Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT03720769
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2018-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing e-Mental Health in Lebanon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1248}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-28', 'studyFirstSubmitDate': '2018-10-24', 'studyFirstSubmitQcDate': '2018-10-24', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Client Satisfaction Questionnaire (CSQ-3)', 'timeFrame': 'only at post-assessment (8 weeks after baseline)'}], 'primaryOutcomes': [{'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': '8 weeks', 'description': 'Self-administered instrument for depression screening (intention-to-treat analysis)'}, {'measure': 'WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)', 'timeFrame': '8 weeks', 'description': 'Generic assessment instrument for health and disability (intention-to-treat analysis)'}], 'secondaryOutcomes': [{'measure': 'WHO-5 Well-Being Index', 'timeFrame': '8 weeks'}, {'measure': 'Generalized Anxiety Disorder - 7 Questionnaire (GAD-7)', 'timeFrame': '8 weeks'}, {'measure': 'PTSD Checklist for DSM-5 (PCL-6)', 'timeFrame': '8 weeks'}, {'measure': 'Self-defined psychosocial problems (PSYCHLOPS)', 'timeFrame': '8 weeks'}, {'measure': '(Adapted) Client Service Receipt Inventory (CSRI)', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '41306862', 'type': 'DERIVED', 'citation': "Abi Ramia J, Khoury S, Armani N, Cuijpers P, Carswell K, van 't Hof E, Zoghbi E, Sijbrandij M, El Chammay R. From research to real-life implementation: an evaluation of the scale up of a guided digital mental health intervention in Lebanon: Step-by-Step. Front Public Health. 2025 Nov 11;13:1665093. doi: 10.3389/fpubh.2025.1665093. eCollection 2025."}, {'pmid': '38810255', 'type': 'DERIVED', 'citation': "Abi Hana R, Abi Ramia J, Burchert S, Carswell K, Cuijpers P, Heim E, Knaevelsrud C, Noun P, Sijbrandij M, van Ommeren M, Van't Hof E, Wijnen B, Zoghbi E, El Chammay R, Smit F. Cost-Effectiveness of Digital Mental Health Versus Usual Care During Humanitarian Crises in Lebanon: Pragmatic Randomized Trial. JMIR Ment Health. 2024 May 29;11:e55544. doi: 10.2196/55544."}, {'pmid': '35737665', 'type': 'DERIVED', 'citation': "Cuijpers P, Heim E, Abi Ramia J, Burchert S, Carswell K, Cornelisz I, Knaevelsrud C, Noun P, van Klaveren C, Van't Hof E, Zoghbi E, van Ommeren M, El Chammay R. Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial. PLoS Med. 2022 Jun 23;19(6):e1004025. doi: 10.1371/journal.pmed.1004025. eCollection 2022 Jun."}, {'pmid': '35577536', 'type': 'DERIVED', 'citation': "Cuijpers P, Heim E, Ramia JA, Burchert S, Carswell K, Cornelisz I, Knaevelsrud C, Noun P, van Klaveren C, Van't Hof E, Zoghbi E, van Ommeren M, El Chammay R. Guided digital health intervention for depression in Lebanon: randomised trial. Evid Based Ment Health. 2022 Dec;25(e1):e34-e40. doi: 10.1136/ebmental-2021-300416. Epub 2022 May 16."}, {'pmid': '33507158', 'type': 'DERIVED', 'citation': "van 't Hof E, Heim E, Abi Ramia J, Burchert S, Cornelisz I, Cuijpers P, El Chammay R, Harper Shehadeh M, Noun P, Smit F, van Klaveren C, van Ommeren M, Zoghbi E, Carswell K. Evaluating the Effectiveness of an E-Mental Health Intervention for People Living in Lebanon: Protocol for Two Randomized Controlled Trials. JMIR Res Protoc. 2021 Jan 28;10(1):e21585. doi: 10.2196/21585."}]}, 'descriptionModule': {'briefSummary': 'The study objective is to test a guided e-mental health intervention called Step-by-Step for people living in Lebanon. Step-by-Step is a self-help programme delivered through an app or website and aims to treat symptoms of depression and other symptoms of psychological distress. First, a small study will be conducted to test the research procedure. Second, a large study will be conducted to test the effectiveness of Step-by-Step.\n\nPeople residing in Lebanon (i.e. Lebanese, Palestinians and Syrian displaced people), above the age of 18 with symptoms of depression will be recruited through social media, posters, radio and television adverts, etc. Minors (under the age of 18) and people who have plans to end their life will be excluded from the study.\n\nTo test whether the use of Step-by-Step improves symptoms of depression, two groups will be compared. Participants in the intervention group will receive Step-by-Step, while those in the control group will receive basic information about depression and a list of health centres where they can get face-to-face help that is based on evidence. In addition, participants in the intervention group will receive weekly phone or chat support (up to 15 minutes) provided through lay helpers who were trained and work under the supervision of a trained clinical psychologist. The study hypothesises that participants who receive Step-by-Step will have a higher symptom improvement than participants who receive basic information.\n\nIn order to assess symptoms of depression and other symptoms of psychological distress, participants in this study will complete several questionnaires three times: At the beginning of the study, after 8 weeks, and then three months later (i.e. 5 months after the beginning of the study).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 or above\n* PHQ-9 sum score above 9\n* WHODAS 2.0 sum score above 16\n\nExclusion Criteria:\n\n* Serious thoughts or plans to end one's life"}, 'identificationModule': {'nctId': 'NCT03720769', 'briefTitle': 'Testing e-Mental Health in Lebanon', 'organization': {'class': 'OTHER', 'fullName': 'VU University of Amsterdam'}, 'officialTitle': 'Increasing Access to Mental Health Care for People Living in Lebanon: An E-Mental Health Intervention', 'orgStudyIdInfo': {'id': 'ERC.0002797'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Step-by-Step', 'interventionNames': ['Behavioral: Step-by-Step']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced care as usual', 'interventionNames': ['Behavioral: Enhanced care as usual']}], 'interventions': [{'name': 'Step-by-Step', 'type': 'BEHAVIORAL', 'description': 'Guided self-help programme delivered through an app/website for the treatment of depression', 'armGroupLabels': ['Step-by-Step']}, {'name': 'Enhanced care as usual', 'type': 'BEHAVIORAL', 'description': 'Psychoeducation and information about where to get help (i.e., mhGAP trained primary health care centres)', 'armGroupLabels': ['Enhanced care as usual']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Ministry of Public Health', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Pim Cuijpers, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VU Amsterdam'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VU University of Amsterdam', 'class': 'OTHER'}, 'collaborators': [{'name': 'World Health Organization', 'class': 'OTHER'}, {'name': 'Ministry of Public Health, Lebanon', 'class': 'UNKNOWN'}, {'name': 'Freie Universität Berlin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pim Cuijpers', 'investigatorAffiliation': 'VU University of Amsterdam'}}}}