Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-30 @ 12:10 PM
Study NCT ID:
NCT04832035
Status:
UNKNOWN
Last Update Posted:
2021-04-09
First Post:
2021-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integration of Refugees Into Public Mental Health Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-06', 'studyFirstSubmitDate': '2021-04-01', 'studyFirstSubmitQcDate': '2021-04-01', 'lastUpdatePostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Service utilisation', 'timeFrame': '6 months after study inclusion', 'description': 'Percentage of participants who utilise psychotherapeutic services'}, {'measure': 'Psychiatric symptom change', 'timeFrame': 'assessments 6 and 12 months after study inclusion', 'description': 'Self-report of psychiatric symptoms by means of questionnaires'}], 'secondaryOutcomes': [{'measure': 'Percentage correctly identified refugees with mental health problems', 'timeFrame': 'two weeks', 'description': 'Comparison of peer screening and expert diagnostic assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychiatric Disorders From Chapters 3 and 4 of ICD10']}, 'descriptionModule': {'briefSummary': 'There are specific barriers to utilise psychotherapeutic services for refugees with mental health problems in the German public health care system. This study aims to evaluate additional organisational components that are hypothesised to improve service utilisation.\n\nIn a randomised controlled trial, refugees with mental health problems are identified by peers, subsequently assessed by professional staff and referred to public psychotherapeutic health services who offer standard care. Participants are assigned to care as usual or to "coordinated and peer supported mental health care"; the latter includes several additional organisational assistance components, i.e. a coordination center, trained peers to support treatment utilisation, a support and training center for therapists, and a interpreter pool. Measures include service utilisation and symptom change after 6 months. Furthermore the study evaluates whether trained peers can correctly identify participants with mental health problems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Psychiatric diagnosis from Chapters 3 and 4 of ICD10\n* Participant applied for asylum in Germany\n* Entry to Germany after 2012\n* Participants is motivated to utilise psychotherapeutic services\n* Patient speaks one of the languages in which services are offered (i.e. German, English, French, Arabic, Kurdish, Dari, Farsi, Urdu, Pashto, Tirginya, Somali)\n\nExclusion Criteria:\n\n* Mental disorder that requires inpatient treatment'}, 'identificationModule': {'nctId': 'NCT04832035', 'acronym': 'INT_REF_MH', 'briefTitle': 'Integration of Refugees Into Public Mental Health Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Konstanz'}, 'officialTitle': 'Integration of Refugees With Mental Disorders Into the Public Psychotherapeutic Health Care Services - a Model Project With Trained Peers', 'orgStudyIdInfo': {'id': 'Refugee Integration 2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard psychotherapeutic care + coordinated and peer supported mental health care"', 'description': 'Participants receive standard psychotherapeutic care in the public healthcare system. For participants and therapists in this group standard care and additional organisational support is available which is labeled "coordinated and peer supported mental health care". This includes several additional organisational assistance components that are currently not part of the services of the public mental health care system, i.e. a coordination center, trained peers to support treatment utilisation, a support and training center for therapists, and an interpreter pool.This is Treatment as Usual plus coordination and peer support.', 'interventionNames': ['Other: "coordinated and peer supported mental health care"', 'Behavioral: "standard psychotherapeutic care in the public healthcare system"']}, {'type': 'OTHER', 'label': 'Standard psychotherapeutic care"', 'description': 'Participants receive standard psychotherapeutic care in the public healthcare system. For participants in this group no additional organisational support is available. This is Treatment as Usual.', 'interventionNames': ['Behavioral: "standard psychotherapeutic care in the public healthcare system"']}], 'interventions': [{'name': '"coordinated and peer supported mental health care"', 'type': 'OTHER', 'description': 'Health services, coordination of services, method to support utilization', 'armGroupLabels': ['Standard psychotherapeutic care + coordinated and peer supported mental health care"']}, {'name': '"standard psychotherapeutic care in the public healthcare system"', 'type': 'BEHAVIORAL', 'description': 'Psychotherapeutic services that are financed by the public health insurance system.', 'armGroupLabels': ['Standard psychotherapeutic care + coordinated and peer supported mental health care"', 'Standard psychotherapeutic care"']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78464', 'city': 'Konstanz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Odenwald, PhD', 'role': 'CONTACT', 'email': 'michael.odenwald@uni-konstanz.de', 'phone': '+49 7531 884621'}, {'name': 'Anne Schawohl, MA', 'role': 'CONTACT', 'email': 'anne.schawohl@uni-konstanz.de', 'phone': '+49 7531 883589'}], 'facility': 'University of Konstanz, Psychotherapy Outpatient Clinic', 'geoPoint': {'lat': 47.66033, 'lon': 9.17582}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Konstanz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vivo international e.V.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CEO psychotherapeutic outpatient clinic, leading psychologist research ward', 'investigatorFullName': 'Michael Odenwald', 'investigatorAffiliation': 'University of Konstanz'}}}}