Psychosocial ImpactsNCT05052333
Examine the Psychosocial Impacts of COVID-19 Pandemic.
An observational study of Psychosocial Impacts and COVID-19 Pandemic, run by University of Otago at 9 sites in 7 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychosocial Impacts, COVID-19 Pandemic
- How many people
- 2,574 participants
- Where
- 9 sitesin 7 countries
- Study dates
- 1 Dec 2021to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 7 countries.
9 sites in 7 countries
Indonesia2 sites
Universitas Ahmad Dahlan
Yogyakarta
Universitas Gadjah Mada
Yogyakarta
Iraq2 sites
Ibn Sina University of Medical and Pharmaceutical Sciences
Baghdad
Mustansiriyah University
Baghdad
United States1 site
University of Washington
Seattle, Washington, 98195-1525
About this study
Official title: 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.
- Conditions
- Psychosocial Impacts, COVID-19 Pandemic
- Keywords
- Psychological distress, Wellbeing, Mental health, Reliability and validity, Low and middle income countries, Cross-cultural comparisons
- Medical subject headings
- COVID-19, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Dec 2021
- Primary completion30 Sep 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Psychosocial ImpactsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,574 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Otago
- Sponsor type
- University, hospital or other
- Collaborators
- International Islamic University, Islamabad, Universitas Ahmad Dahlan, Gadjah Mada University, Ibn Sina University of Medical and Pharmaceutical Sciences, Iraq, Al-Mustansiriyah University, Hasan Kalyoncu University, University of Washington, University of Malaya, University of Social Welfare and Rehabilitation Science
- Responsible party
- Principal investigator, Sandila Tanveer, University of Otago
- Investigators
- Caroline Bell, MD, Principal investigator, University of Otago Christchurch, New ZealandSandila Tanveer, PhD, Principal investigator, University of Otago Christchurch, New ZealandRuqayya Sulaiman-Hill, PhD, Principal investigator, University of Otago Christchurch, New ZealandRichard Porter, MRCPsych, Study director, University of Otago Christchurch, New ZealandJoseph Boden, PhD, Principal investigator, University of Otago Christchurch, New ZealandBen Beaglehole, FRANZCP, Principal investigator, University of Otago Christchurch, New ZealandShaystah Dean, PhD, Principal investigator, University of Otago Wellington, New ZealandPhilip Schluter, PhD, Principal investigator, University of Canterbury, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052333
- Sponsor's protocol ID
- UOtago
- Status last verified
- Nov 2023
- First submitted
- 19 Sep 2021
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33645256Bell 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.
PubMed 34281926Fergusson 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.
PubMed 25430912Jenkins 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.
PubMed 33793672Kessler 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.
PubMed 12578436Tedeschi 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.
PubMed 28099764Topp 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.
PubMed 25831962Blevins 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.
PubMed 26606250Tanveer 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.
PubMed 37297593Tanveer 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.
PubMed 37045574Tanveer S, Schluter PJ, Porter RJ, Boden JM, Beaglehole B, Sulaiman-Hill R, Dean S, Al-Hussainni WN, Al-Masoodi MAM, Arshi M, Bentley JA, Dinc M, Feeny N, Ibrahim HJ, Ismail AM, Ismail AS, Khan MJ, Khoshnami MS, Kunle MA, Levine D, Moghanibashi-Mansourieh A, Moratz A, Nordin ASA, Noruzi S, Ozturk S, Rahajeng A, Shaikh S, Tanveer N, Topcu F, Yunianto I, Zoellner LA, Bell C. Comparing the psychosocial impacts of COVID-19 in seven low- and middle-income countries: A cross-sectional study. PLOS Glob Public Health. 2026 Jun 16;6(6):e0005944. doi: 10.1371/journal.pgph.0005944. eCollection 2026.
PubMed 42301996
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Study Examining the Psychosocial Impacts of COVID-19 Pandemic.
- ClinicalTrials.gov ID
- NCT05052333
- Acronym / sponsor ID
- UOtago
- Conditions
- Psychosocial Impacts, COVID-19 Pandemic
- Keywords
- Psychological distress, Wellbeing, Mental health, Reliability and validity, Low and middle income countries, Cross-cultural comparisons
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,574 participants (actual)
- Lead sponsor
- University of OtagoUniversity, hospital or other
- Collaborators
- International Islamic University, Islamabad, Universitas Ahmad Dahlan, Gadjah Mada University, Ibn Sina University of Medical and Pharmaceutical Sciences, Iraq, Al-Mustansiriyah University, Hasan Kalyoncu University, University of Washington, University of Malaya, University of Social Welfare and Rehabilitation Science
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Background: PubMed 33645256Bell 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.
- Background: PubMed 34281926Bell 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.
- Background: PubMed 25430912Fergusson 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.
- Background: PubMed 33793672Jenkins 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.
- Background: PubMed 12578436Kessler 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.
- Background: PubMed 28099764Tedeschi 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.
- Background: PubMed 25831962Topp 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.
- Background: PubMed 26606250Blevins 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.
- Background: PubMed 37297593Tanveer 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.
- Results publication: PubMed 37045574Tanveer 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.
- Derived from this study: PubMed 42301996Tanveer S, Schluter PJ, Porter RJ, Boden JM, Beaglehole B, Sulaiman-Hill R, Dean S, Al-Hussainni WN, Al-Masoodi MAM, Arshi M, Bentley JA, Dinc M, Feeny N, Ibrahim HJ, Ismail AM, Ismail AS, Khan MJ, Khoshnami MS, Kunle MA, Levine D, Moghanibashi-Mansourieh A, Moratz A, Nordin ASA, Noruzi S, Ozturk S, Rahajeng A, Shaikh S, Tanveer N, Topcu F, Yunianto I, Zoellner LA, Bell C. Comparing the psychosocial impacts of COVID-19 in seven low- and middle-income countries: A cross-sectional study. PLOS Glob Public Health. 2026 Jun 16;6(6):e0005944. doi: 10.1371/journal.pgph.0005944. eCollection 2026.
- World Health Organization (2021). Mental Health and Psychosocial Considerations During the COVID-19 Outbreak.Link provided by the sponsor.
- The Coronavirus Health Impact Survey (2019)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Bell, MD principal investigator
University of Otago Christchurch, New Zealand
Sandila Tanveer, PhD principal investigator
University of Otago Christchurch, New Zealand
Ruqayya Sulaiman-Hill, PhD principal investigator
University of Otago Christchurch, New Zealand
9 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosocial Impacts and COVID-19 Pandemic, run by University of Otago at 9 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Indonesia, Iraq, United States, Iran, Malaysia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05052333, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.