Examine the Psychosocial Impacts of COVID-19 Pandemic.

November 30, 2023 updated by: Sandila Tanveer, University of Otago

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

This is an observational study examining the psychosocial impacts of the COVID-19 pandemic in seven low-and-middle income countries (Indonesia, Iran, Iraq, Malaysia, Pakistan, Somaliland, and Turkiye). The data was obtained on standardised 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 a novel pandemic-related stress (COVID Psychosocial Impacts Scale). Data was collected employing either a unilingual (in native language) or bilingual online survey (with English as a second language) from participants (N=2574) aged 18 and above using a non-probability convenient sampling. The findings enabled 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2574

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Yogyakarta, Indonesia
        • Universitas Ahmad Dahlan
      • Yogyakarta, Indonesia
        • Universitas Gadjah Mada
  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • University of Social Welfare and Rehabilitation Sciences
  • Iraq
      • Baghdad, Iraq
        • Ibn Sina University of Medical and Pharmaceutical Sciences
      • Baghdad, Iraq
        • Mustansiriyah University
  • Malaysia
      • Kuala Lumpur, Malaysia
        • universiti malaya
  • Pakistan
      • Islamabad, Pakistan, 44000
        • International Islamic University
  • Turkey
      • Gaziantep, Turkey
        • Hasan Kalyoncu Üniversitesi
  • United States
    • Washington
      • Seattle, Washington, United States, 98195-1525
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The participants will be recruited from the general population using convenience sampling in each of the seven locations (Indonesia, Iran, Iraq, Malaysia, Pakistan, Somaliland, and Turkiye). The specific details (e.g., residents of a certain town) may vary from country to country and it will be outlined by the international collaborators in local ethics applications.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Examining the psychosocial impacts of COVID-19 in Pakistan.
This is exploratory research and data will be obtained on a set of measures using a 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 using a 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 Türkiye.
This is exploratory research and data will be obtained on a set of measures using a unilingual (Turkish) 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 Iran.
This is exploratory research and data will be obtained on a set of measures using a Bilingual (Persian-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 Malaysia.
This is exploratory research and data will be obtained on a set of measures using a bilingual (Malay-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 Indonesia.
This is exploratory research and data will be obtained on a set of measures using a 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 Somaliland.
This is exploratory research and data will be obtained on a set of measures using a unilingual (Somalia) survey. No predefined conditions apply to explain the nature of the study group other than inclusion and exclusion criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examining the psychosocial impacts of the COVID-19 pandemic.
Time Frame: Data was collected in a short-time window on each site. The time of data collection varies across site and was collected from Dec 2021 to Sep 2023.
To explore the psychosocial impacts of the COVID-19 pandemic on self-report measures of wellbeing (WHO-5), psychological distress (K10), post-traumatic stress (PCL-5), post-traumatic growth (PTGI), and pandemic-related stress (CPIS) in seven LMICs. The data will be collected employing a unilingual (Indonesia, Somaliland, Turkey) or bilingual (Iran, Iraq, Malaysia, Pakistan) survey. With-in-subjects and between-subjects designs together with exploratory regression analyses will be employed to characterize this outcome.
Data was collected in a short-time window on each site. The time of data collection varies across site and was collected from Dec 2021 to Sep 2023.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analyzing the psychometric properties of the translations of the newly developed CPIS and other standardized measures.
Time Frame: The time of data collection varies across site and was collected from Dec 2021 to Sep 2023.
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 seven LMICs. The metric used to characterize this outcome involves reliability (internal consistency) and validity (construct) analyses.
The time of data collection varies across site and was collected from Dec 2021 to Sep 2023.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Otago

Collaborators

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

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

September 19, 2021

First Submitted That Met QC Criteria

September 20, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOtago

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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