NCT05052333

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,574

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
6 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

September 19, 2021

Last Update Submit

November 30, 2023

Conditions

Keywords

Psychological distressWellbeingMental healthReliability and validityLow and middle income countriesCross-cultural comparisons

Outcome Measures

Primary Outcomes (1)

  • Examining the psychosocial impacts of the COVID-19 pandemic.

    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 Outcomes (1)

  • Analyzing the psychometric properties of the translations of the newly developed CPIS and other standardized measures.

    The time of data collection varies across site and was collected from Dec 2021 to Sep 2023.

Study Arms (7)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Aged 18 and above
  • Currently residing in the country of interest.

You may not qualify if:

  • Aged below 18 years.
  • Not residing in the country of interest.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of Washington

Seattle, Washington, 98195-1525, United States

Location

Universitas Ahmad Dahlan

Yogyakarta, Indonesia

Location

Universitas Gadjah Mada

Yogyakarta, Indonesia

Location

University of Social Welfare and Rehabilitation Sciences

Tehran, Iran

Location

Ibn Sina University of Medical and Pharmaceutical Sciences

Baghdad, Iraq

Location

Mustansiriyah University

Baghdad, Iraq

Location

Universiti Malaya

Kuala Lumpur, Malaysia

Location

International Islamic University

Islamabad, 44000, Pakistan

Location

Hasan Kalyoncu Üniversitesi

Gaziantep, Turkey (Türkiye)

Location

Related Publications (10)

  • Bell C, Beaglehole B, Bell R, Tanveer S, Sulaiman-Hill R, Boden J, Porter R. Learning from previous disasters: Potential pitfalls of epidemiological psychosocial research in the COVID-19 environment. Aust N Z J Psychiatry. 2021 Jul;55(7):646-649. doi: 10.1177/0004867421998783. Epub 2021 Mar 1.

    PMID: 33645256BACKGROUND
  • Bell C, Williman J, Beaglehole B, Stanley J, Jenkins M, Gendall P, Rapsey C, Every-Palmer S. Challenges facing essential workers: a cross-sectional survey of the subjective mental health and well-being of New Zealand healthcare and 'other' essential workers during the COVID-19 lockdown. BMJ Open. 2021 Jul 19;11(7):e048107. doi: 10.1136/bmjopen-2020-048107.

    PMID: 34281926BACKGROUND
  • Fergusson DM, Boden JM, Horwood LJ, Mulder RT. Perceptions of distress and positive consequences following exposure to a major disaster amongst a well-studied cohort. Aust N Z J Psychiatry. 2015 Apr;49(4):351-9. doi: 10.1177/0004867414560652. Epub 2014 Nov 27.

    PMID: 25430912BACKGROUND
  • Jenkins M, Hoek J, Jenkin G, Gendall P, Stanley J, Beaglehole B, Bell C, Rapsey C, Every-Palmer S. Silver linings of the COVID-19 lockdown in New Zealand. PLoS One. 2021 Apr 1;16(4):e0249678. doi: 10.1371/journal.pone.0249678. eCollection 2021.

    PMID: 33793672BACKGROUND
  • Kessler RC, Barker PR, Colpe LJ, Epstein JF, Gfroerer JC, Hiripi E, Howes MJ, Normand SL, Manderscheid RW, Walters EE, Zaslavsky AM. Screening for serious mental illness in the general population. Arch Gen Psychiatry. 2003 Feb;60(2):184-9. doi: 10.1001/archpsyc.60.2.184.

    PMID: 12578436BACKGROUND
  • Tedeschi RG, Cann A, Taku K, Senol-Durak E, Calhoun LG. The Posttraumatic Growth Inventory: A Revision Integrating Existential and Spiritual Change. J Trauma Stress. 2017 Feb;30(1):11-18. doi: 10.1002/jts.22155. Epub 2017 Jan 18.

    PMID: 28099764BACKGROUND
  • Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.

    PMID: 25831962BACKGROUND
  • Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.

    PMID: 26606250BACKGROUND
  • Tanveer S, Schluter PJ, Beaglehole B, Porter RJ, Boden J, Sulaiman-Hill R, Scarf D, Dean S, Assad F, Hasnat MA, Bell C. The COVID Psychosocial Impacts Scale: A Reliable and Valid Tool to Examine the Psychosocial Impacts of the COVID-19 Pandemic. Int J Environ Res Public Health. 2023 May 29;20(11):5990. doi: 10.3390/ijerph20115990.

    PMID: 37297593BACKGROUND
  • Tanveer S, Schluter PJ, Porter RJ, Boden J, Beaglehole B, Sulaiman-Hill R, Dean S, Bell R, Al-Hussainni WN, Arshi M, Amer Nordin AS, Dinc M, Khan MJ, Khoshnami MS, Majid Al-Masoodi MA, Moghanibashi-Mansourieh A, Noruzi S, Rahajeng A, Shaikh S, Tanveer N, Topcu F, Yapan S, Yunianto I, Zoellner LA, Bell C. Examining the psychosocial impacts of the COVID-19 pandemic: an international cross-sectional study protocol. BMJ Open. 2023 Apr 12;13(4):e067886. doi: 10.1136/bmjopen-2022-067886.

Related Links

MeSH Terms

Conditions

COVID-19Psychological Well-Being

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPersonal SatisfactionBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
  • Richard Porter, MRCPsych

    University of Otago Christchurch, New Zealand

    STUDY DIRECTOR
  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Research Fellow

Study Record Dates

First Submitted

September 19, 2021

First Posted

September 22, 2021

Study Start

December 1, 2021

Primary Completion

September 30, 2023

Study Completion

October 31, 2023

Last Updated

December 6, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations