Examine the Psychosocial Impacts of COVID-19 Pandemic.

COVID-19 Pandemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05052333
• Other study ID #: UOtago
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: University of Otago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2574
• Est. completion date: October 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic

Locations

Country	Name	City	State
Indonesia	Universitas Ahmad Dahlan	Yogyakarta
Indonesia	Universitas Gadjah Mada	Yogyakarta
Iran, Islamic Republic of	University of Social Welfare and Rehabilitation Sciences	Tehran
Iraq	Ibn Sina University of Medical and Pharmaceutical Sciences	Baghdad
Iraq	Mustansiriyah University	Baghdad
Malaysia	Universiti Malaya	Kuala Lumpur
Pakistan	International Islamic University	Islamabad
Turkey	Hasan Kalyoncu Üniversitesi	Gaziantep
United States	University of Washington	Seattle	Washington

Sponsors (10)

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

Countries where clinical trial is conducted

United States,  Indonesia,  Iran, Islamic Republic of,  Iraq,  Malaysia,  Pakistan,  Turkey, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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, — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Analyzing the psychometric properties of the translations of the newly developed CPIS and other standardized measures.	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.
Primary	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.

External Links

•   The Coronavirus Health Impact Survey (2019)
•   World Health Organization (2021). Mental Health and Psychosocial Considerations During the COVID-19 Outbreak.