Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-01-06 @ 9:02 AM
Study NCT ID:
NCT05052333
Status:
COMPLETED
Last Update Posted:
2023-12-06
First Post:
2021-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examine the Psychosocial Impacts of COVID-19 Pandemic.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2574}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2021-09-19', 'studyFirstSubmitQcDate': '2021-09-20', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'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.', 'description': '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.'}], 'primaryOutcomes': [{'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.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychological distress', 'Wellbeing', 'Mental health', 'Reliability and validity', 'Low and middle income countries', 'Cross-cultural comparisons'], 'conditions': ['Psychosocial Impacts', 'COVID-19 Pandemic']}, 'referencesModule': {'references': [{'pmid': '33645256', 'type': 'BACKGROUND', '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.'}, {'pmid': '34281926', 'type': 'BACKGROUND', '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."}, {'pmid': '25430912', 'type': 'BACKGROUND', '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.'}, {'pmid': '33793672', 'type': 'BACKGROUND', '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.'}, {'pmid': '12578436', 'type': 'BACKGROUND', '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.'}, {'pmid': '28099764', 'type': 'BACKGROUND', '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.'}, {'pmid': '25831962', 'type': 'BACKGROUND', '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.'}, {'pmid': '26606250', 'type': 'BACKGROUND', '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.'}, {'pmid': '37297593', 'type': 'BACKGROUND', '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.'}, {'pmid': '37045574', 'type': 'RESULT', '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.'}], 'seeAlsoLinks': [{'url': 'https://apps.who.int/iris/handle/10665/331490', 'label': 'World Health Organization (2021). Mental Health and Psychosocial Considerations During the COVID-19 Outbreak.'}, {'url': 'http://www.crisissurvey.org/', 'label': 'The Coronavirus Health Impact Survey (2019)'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 and above\n* Currently residing in the country of interest.\n* Additional inclusion criterion applies to bilingual studies; which is having English as a second language.\n\nExclusion Criteria:\n\n* Aged below 18 years.\n* Not residing in the country of interest.\n* Additional exclusion criterion applies to bilingual studies; which is not having English as a second language.'}, 'identificationModule': {'nctId': 'NCT05052333', 'briefTitle': 'Examine the Psychosocial Impacts of COVID-19 Pandemic.', 'organization': {'class': 'OTHER', 'fullName': 'University of Otago'}, 'officialTitle': 'An International Study Examining the Psychosocial Impacts of COVID-19 Pandemic.', 'orgStudyIdInfo': {'id': 'UOtago'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Examining the psychosocial impacts of COVID-19 in Pakistan.', 'description': '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.'}, {'label': 'Examining the psychosocial impacts of COVID-19 in Iraq.', 'description': '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.'}, {'label': 'Examining the psychosocial impacts of COVID-19 in Türkiye.', 'description': '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.'}, {'label': 'Examining the psychosocial impacts of COVID-19 in Iran.', 'description': '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.'}, {'label': 'Examining the psychosocial impacts of COVID-19 in Malaysia.', 'description': '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.'}, {'label': 'Examining the psychosocial impacts of COVID-19 in Indonesia.', 'description': '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.'}, {'label': 'Examining the psychosocial impacts of Covid-19 in Somaliland.', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195-1525', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Yogyakarta', 'country': 'Indonesia', 'facility': 'Universitas Ahmad Dahlan', 'geoPoint': {'lat': -7.80139, 'lon': 110.36472}}, {'city': 'Yogyakarta', 'country': 'Indonesia', 'facility': 'Universitas Gadjah Mada', 'geoPoint': {'lat': -7.80139, 'lon': 110.36472}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'University of Social Welfare and Rehabilitation Sciences', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Baghdad', 'country': 'Iraq', 'facility': 'Ibn Sina University of Medical and Pharmaceutical Sciences', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}, {'city': 'Baghdad', 'country': 'Iraq', 'facility': 'Mustansiriyah University', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Universiti Malaya', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'zip': '44000', 'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'International Islamic University', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}, {'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Hasan Kalyoncu Üniversitesi', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}], 'overallOfficials': [{'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 Christchurch, New Zealand'}, {'name': 'Shaystah Dean, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Otago Wellington, New Zealand'}, {'name': 'Philip Schluter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Canterbury, New Zealand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Otago', 'class': 'OTHER'}, 'collaborators': [{'name': 'International Islamic University, Islamabad', 'class': 'OTHER'}, {'name': 'Universitas Ahmad Dahlan', 'class': 'OTHER'}, {'name': 'Gadjah Mada University', 'class': 'OTHER'}, {'name': 'Ibn Sina University of Medical and Pharmaceutical Sciences, Iraq', 'class': 'OTHER'}, {'name': 'Al-Mustansiriyah University', 'class': 'OTHER'}, {'name': 'Hasan Kalyoncu University', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'University of Malaya', 'class': 'OTHER'}, {'name': 'University of Social Welfare and Rehabilitation Science', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Research Fellow', 'investigatorFullName': 'Sandila Tanveer', 'investigatorAffiliation': 'University of Otago'}}}}