Examine the Psychosocial Impacts of Covid-19 Pandemic.

Sponsor

University of Otago (Other)

Overall Status

Recruiting

CT.gov ID

NCT05052333

Collaborator

International Islamic University, Islamabad (Other), Universitas Ahmad Dahlan (Other), Gadjah Mada University (Other), Ibn Sina University of Medical and Pharmaceutical Sciences, Iraq (Other), Al-Mustansiriyah University (Other), Hasan Kalyoncu University (Other), University of Washington (Other), University of Malaya (Other)

4,000

Enrollment

Locations

Anticipated Duration (Months)

444.4

Patients Per Site

17.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an observational study examining the psychosocial impacts of the COVID-19 pandemic in seven low-and-middle income countries (Bangladesh, Indonesia, Iraq, Malaysia, Pakistan, Somalia, and Turkey). The data will be obtained on the measures of wellbeing (WHO Well-Being Index), psychological distress (Kessler 10), post-traumatic stress (PTSD Checklist for DSM-5), post-traumatic growth (Posttraumatic Growth Inventory), and pandemic-related stress (Covid Psychosocial Impacts Scale). Depending on the context, the data will be collected employing either a unilingual (in native language) or bilingual online survey (with English as a second language) from 500 participants (aged 18 and above) in each of the seven locations using non-probability convenient sampling. Where applicable in some countries (Malaysia, Somalia, Turkey), a follow-up survey will be repeated in the same cohort, which will provide a comparable data set longitudinally. The findings will enable us to examine the psychosocial impacts of COVID-19; validate the translations of the CPIS and standardized measures; and determine the trajectory of study variables with pandemic exposure.

Condition or Disease	Intervention/Treatment	Phase
Psychosocial Stressor Covid19

Study Design

Study Type:

Observational

Anticipated Enrollment :

4000 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

An International Study Examining the Psychosocial Impacts of Covid-19 Pandemic.

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Examining the psychosocial impacts of Covid-19 in Pakistan. This is exploratory research and data will be obtained on a set of measures (N=500) using a one-off bilingual (Urdu-English) survey. No predefined conditions apply to explain the nature of the study group other than inclusion and exclusion criteria.
Examining the psychosocial impacts of Covid-19 in Iraq. This is exploratory research and data will be obtained on a set of measures (N=500) using a one-off bilingual (Arabic-English) survey. No predefined conditions apply to explain the nature of the study group other than inclusion and exclusion criteria.
Examining the psychosocial impacts of Covid-19 in Turkey. This is exploratory research and data will be obtained on a set of measures (N=500) using a unilingual (Turkish) survey with longitudinal assessment after 12 months of the initial assessment. No predefined conditions apply to explain the nature of the study group other than inclusion and exclusion criteria.
Examining the psychosocial impacts of Covid-19 in Bangladesh. This is exploratory research and data will be obtained on a set of measures (N=500) using a one-off unilingual (Bangla) survey. No predefined conditions apply to explain the nature of the study group other than inclusion and exclusion criteria.
Examining the psychosocial impacts of Covid-19 in Malaysia. This is exploratory research and data will be obtained on a set of measures (N=500) using a bilingual (Malay-English) survey. Data will be obtained longitudinally after 12 months of initial assessment. No predefined conditions apply to explain the nature of the study group other than inclusion and exclusion criteria.
Examining the psychosocial impacts of Covid-19 in Indonesia. This is exploratory research and data will be obtained on a set of measures (N=500) using a one-off unilingual (Indonesian) survey. No predefined conditions apply to explain the nature of the study group other than inclusion and exclusion criteria.
Examining the psychosocial impacts of Covid-19 in Somalia. This is exploratory research and data will be obtained on a set of measures (N=500) using a one-off bilingual (Somalia-English) longitudinally. No predefined conditions apply to explain the nature of the study group other than inclusion and exclusion criteria.

Outcome Measures

Primary Outcome Measures

Examining the psychosocial impacts of the COVID-19 pandemic. [The time it takes to perform the initial assessment varies, but it usually takes about 9 months. The follow-up longitudinal assessments (Malaysia, Somalia, Turkey) will take an average of two years to complete once the study is completed.]
To explore the psychosocial impacts of the Covid-19 pandemic on self-report questionnaires of wellbeing (WHO-5), psychological distress (K10), post-traumatic stress (PCL-5), post-traumatic growth (PTGI), and pandemic-related stress (CPIS) in several low-resource countries. The data will be collected employing a unilingual (Bangladesh, Indonesia, Turkey) or bilingual (Iraq, Malaysia, Pakistan, Somalia) survey. Where applicable, a follow-up survey will be repeated longitudinally (Malaysia, Somalia, Turkey). With-in-subjects and between-subjects designs together with exploratory regression analyses will be employed to characterize this outcome.

Other Outcome Measures

Analyzing the psychometric properties of the translations of the newly developed CPIS and other standardized measures. [The time it takes to perform the initial assessment varies, but it usually takes about 9 months. The follow-up longitudinal assessments (Malaysia, Turkey, Somalia) will take an average of two years to complete.]
The findings will give psychometric information on the translations and suitability of use of the newly developed CPIS and other standardized questionnaires (K10, WHO-5, PCL-5, PTGI) in several low-resource countries. The findings will help determine the quality of translations and their appropriateness for usage in the target population. The data will be collected employing a unilingual (Bangladesh, Indonesia, Turkey) or bilingual (Iraq, Malaysia, Pakistan, Somalia) survey. Where applicable, a follow-up survey will be repeated longitudinally (Malaysia, Somalia, Turkey). The metric used to characterize this outcome involves reliability (internal consistency, test-retest reliability) and validity (convergent, discriminant) analyses.
Analyzing the longitudinal trajectory of the psychosocial impacts of the Covid-19 pandemic. [The time to complete the study can vary but it will be completed in an average of 2 years.]
The data will be obtained longitudinally in some countries to understand the trajectory of psychosocial impacts and to examine the degree of changes over time. The data will be collected employing a unilingual (Turkey) or bilingual (Malaysia, Somalia) survey and it will comprise of several self-report questionnaires of wellbeing (WHO-5), psychological distress (K10), post-traumatic stress (PCL-5), post-traumatic growth (PTGI), and newly developed measures of pandemic-related stress (CPIS). A follow-up survey will be repeated longitudinally in the same cohort. The metric used to characterize this outcome involves tabular and graphical measures and the use of linear mixed model analysis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Aged 18 and above
Currently residing in the country of interest.
Additional inclusion criterion applies to bilingual studies; which is having English as a second language.

Exclusion Criteria:

Aged below 18 years.
Not residing in the country of interest.
Additional exclusion criterion applies to bilingual studies; which is not having English as a second language.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington	Seattle	Washington	United States	98195-1525
2	Universitas Ahmad Dahlan	Yogyakarta		Indonesia
3	Universitas Gadjah Mada	Yogyakarta		Indonesia
4	Ibn Sina University of Medical and Pharmaceutical Sciences	Baghdad		Iraq
5	Mustansiriyah University	Baghdad		Iraq
6	Universiti Malaya	Kuala Lumpur		Malaysia
7	International Islamic University	Islamabad		Pakistan	44000
8	Quaid-i-Azam University	Islamabad		Pakistan	44000
9	Hasan Kalyoncu Üniversitesi	Gaziantep		Turkey

Sponsors and Collaborators

University of Otago
International Islamic University, Islamabad
Universitas Ahmad Dahlan
Gadjah Mada University
Ibn Sina University of Medical and Pharmaceutical Sciences, Iraq
Al-Mustansiriyah University
Hasan Kalyoncu University
University of Washington
University of Malaya

Investigators

Principal Investigator: Caroline Bell, MD, University of Otago Christchurch, New Zealand
Principal Investigator: Sandila Tanveer, PhD, University of Otago Christchurch, New Zealand
Principal Investigator: Ruqayya Sulaiman-Hill, PhD, University of Otago Christchurch, New Zealand
Study Director: Richard Porter, MRCPsych, University of Otago Christchurch, New Zealand
Principal Investigator: Joseph Boden, PhD, University of Otago Christchurch, New Zealand
Principal Investigator: Ben Beaglehole, FRANZCP, University of Otago Christchurch, New Zealand
Principal Investigator: Shaystah Dean, PhD, University of Otago Wellington, New Zealand
Principal Investigator: Philip Schluter, PhD, University of Canterbury, New Zealand