Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-02-20 @ 11:42 AM
Study NCT ID:
NCT03748394
Status:
UNKNOWN
Last Update Posted:
2018-11-20
First Post:
2016-12-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interventions to Facilitate Working While Depressed and Anxious
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-19', 'studyFirstSubmitDate': '2016-12-28', 'studyFirstSubmitQcDate': '2018-11-19', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Work ability', 'timeFrame': 'change in score from baseline to 8 weeks', 'description': 'Work Ability Index'}], 'secondaryOutcomes': [{'measure': 'Depression severity', 'timeFrame': 'change in score from baseline to 8 weeks', 'description': 'Montgomery Asberg Depression Rating Scale'}, {'measure': 'Anxiety symptoms', 'timeFrame': 'change in score from baseline to 8 weeks', 'description': 'Beck Anxiety Index'}, {'measure': 'Mental wellbeing', 'timeFrame': 'change in score from baseline to 8 weeks', 'description': 'WHO-5 Mental Wellbeing Index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Work capacity evaluation', 'Common mental disorders', 'Occupational therapy', 'Physical Therapy Modalities'], 'conditions': ['Work Capacity']}, 'descriptionModule': {'briefSummary': 'The study compares the effects of two add-on interventions in primary care rehabilitation, on work ability and psychological health, in workers with common mental disorders. One intervention consists of a person-centered plan using work-directed treatment modules of occupational therapy and physical therapy, during 8 weeks. The other intervention consists of supported physical activity during 8 weeks. The primary outcome is work ability, measured by the work ability index and days on sick leave.', 'detailedDescription': "Common mental disorders (CMD), including mild to moderate depression, anxiety disorders and exhaustion disorder, are a major cause of sick leave and work disability. Compared to other disorders, work-related problems associated with CMD is sparsely explored. While recommended treatments, such as antidepressants or cognitive behavioral therapy have effects on psychiatric symptoms, the effect on work capacity is unclear, suggesting a need for alternative interventions.\n\nThe aim of this study is to evaluate the effects of an add-on work-directed intervention in primary care rehabilitation, compared to a physical activity control, for persons with CMD.\n\nThe goal of the experimental condition is to enhance the participant's ability to work by creating an individually tailored plan for self-management, supported by occupational and physical therapy techniques, such as structuring daily activities, stress management or body awareness techniques. Enhancing self-management is the core of this intervention and also a new approach compared to earlier efforts to promote work capacity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unipolar depression or anxiety disorder according to the Mini Neuropsychiatric Interview (DSM-5 criteria).\n* Currently working to some extent, part time sick leave is accepted.\n\nExclusion Criteria:\n\n* Substance abuse according to the Mini interview\n* High suicide risk according to the Mini interview\n* Psychotic symptoms according to the Mini interview'}, 'identificationModule': {'nctId': 'NCT03748394', 'briefTitle': 'Interventions to Facilitate Working While Depressed and Anxious', 'organization': {'class': 'OTHER', 'fullName': 'Göteborg University'}, 'officialTitle': 'Enhancing Work Ability in Common Mental Disorders: Comparing Two Interventions in Primary Care Rehabilitation', 'orgStudyIdInfo': {'id': 'VGFOUREG-588531'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Work-directed rehabilitation', 'description': 'Work-directed, person-centered plan using modules of occupational therapy and physical therapy', 'interventionNames': ['Behavioral: Work-directed rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physical activity', 'description': 'Physical activity according to national health recommendations', 'interventionNames': ['Behavioral: Physical activity']}], 'interventions': [{'name': 'Work-directed rehabilitation', 'type': 'BEHAVIORAL', 'description': "Each participant starts with a meeting together with an occupational therapist or a physical therapist, focusing on the participant's resources and obstacles for functioning well at work. A plan is designed and carried out over 8 weeks, including 1-4 different treatment modules of occupational and physical therapy, to support the person's ability to function at work", 'armGroupLabels': ['Work-directed rehabilitation']}, {'name': 'Physical activity', 'type': 'BEHAVIORAL', 'description': 'In a meeting with a physical therapist, each participant receives advice on physical activity to support mental health, according to national recommendations. The participant is offered to train at a local gym during 8 weeks.', 'armGroupLabels': ['Physical activity']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Louise Danielsson, PhD', 'role': 'CONTACT'}], 'facility': 'Närhälsan Gibraltar Rehabmottagning', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'centralContacts': [{'name': 'Louise Danielsson, PhD', 'role': 'CONTACT', 'email': 'louise.danielsson@gu.se', 'phone': '+46702319907'}], 'overallOfficials': [{'name': 'Gunnel Hensing, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Göteborg University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göteborg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}