Trial Review

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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
Date results information 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] 301694 0
None
Universal Trial Number (UTN)
U1111-1254-7316
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perceived stress 318139 0
Depression 318140 0
COVID-19 318491 0
Condition category
Condition code
Mental Health 316164 316164 0 0
Other mental health disorders
Mental Health 316165 316165 0 0
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] 318001 0
Treatment: Other
Comparator / control treatment
Control arm or Arm 2 will not receive any intervention.
Control group
Active

Outcomes
Primary outcome [1] 324345 0
Change in the level of perceived stress measured on the Perceived Stress Scale (PSS)
Timepoint [1] 324345 0
Immediately post-intervention in September 2020; and
Six months post-intervention in March 2021
Primary outcome [2] 324346 0
Change in the level of depression on the Centre for Epidemiological Studies Depression Scale version 10 (CESDS)
Timepoint [2] 324346 0
Immediately post-intervention in September 2020; and
Six months post-intervention in March 2021
Secondary outcome [1] 384400 0
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] 384400 0
Immediately post-intervention in September 2020; and
Six months post-intervention in March 2021
Secondary outcome [2] 385251 0
Change in the frequency of common ailment will be assessed using study-specific questionnaire base on self-report.
Timepoint [2] 385251 0
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?
No
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] 22715 0
Bangladesh
State/province [1] 22715 0
Khulna

Funding & Sponsors
Funding source category [1] 306131 0
Other
Name [1] 306131 0
Global Development and Research Initiative
Country [1] 306131 0
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] 306598 0
Individual
Name [1] 306598 0
Associate Professor Firoz Ahmed
Address [1] 306598 0
Department of Economics
Khulna University
Khulna – 9208, Bangladesh
Country [1] 306598 0
Bangladesh

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306349 0
Institutional Ethics Committee, Indian Institute of Technology Kanpur
Ethics committee address [1] 306349 0
Indian Institute of Technology Kanpur
Kalyanpur, Kanpur
Uttar Pradesh 208016,
India
Ethics committee country [1] 306349 0
India
Date submitted for ethics approval [1] 306349 0
07/07/2020
Approval date [1] 306349 0
15/07/2020
Ethics approval number [1] 306349 0
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 103570 0
Prof Asadul Islam
Address 103570 0
Caulfield Campus
Building H, Room 4.37, Sir John Monash Drive
Monash University
Caulfield East
Vic 3145, Australia
Country 103570 0
Australia
Phone 103570 0
+61 3 9903 2783
Fax 103570 0
+61 3 9903 1128
Email 103570 0
[email protected]
Contact person for public queries
Name 103571 0
Prof Asadul Islam
Address 103571 0
Caulfield Campus
Building H, Room 4.37, Sir John Monash Drive
Monash University
Caulfield East
Vic 3145, Australia
Country 103571 0
Australia
Phone 103571 0
+61 3 9903 2783
Fax 103571 0
+61 3 9903 1128
Email 103571 0
[email protected]
Contact person for scientific queries
Name 103572 0
Prof Asadul Islam
Address 103572 0
Caulfield Campus
Building H, Room 4.37, Sir John Monash Drive
Monash University
Caulfield East
Vic 3145, Australia
Country 103572 0
Australia
Phone 103572 0
+61 3 9903 2783
Fax 103572 0
+61 3 9903 1128
Email 103572 0
[email protected]

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 ([email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8400Statistical analysis plan  [email protected]



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.