir John Monash Drive
Monash University
Caulfield East
Vic 3145, Australia

Country

Australia

Phone

+61 3 9903 2783

Fax

+61 3 9903 1128

asadul.islam@monash.edu

Contact person for scientific queries

Name

Asadul Islam

Address

Caulfield Campus
Building H, Room 4.37, Sir John Monash Drive
Monash University
Caulfield East
Vic 3145, Australia

Country

Australia

Phone

+61 3 9903 2783

Fax

+61 3 9903 1128

asadul.islam@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

De-identified data of published results only.

When will data be available (start and end dates)?

Immediately after publication, no date to be decided.

Available to whom?

Only researchers who provide a methodologically sound proposal, and case-by-case basis at the discretion of Primary Sponsor.

Available for what types of analyses?

Only to achieve the aims in the approved proposal.

How or where can data be obtained?

Access subject to approvals by Principal Investigator (asadul.islam@monash.edu).

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8400	Statistical analysis plan			asadul.islam@monash.edu

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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