Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2026-02-06 @ 12:27 AM
Study NCT ID:
NCT03343457
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2017-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Return To Work for People on Long Term Sick Leave
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2012-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-15', 'studyFirstSubmitDate': '2017-10-30', 'studyFirstSubmitQcDate': '2017-11-14', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Return to work (RTW)', 'timeFrame': 'One year', 'description': 'Return to work measured as self-reported change in working hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety', 'Chronic Pain'], 'conditions': ['Anxiety', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '39709368', 'type': 'DERIVED', 'citation': 'Berglund E, Anderzen I, Helgesson M, Lytsy P, Andersen A. Work participation after receiving multidisciplinary treatment or acceptance and commitment therapy intervention for return to work: long-term follow-up of a randomized controlled trial among sick-listed individuals with mental disorders and/or chronic pain. BMC Public Health. 2024 Dec 21;24(1):3558. doi: 10.1186/s12889-024-21116-1.'}]}, 'descriptionModule': {'briefSummary': "Vitalis was a randomized controlled intervention study that addressed women on long-term sick leave in Uppsala County. Participants were on sick leave due to mental illness and/or pain and were expected to reach the time limit within the in health insurance. Of the total of 947 eligible reaching the time limit during 2010-2012 648 persons met the projects inclusion- and exclusion criteria and were invited to participate. Of these, 327 persons (50.4%) gave informed consent and was thereafter randomly assigned one of the following groups: 1) multimodal treatment team (TEAM) 2) psychotherapy with Acceptance and Commitment Therapy (ACT), or 3) control group. The main purpose of the study was to facilitate the return to work (preventing a return to the public health insurance) and to improve participants' health during the project period of one year.", 'detailedDescription': "Vitalis was a randomized controlled intervention study that addressed women on long-term sick leave in Uppsala County. Participants were on sick leave due to mental illness and/or pain and were expected to reach the time limit within the in health insurance. Of the total of 947 eligible reaching the time limit during 2010-2012 648 persons met the projects inclusion- and exclusion criteria and were invited to participate. Of these, 327 persons (50.4%) gave informed consent and was thereafter randomly assigned one of the following groups: 1) multimodal treatment team (TEAM) 2) psychotherapy with Acceptance and Commitment Therapy (ACT), or 3) control group. The main purpose of the study was to facilitate the return to work (preventing a return to the public health insurance) and to improve participants' health during the project period of one year.\n\nThe participants of the TEAM group received individual meetings/assessments with a doctor, psychologist, occupational therapist and social worker, each assessing the participant's problems in relation to the return to work goal. The TEAM then worked out an individualized plan of actions/treatments, which then was presented to the participant. Suggested and accepted actions were psychotherapy (60%, average 9.2 sessions); Occupational Therapist (72%, average 3.7 sessions); social worker (36%, average 6.5 sessions) and further medical investigations/referrals initiated by physicians (41%).\n\nIn the ACT group all participants received psychotherapy with ACT with an average of 10.0 sessions (range 1-23) during the project year.\n\nIn addition to the medical assessment/treatments all participants in the intervention groups also participated in scheduled collaboration meetings with representatives from the health insurance agency and employment office in order to establish an agreement and justification on the rehabilitation goals. The participant and a health professional from the project participated in these collaborations meetings.\n\nDuring the project year the participants filled in questionnaire at three points in time in which they rated their views on returning to work as well as various aspects of their health. Data whether the participants had returned to the health insurance as well as the number of reimbursed days during the first years, was collected from the health insurance register after one year."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* On sick leave for mental illness and/or chronic pain\n\nExclusion Criteria:\n\n* High risk for suicide\n* Ongoing alcohol/substance abuse\n* Major mental illness (schizophrenia, bipolar disorder type I, severe social dysfunction/personality disorder)\n* Participation in psychotherapy or another vocational rehabilitation program.'}, 'identificationModule': {'nctId': 'NCT03343457', 'acronym': 'Vitalis', 'briefTitle': 'Return To Work for People on Long Term Sick Leave', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'A Randomized Intervention and Coordination Program Aiming at Return To Work for Women With Long Term Sick Leave', 'orgStudyIdInfo': {'id': 'VITALIS 2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acceptance Commitment Therapy', 'description': 'Acceptance Commitment Therapy. Cognitive therapy', 'interventionNames': ['Behavioral: Cognitive therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Multidisciplinary assessment', 'description': 'Assessment of a team. Cognitive therapy', 'interventionNames': ['Behavioral: Cognitive therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control group'}], 'interventions': [{'name': 'Cognitive therapy', 'type': 'BEHAVIORAL', 'otherNames': ['ACT, multidisciplinary assessment'], 'armGroupLabels': ['Acceptance Commitment Therapy', 'Multidisciplinary assessment']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Stockholm', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}