Clinical trial NCT05052333: Examine the Psychosocial Impacts of COVID-19 Pandemic.
Official title: An International Study Examining the Psychosocial Impacts of COVID-19 Pandemic.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychosocial Impacts
COVID-19 Pandemic
Keywords: Psychological distress
Wellbeing
Mental health
Reliability and validity
Low and middle income countries
Cross-cultural comparisons
Lead sponsor: University of Otago
Sponsor class: OTHER
Collaborators: name: International Islamic University, Islamabad
name: Universitas Ahmad Dahlan
name: Gadjah Mada University
name: Ibn Sina University of Medical and Pharmaceutical Sciences, Iraq
name: Al-Mustansiriyah University
name: Hasan Kalyoncu University
name: University of Washington
name: University of Malaya
name: University of Social Welfare and Rehabilitation Sciences, Tehran, Iran
First posted: 2021-09-22
Enrollment: 2574
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Examining the psychosocial impacts of the COVID-19 pandemic.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
measure: Analyzing the psychometric properties of the translations of the newly developed CPIS and other standardized measures.
timeFrame: The time of data collection varies across site and was collected from Dec 2021 to Sep 2023.
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Yogyakarta
country: Indonesia
facility: Universitas Ahmad Dahlan
city: Yogyakarta
country: Indonesia
facility: Universitas Gadjah Mada
city: Tehran
country: Iran, Islamic Republic of
facility: University of Social Welfare and Rehabilitation Sciences
city: Baghdad
country: Iraq
facility: Ibn Sina University of Medical and Pharmaceutical Sciences
city: Baghdad
country: Iraq
facility: Mustansiriyah University
city: Kuala Lumpur
country: Malaysia
facility: Universiti Malaya
city: Islamabad
country: Pakistan
facility: International Islamic University
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu Üniversitesi
Study officials:
affiliation: University of Otago Christchurch, New Zealand
name: Caroline Bell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Otago Christchurch, New Zealand
name: Sandila Tanveer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Otago Christchurch, New Zealand
name: Ruqayya Sulaiman-Hill, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Otago Christchurch, New Zealand
name: Richard Porter, MRCPsych
role: STUDY_DIRECTOR
affiliation: University of Otago Christchurch, New Zealand
name: Joseph Boden, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Otago Christchurch, New Zealand
name: Ben Beaglehole, FRANZCP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Otago Wellington, New Zealand
name: Shaystah Dean, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Canterbury, New Zealand
name: Philip Schluter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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, 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.