Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-03-01 @ 9:43 PM
Study NCT ID:
NCT04083404
Status:
COMPLETED
Last Update Posted:
2020-01-09
First Post:
2019-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigating Psychosocial Predictors & Employment Outcomes of Enhanced IPS Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sprior@qmu.ac.uk', 'phone': '44 (0)131 474 0000', 'title': 'Dr Susan Prior', 'organization': 'Queen Margaret University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1day to 69mths', 'eventGroups': [{'id': 'EG000', 'title': 'Enhanced IPS Programme', 'description': 'An enhanced individual placement and support (IPS) intervention based on the Model of Human Occupation', 'otherNumAtRisk': 202, 'deathsNumAtRisk': 202, 'otherNumAffected': 0, 'seriousNumAtRisk': 202, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Attainment of Employment or Education', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced IPS Programme', 'description': 'An enhanced individual placement and support (IPS) intervention based on the Model of Human Occupation'}], 'classes': [{'categories': [{'title': 'Attained employment or education', 'measurements': [{'value': '128', 'groupId': 'OG000'}]}, {'title': 'Did not attain employment or education', 'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1day', 'description': 'successful attainment of open employment or educational opportunity / unsuccessful', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time to Attainment of Employment or Education', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced IPS Programme', 'description': 'An enhanced individual placement and support (IPS) intervention based on the Model of Human Occupation'}], 'classes': [{'categories': [{'measurements': [{'value': '8.435', 'groupId': 'OG000', 'lowerLimit': '5.055', 'upperLimit': '16.742'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1day-69months', 'description': 'Time to outcome for those successfully attaining employment or education', 'unitOfMeasure': 'months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enhanced Individual Placement and Support (IPS) Programme', 'description': 'An enhanced individual placement and support (IPS) intervention based on the Model of Human Occupation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '202'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '202'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Enhanced IPS Programme', 'description': 'An enhanced individual placement and support (IPS) intervention based on the Model of Human Occupation'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.4', 'spread': '10.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '124', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'White', 'measurements': [{'value': '185', 'groupId': 'BG000'}]}, {'title': 'Other ethnic group', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital Status', 'classes': [{'categories': [{'title': 'Married / de facto relationship', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Single', 'measurements': [{'value': '163', 'groupId': 'BG000'}]}, {'title': 'missing data', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Social Situation', 'classes': [{'categories': [{'title': 'living with others', 'measurements': [{'value': '97', 'groupId': 'BG000'}]}, {'title': 'living alone', 'measurements': [{'value': '101', 'groupId': 'BG000'}]}, {'title': 'missing data', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Scottish Indices of Multiple Deprivation', 'classes': [{'categories': [{'title': 'most deprived quintile 1', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'quintile 2', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'quintile 3', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'quintile 4', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'least deprived quintile 5', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The Scottish Index of Multiple Deprivation is the Scottish Government's official tool for identifying areas in Scotland concentrations of deprivation by incorporating several different aspects of deprivation (multiple-deprivations) and combining them into a single index.\n\nCounts of participants living in each quintile are provided, from the most deprived 20% to the least deprived 20%.", 'unitOfMeasure': 'Participants'}, {'title': 'Educational Attainment', 'classes': [{'categories': [{'title': 'Did Not Attain School Quals', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Exams from School', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': 'Further Education', 'measurements': [{'value': '121', 'groupId': 'BG000'}]}, {'title': 'missing data', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Employment', 'classes': [{'categories': [{'title': 'Previous employment', 'measurements': [{'value': '182', 'groupId': 'BG000'}]}, {'title': 'No previous employment', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ICD10', 'classes': [{'categories': [{'title': 'ICD10 F2', 'measurements': [{'value': '105', 'groupId': 'BG000'}]}, {'title': 'ICD10 F3', 'measurements': [{'value': '67', 'groupId': 'BG000'}]}, {'title': 'ICD10 other', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The International Classification of Diseases defines the universe of diseases, disorders, injuries and other related health conditions. Complex mental health conditions experienced by participants of this study were classified under the categories ICD F2; Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders. And ICD F3; Mood \\[affective\\] disorders. Or ICD other.', 'unitOfMeasure': 'Participants'}, {'title': 'Worker Role Interview Item Assesses Abilities and Limitations', 'classes': [{'categories': [{'title': 'Strongly supports', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Supports', 'measurements': [{'value': '102', 'groupId': 'BG000'}]}, {'title': 'Interferes', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}, {'title': 'Strongly interferes', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The worker role interview (WRI) (Braveman et al. 2005) is a semi-structured interview \\& rating scale identifying psychosocial factors that influence a client's ability to work. The WRI is a valid, reliable assessment tool, which can discriminate between levels of work status.\n\nAssesses Abilities and Limitations is defined as the individual's capacity to accurately assess his/her abilities and what they mean for work performance (Braveman et al 2005).\n\nClinicians determine if the item strongly supports; supports; interferes or strongly interferes with an individual's ability to work.", 'unitOfMeasure': 'Participants'}, {'title': 'Worker Role Interview Item Expectation of job success', 'classes': [{'categories': [{'title': 'Strongly supports', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Supports', 'measurements': [{'value': '92', 'groupId': 'BG000'}]}, {'title': 'Interferes', 'measurements': [{'value': '88', 'groupId': 'BG000'}]}, {'title': 'Strongly interferes', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The worker role interview (WRI) (Braveman et al. 2005) is a semi-structured interview \\& rating scale identifying psychosocial factors that influence a client's ability to work. The WRI is a valid, reliable assessment tool, which can discriminate between levels of work status.\n\nExpectation of Success in Work: a client's belief that he/she will be able to work. Overall, raters are guided to consider the general degree of optimism the person has about working.\n\nClinicians determine if the item strongly supports; supports; interferes or strongly interferes with an individual's ability to work.", 'unitOfMeasure': 'Participants'}, {'title': 'Worker Role Interview Item Takes Responsibility', 'classes': [{'categories': [{'title': 'Strongly supports', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Supports', 'measurements': [{'value': '81', 'groupId': 'BG000'}]}, {'title': 'Interferes', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}, {'title': 'Strongly interferes', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The worker role interview (WRI) (Braveman et al. 2005) is a semi-structured interview \\& rating scale identifying psychosocial factors that influence a client's ability to work. The WRI is a valid, reliable assessment tool, which can discriminate between levels of work status.\n\nTakes Responsibility: how much responsibility a client takes for his/her work actions and their consequences.\n\nClinicians determine if the item strongly supports; supports; interferes or strongly interferes with an individual's ability to work.", 'unitOfMeasure': 'Participants'}, {'title': 'Worker Role Interview Item Commitment to work', 'classes': [{'categories': [{'title': 'Strongly supports', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}, {'title': 'Supports', 'measurements': [{'value': '106', 'groupId': 'BG000'}]}, {'title': 'Interferes', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Strongly interferes', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The worker role interview (WRI) (Braveman et al. 2005) is a semi-structured interview \\& rating scale identifying psychosocial factors that influence a client's ability to work. The WRI is a valid, reliable assessment tool, which can discriminate between levels of work status.\n\nCommitment to Work: Defined as a client's commitment to work and importance placed on work.\n\nClinicians determine if the item strongly supports; supports; interferes or strongly interferes with an individual's ability to work.", 'unitOfMeasure': 'Participants'}, {'title': 'Worker Role Interview Item Work-related goals', 'classes': [{'categories': [{'title': 'Strongly supports', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Supports', 'measurements': [{'value': '89', 'groupId': 'BG000'}]}, {'title': 'Interferes', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}, {'title': 'Strongly interferes', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The worker role interview (WRI) (Braveman et al. 2005) is a semi-structured interview \\& rating scale identifying psychosocial factors that influence a client's ability to work. The WRI is a valid, reliable assessment tool, which can discriminate between levels of work status.\n\nWork-Related Goals: Defined as the client's ability to set and attain goals at his/her work setting.\n\nClinicians determine if the item strongly supports; supports; interferes or strongly interferes with an individual's ability to work.", 'unitOfMeasure': 'Participants'}, {'title': 'Worker Role Interview Item Enjoys work', 'classes': [{'categories': [{'title': 'Strongly supports', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Supports', 'measurements': [{'value': '114', 'groupId': 'BG000'}]}, {'title': 'Interferes', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Strongly interferes', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The worker role interview (WRI) (Braveman et al. 2005) is a semi-structured interview \\& rating scale identifying psychosocial factors that influence a client's ability to work. The WRI is a valid, reliable assessment tool, which can discriminate between levels of work status.\n\nEnjoys Work: Defined as the pleasure or enjoyment client finds within work. Clinicians determine if the item strongly supports; supports; interferes or strongly interferes with an individual's ability to work.", 'unitOfMeasure': 'Participants'}, {'title': 'Worker Role Interview Item Pursues interests', 'classes': [{'categories': [{'title': 'Strongly supports', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Supports', 'measurements': [{'value': '77', 'groupId': 'BG000'}]}, {'title': 'Interferes', 'measurements': [{'value': '81', 'groupId': 'BG000'}]}, {'title': 'Strongly interferes', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The worker role interview (WRI) (Braveman et al. 2005) is a semi-structured interview \\& rating scale identifying psychosocial factors that influence a client's ability to work. The WRI is a valid, reliable assessment tool, which can discriminate between levels of work status.\n\nPursues Interests: the ability of an individual to assess his/her own interests and find ways to use these skills in and/or outside of the work situation.\n\nClinicians determine if the item strongly supports; supports; interferes or strongly interferes with an individual's ability to work.", 'unitOfMeasure': 'Participants'}, {'title': 'Worker Role Interview Item Appraises work expectations', 'classes': [{'categories': [{'title': 'Strongly supports', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Supports', 'measurements': [{'value': '108', 'groupId': 'BG000'}]}, {'title': 'Interferes', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Strongly interferes', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The worker role interview (WRI) (Braveman et al. 2005) is a semi-structured interview \\& rating scale identifying psychosocial factors that influence a client's ability to work. The WRI is a valid, reliable assessment tool, which can discriminate between levels of work status.\n\nAppraises Work Expectations: ability to internalize both general and specific expectations of work.\n\nClinicians determine if the item strongly supports; supports; interferes or strongly interferes with an individual's ability to work.", 'unitOfMeasure': 'Participants'}, {'title': 'Worker Role Interview Item Influence of other roles', 'classes': [{'categories': [{'title': 'Strongly supports', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Supports', 'measurements': [{'value': '96', 'groupId': 'BG000'}]}, {'title': 'Interferes', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': 'Strongly interferes', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The worker role interview (WRI) (Braveman et al. 2005) is a semi-structured interview \\& rating scale identifying psychosocial factors that influence a client's ability to work. The WRI is a valid, reliable assessment tool, which can discriminate between levels of work status.\n\nInfluence of Other Roles: Defined as how much other roles in the client's life influence his/her return to work.\n\nClinicians determine if the item strongly supports; supports; interferes or strongly interferes with an individual's ability to work.", 'unitOfMeasure': 'Participants'}, {'title': 'Worker Role Interview Item Work Habits', 'classes': [{'categories': [{'title': 'Strongly supports', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Supports', 'measurements': [{'value': '96', 'groupId': 'BG000'}]}, {'title': 'Interferes', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Strongly interferes', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The worker role interview (WRI) (Braveman et al. 2005) is a semi-structured interview \\& rating scale identifying psychosocial factors that influence a client's ability to work. The WRI is a valid, reliable assessment tool, which can discriminate between levels of work status.\n\nWork Habits: Defined as the degree of organization and routine in work. Clinicians determine if the item strongly supports; supports; interferes or strongly interferes with an individual's ability to work.", 'unitOfMeasure': 'Participants'}, {'title': 'Worker Role Interview Item Daily Routine', 'classes': [{'categories': [{'title': 'Strongly supports', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Supports', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': 'Interferes', 'measurements': [{'value': '106', 'groupId': 'BG000'}]}, {'title': 'Strongly interferes', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The worker role interview (WRI) (Braveman et al. 2005) is a semi-structured interview \\& rating scale identifying psychosocial factors that influence a client's ability to work. The WRI is a valid, reliable assessment tool, which can discriminate between levels of work status.\n\nDaily Routine: Defined as the degree of organization and routine outside of work.\n\nClinicians determine if the item strongly supports; supports; interferes or strongly interferes with an individual's ability to work.", 'unitOfMeasure': 'Participants'}, {'title': 'Worker Role Interview Item Adapts routines to minimize difficulties', 'classes': [{'categories': [{'title': 'Strongly supports', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Supports', 'measurements': [{'value': '87', 'groupId': 'BG000'}]}, {'title': 'Interferes', 'measurements': [{'value': '85', 'groupId': 'BG000'}]}, {'title': 'Strongly interferes', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The worker role interview (WRI) (Braveman et al. 2005) is a semi-structured interview \\& rating scale identifying psychosocial factors that influence a client's ability to work. The WRI is a valid, reliable assessment tool, which can discriminate between levels of work status.\n\nAdapts Routines to Minimize Difficulties: Defined as how the person has managed use of time, routine, and habits since the injury or since being out of work.\n\nClinicians determine if the item strongly supports; supports; interferes or strongly interferes with an individual's ability to work.", 'unitOfMeasure': 'Participants'}, {'title': 'Worker Role Interview Item Perception of physical work setting', 'classes': [{'categories': [{'title': 'Strongly supports', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Supports', 'measurements': [{'value': '107', 'groupId': 'BG000'}]}, {'title': 'Interferes', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Strongly interferes', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The worker role interview (WRI) (Braveman et al. 2005) is a semi-structured interview \\& rating scale identifying psychosocial factors that influence a client's ability to work. The WRI is a valid, reliable assessment tool, which can discriminate between levels of work status.\n\nPerception of Physical Work Setting: The client's impression of how a work environment may support or hinder his/ her return to work or finding and keeping work Clinicians determine if the item strongly supports; supports; interferes or strongly interferes with an individual's ability to work.", 'unitOfMeasure': 'Participants'}, {'title': 'Worker Role Interview Item Perception of family and peers', 'classes': [{'categories': [{'title': 'Strongly supports', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Supports', 'measurements': [{'value': '92', 'groupId': 'BG000'}]}, {'title': 'Interferes', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Strongly interferes', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The worker role interview (WRI) (Braveman et al. 2005) is a semi-structured interview \\& rating scale identifying psychosocial factors that influence a client's ability to work. The WRI is a valid, reliable assessment tool, which can discriminate between levels of work status.\n\nPerception of Family and Peers: Defined as the influence family's and peers' have on the client's ability to return to previous work Clinicians determine if the item strongly supports; supports; interferes or strongly interferes with an individual's ability to work.", 'unitOfMeasure': 'Participants'}, {'title': 'Worker Role Interview Item Perception of boss and/or company', 'classes': [{'categories': [{'title': 'Strongly supports', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Supports', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Interferes', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}, {'title': 'Strongly interferes', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The worker role interview (WRI) (Braveman et al. 2005) is a semi-structured interview \\& rating scale identifying psychosocial factors that influence a client's ability to work. The WRI is a valid, reliable assessment tool, which can discriminate between levels of work status.\n\nPerception of Boss and/or Company: Defined as the influence of boss and/or company on the ability of client to return to previous work or find and keep work.\n\nClinicians determine if the item strongly supports; supports; interferes or strongly interferes with an individual's ability to work.", 'unitOfMeasure': 'Participants'}, {'title': 'Worker Role Interview Item Perception of co-workers', 'classes': [{'categories': [{'title': 'Strongly supports', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Supports', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}, {'title': 'Interferes', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}, {'title': 'Strongly interferes', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The worker role interview (WRI) (Braveman et al. 2005) is a semi-structured interview \\& rating scale identifying psychosocial factors that influence a client's ability to work. The WRI is a valid, reliable assessment tool, which can discriminate between levels of work status.\n\nPerception of Co-workers: Defined as co-workers' influence on client's ability to return to previous work and find and keep work.\n\nClinicians determine if the item strongly supports; supports; interferes or strongly interferes with an individual's ability to work.", 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-01-01', 'size': 115700, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-18T07:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-18', 'studyFirstSubmitDate': '2019-09-05', 'resultsFirstSubmitDate': '2019-09-19', 'studyFirstSubmitQcDate': '2019-09-05', 'lastUpdatePostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-18', 'studyFirstPostDateStruct': {'date': '2019-09-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to Attainment of Employment or Education', 'timeFrame': '1day-69months', 'description': 'Time to outcome for those successfully attaining employment or education'}], 'primaryOutcomes': [{'measure': 'Attainment of Employment or Education', 'timeFrame': '1day', 'description': 'successful attainment of open employment or educational opportunity / unsuccessful'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Complex mental health', 'employment', 'Enhanced Individual Placement & Support', 'Model of Human Occupation', 'Worker Role Interview'], 'conditions': ['Psychiatric Disorder']}, 'referencesModule': {'references': [{'pmid': '24030739', 'type': 'BACKGROUND', 'citation': 'Kinoshita Y, Furukawa TA, Kinoshita K, Honyashiki M, Omori IM, Marshall M, Bond GR, Huxley P, Amano N, Kingdon D. Supported employment for adults with severe mental illness. Cochrane Database Syst Rev. 2013 Sep 13;2013(9):CD008297. doi: 10.1002/14651858.CD008297.pub2.'}, {'pmid': '22660842', 'type': 'BACKGROUND', 'citation': 'Bond GR, Peterson AE, Becker DR, Drake RE. Validation of the Revised Individual Placement and Support Fidelity Scale (IPS-25). Psychiatr Serv. 2012 Aug;63(8):758-63. doi: 10.1176/appi.ps.201100476.'}, {'pmid': '17006008', 'type': 'BACKGROUND', 'citation': 'Forsyth K, Braveman B, Kielhofner G, Ekbladh E, Haglund L, Fenger K, Keller J. Psychometric properties of the Worker Role Interview. Work. 2006;27(3):313-8.'}, {'pmid': '32641009', 'type': 'DERIVED', 'citation': 'Prior S, Maciver D, Aas RW, Kirsh B, Lexen A, van Niekerk L, Irvine Fitzpatrick L, Forsyth K. An enhanced individual placement and support (IPS) intervention based on the Model of Human Occupation (MOHO); a prospective cohort study. BMC Psychiatry. 2020 Jul 8;20(1):361. doi: 10.1186/s12888-020-02745-3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this cohort study, using an existing database, is to seek to describe the relationship between psychosocial factors (independent variables) and employment outcomes (dependent variables) in a population of people with complex mental health problems receiving evidence-based supported employment (EBSE) augmented with theory-driven occupational therapy interventions. The intention is to understand the predictive nature of psychosocial factors on the positive outcome of success in achieving paid employment.\n\nThe Worker role interview (WRI) is routinely used in the research site; an National health Service (NHS) occupational therapy led vocational rehabilitation delivering EBSE service for people with complex mental health problems. An existing database of initial assessments and employment outcomes is available for investigation.', 'detailedDescription': "The cohort study will be undertaken utilising a secondary dataset from an established vocational rehabilitation service (VRS). This service is experienced in providing intervention based on individual placement and support (IPS) with established high fidelity to the model. The team's interventions are also guided by the model of human occupation, (MOHO) and the Worker Role Interview is routinely completed with all patients accessing the service. The Worker Role Interview is a valid reliable measure of psychosocial items measuring of readiness for employment.\n\nThe consistency of intervention will be ensured as the service is routinely appraised for fidelity to the IPS by two experts, using a standardised assessment tool the IPS fidelity scale and the team has received ongoing training and regular caseload supervision to integrate evidence-based occupational therapy into practice. The experts appraising the service are independent of both the clinical service and the proposed research.\n\nThe established VRS provides an assessment and intervention for people with complex mental health problems. A dataset has been routinely collected over several years which is currently used to evaluate the service.\n\nTo address potential limitations of secondary data analysis the researcher has an established relationship with clinicians in the VRS and was involved in the selection of routine measures now used to evaluate the service. It is, therefore, possible to be confident that a consistent and standard dataset is available for analysis. Ongoing training and consultation have been provided by the researcher to the clinical service to ensure the data quality.\n\nData Collection The data will be managed and transferred by a trained researcher on site at both services.Data will be robustly anonymised prior to transfer. Data will be transferred from NHS secure network to secure network within Queen Margaret University using a secure email service approved by the Department of Health.\n\nThe dataset comprises; Research identification (ID) code Gender Age on Admission Ethnicity Marital Status Living situation (alone/shared/supported accommodation) Quintile range of Scottish Index of Multiple Deprivation Educational attainment Previous employment ICD10 Worker role interview items Date of assessment WRI Assesses Abilities \\& Limitations WRI Expectation of Success in Work WRI Takes Responsibility WRI Commitment to Work WRI Work-Related Goals WRI Enjoys Work WRI Pursues Interests WRI Appraises Work Expectations WRI Influence of Other Roles WRI Work Habits WRI Daily Routines WRI Adapts Routine to Minimize Difficulties WRI Perception of Physical Work Setting WRI Perception of Family and Peers WRI Perception of Boss and/or Company WRI Perception of Co-workers Employment goal Date of final goal review Outcome of goal (successful/ unsuccessful in attaining employment)\n\nSample; Based on the guideline of a minimum of 10 events per predictor variable, a sample size of 200 would allow for the robust estimation of 8 variables in the model.\n\nAnalysis Plan The collected data will be subject to analysis with the use of multiple logistic regression using the R data analysis software. Multiple logistic regression will allow the construction of models which examine the effects of psychosocial predictors on the probability of a person with complex mental health problems attaining paid employment. Possible confounds which may influence outcomes will be controlled for (e.g. age, gender, educational achievement, history of employment). Interpretation of the analysis will be shared and discussed with clinicians who are expert in their field to ensure that findings are considered from both a statistical significance and clinical significance position."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Complex mental health problems; unemployed', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* self-referred to vocational rehabilitation service\n* goal of open paid employment or education\n* supported by community mental health teams\n* capacity to consent\n\nExclusion Criteria:\n\n* Lack capacity for informed consent.\n* Refusal or withdrawal of informed consent\n* Incomplete initial assessment data\n* Withdrawal from participation in service prior to intervention'}, 'identificationModule': {'nctId': 'NCT04083404', 'briefTitle': 'Investigating Psychosocial Predictors & Employment Outcomes of Enhanced IPS Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Queen Margaret University'}, 'officialTitle': 'Investigating Psychosocial Predictors & Employment Outcomes of Enhanced IPS Intervention A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'TS0001'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kirsty Forsyth, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Queen Margaret University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'all IPD that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Margaret University', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS Lothian', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Research Fellow', 'investigatorFullName': 'Susan Prior', 'investigatorAffiliation': 'Queen Margaret University'}}}}