Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-04-17 @ 5:47 PM
Study NCT ID:
NCT01964092
Status:
COMPLETED
Last Update Posted:
2020-05-14
First Post:
2013-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect Evaluation of Individual Placement and Support (IPS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 's.e.reme@psykologi.uio.no', 'phone': '22845236', 'title': 'Silje Endresen Reme', 'phoneExt': '+47', 'organization': 'University of Oslo'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During the follow-up period, 0-18 months.', 'description': 'The follow-up which was offered to participants has not been led to adverse events in the current nor previous studies, as it does not pose specific threats or risks to participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Individual Placement and Support', 'description': 'Individual Placement and Support (IPS) is a well-defined intervention aiming to help people with disabilities participate in the competitive labor market by working in jobs they prefer with the professional help that they need. IPS actively facilitates job acquisition and provides ongoing support once the client is employed.\n\nIndividual Placement and Support', 'otherNumAtRisk': 227, 'deathsNumAtRisk': 227, 'otherNumAffected': 0, 'seriousNumAtRisk': 227, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ordinary Employment Schemes', 'description': 'The control group will receive treatment as usual in terms of the ordinary employment schemes offered to this group, primarily Work with assistance and/or Traineeship in a sheltered business.\n\nOrdinary employment schemes', 'otherNumAtRisk': 181, 'deathsNumAtRisk': 181, 'otherNumAffected': 0, 'seriousNumAtRisk': 181, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Labor Market Participation in Ordinary Paid Employment, or Education.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Individual Placement and Support', 'description': 'Individual Placement and Support (IPS) is a well-defined intervention aiming to help people with disabilities participate in the competitive labor market by working in jobs they prefer with the professional help that they need. IPS actively facilitates job acquisition and provides ongoing support once the client is employed.\n\nIndividual Placement and Support'}, {'id': 'OG001', 'title': 'Ordinary Employment Schemes', 'description': 'The control group will receive treatment as usual in terms of the ordinary employment schemes offered to this group, primarily Work with assistance and/or Traineeship in a sheltered business.\n\nOrdinary employment schemes'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year (2016)', 'description': 'Labor market participation is operationalized as being registered in the Norwegian Labour and Welfare Administrations (NAV) State Register of Employers and Employees, and not as a recipient of unemployment or sickness benefits, not receiving work assessment allowance or disability pension with a higher degree of disability than by study inclusion, and registered yearly income.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Individual Placement and Support', 'description': 'Individual Placement and Support (IPS) is a well-defined intervention aiming to help people with disabilities participate in the competitive labor market by working in jobs they prefer with the professional help that they need. IPS actively facilitates job acquisition and provides ongoing support once the client is employed.\n\nIndividual Placement and Support'}, {'id': 'FG001', 'title': 'Ordinary Employment Schemes', 'description': 'The control group will receive treatment as usual in terms of the ordinary employment schemes offered to this group, primarily Work with assistance and/or Traineeship in a sheltered business.\n\nOrdinary employment schemes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '229'}, {'groupId': 'FG001', 'numSubjects': '181'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '227'}, {'groupId': 'FG001', 'numSubjects': '181'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '410', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Individual Placement and Support', 'description': 'Individual Placement and Support (IPS) is a well-defined intervention aiming to help people with disabilities participate in the competitive labor market by working in jobs they prefer with the professional help that they need. IPS actively facilitates job acquisition and provides ongoing support once the client is employed.\n\nIndividual Placement and Support'}, {'id': 'BG001', 'title': 'Ordinary Employment Schemes', 'description': 'The control group will receive treatment as usual in terms of the ordinary employment schemes offered to this group, primarily Work with assistance and/or Traineeship in a sheltered business.\n\nOrdinary employment schemes'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '410', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.86', 'spread': '10.81', 'groupId': 'BG000'}, {'value': '34.77', 'spread': '10.76', 'groupId': 'BG001'}, {'value': '34.82', 'spread': '10.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Norway', 'categories': [{'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '410', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 410}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-04', 'studyFirstSubmitDate': '2013-07-17', 'resultsFirstSubmitDate': '2019-09-28', 'studyFirstSubmitQcDate': '2013-10-16', 'lastUpdatePostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-04', 'studyFirstPostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Labor Market Participation in Ordinary Paid Employment, or Education.', 'timeFrame': '1 year (2016)', 'description': 'Labor market participation is operationalized as being registered in the Norwegian Labour and Welfare Administrations (NAV) State Register of Employers and Employees, and not as a recipient of unemployment or sickness benefits, not receiving work assessment allowance or disability pension with a higher degree of disability than by study inclusion, and registered yearly income.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Disability', 'Individual placement and support', 'Mental health', 'Quality of life', 'Randomized controlled trial', 'Rehabilitation', 'Return to work', 'Supported employment'], 'conditions': ['Psychosis', 'Substance Abuse', 'Depression', 'Anxiety']}, 'referencesModule': {'references': [{'pmid': '25403470', 'type': 'BACKGROUND', 'citation': 'Sveinsdottir V, Lovvik C, Fyhn T, Monstad K, Ludvigsen K, Overland S, Reme SE. Protocol for the effect evaluation of Individual Placement and Support (IPS): a randomized controlled multicenter trial of IPS versus treatment as usual for patients with moderate to severe mental illness in Norway. BMC Psychiatry. 2014 Nov 18;14:307. doi: 10.1186/s12888-014-0307-7.'}, {'pmid': '33145494', 'type': 'DERIVED', 'citation': 'Fyhn T, Ludvigsen K, Reme SE, Schaafsma F. A structured mixed method process evaluation of a randomized controlled trial of Individual Placement and Support (IPS). Implement Sci Commun. 2020 Oct 30;1:95. doi: 10.1186/s43058-020-00083-9. eCollection 2020.'}, {'pmid': '30074050', 'type': 'DERIVED', 'citation': 'Reme SE, Monstad K, Fyhn T, Sveinsdottir V, Lovvik C, Lie SA, Overland S. A randomized controlled multicenter trial of individual placement and support for patients with moderate-to-severe mental illness. Scand J Work Environ Health. 2019 Jan 1;45(1):33-41. doi: 10.5271/sjweh.3753. Epub 2018 Aug 2.'}], 'seeAlsoLinks': [{'url': 'http://uni.no/nb/uni-helse/stress-helse-og-rehabilitering/effektevaluering-av-individuell-jobbsttte-ips-2/', 'label': 'Study website'}]}, 'descriptionModule': {'briefSummary': 'Roughly one third of disability pensions issued in Norway are classified as mental and behavioral disorders. The proposed study aims to evaluate the effect of an innovative intervention for returning people with moderate to severe mental health disorders to work: Individual Placement and Support (IPS).', 'detailedDescription': 'The current employment schemes offered to this diagnostic group are primarily based on a train-and-place principle with assisted or sheltered employment. Building on a place-and-train principle, rather, the IPS model of supported employment in real-life competitive work settings has proven largely successful in previous studies, but has never been tested in this group in the Norwegian context.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '67 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be undergoing treatment for moderate to severe mental health problems.\n* Participants must have an expressed desire to work.\n* Participants must have sufficient Norwegian reading and writing skills.\n\nExclusion Criteria:\n\n* Participants are not undergoing treatment for moderate to severe mental health problems.\n* Participants do not have an expressed desire to work.\n* Participants do not have sufficient Norwegian reading and writing skills.'}, 'identificationModule': {'nctId': 'NCT01964092', 'briefTitle': 'Effect Evaluation of Individual Placement and Support (IPS)', 'organization': {'class': 'OTHER', 'fullName': 'NORCE Norwegian Research Centre AS'}, 'officialTitle': 'Effect Evaluation of Individual Placement and Support (IPS)', 'orgStudyIdInfo': {'id': 'IPS-NAV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individual Placement and Support', 'description': 'Individual Placement and Support (IPS) is a well-defined intervention aiming to help people with disabilities participate in the competitive labor market by working in jobs they prefer with the professional help that they need. IPS actively facilitates job acquisition and provides ongoing support once the client is employed.', 'interventionNames': ['Behavioral: Individual Placement and Support']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ordinary employment schemes', 'description': 'The control group will receive treatment as usual in terms of the ordinary employment schemes offered to this group, primarily Work with assistance and/or Traineeship in a sheltered business.', 'interventionNames': ['Behavioral: Ordinary employment schemes']}], 'interventions': [{'name': 'Individual Placement and Support', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Individual Placement and Support']}, {'name': 'Ordinary employment schemes', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Ordinary employment schemes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5014', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Uni Research', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Silje E Reme, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NORCE Norwegian Research Centre AS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NORCE Norwegian Research Centre AS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian Labour and Welfare Administration', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}