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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Otago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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