Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT04457635
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2020-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011613', 'term': 'Psychotherapy'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessor of primary outcome (sickness benefit) is masked for intervention allocation. Other outcome measures are assessed by patient questionnaires.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pragmatic randomized controled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-30', 'studyFirstSubmitDate': '2020-06-26', 'studyFirstSubmitQcDate': '2020-06-30', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Beck Depression Index - II (BDI)', 'timeFrame': 'baseline, 2 year follow-up', 'description': 'Score 0-63, higher scores mean worse outcome'}, {'measure': 'Beck Anxiety Index (BAI)', 'timeFrame': 'baseline, 2 year follow-up', 'description': 'Score 0-63, higher scores mean worse outcome'}, {'measure': 'Hopkins Symptoms Checklist-10', 'timeFrame': 'baseline, 2 year follow-up', 'description': 'Score 1-4, higher scores mean worse outcome'}, {'measure': 'Subjective health complaints (SHC)', 'timeFrame': 'baseline, 2 year follow-up', 'description': 'Score 0-29, higher scores mean worse outcome'}, {'measure': 'Self-efficacy (GSES)', 'timeFrame': 'baseline - 2 year follow-up', 'description': 'Score 1-4 , lower scores means worse outcome'}, {'measure': 'Lfe satisfaction (LISAT)', 'timeFrame': 'baseline - 2 year follow-up', 'description': 'Score 1-6, lower scores means worse outcome'}, {'measure': 'Illness perception (bIPC)', 'timeFrame': 'baseline - 2 year follow-up', 'description': 'Score 1-10, higher scores mean worse outcome'}, {'measure': 'Fear avoidance beliefs -work (FABQ-work)', 'timeFrame': 'baseline - 2 year follow-up', 'description': 'Score 0-7, higher scores mean worse outcome'}, {'measure': 'Global Perceived Effect', 'timeFrame': '2 year follow-up', 'description': 'Score 0-7, lower scores means worse outcome'}], 'primaryOutcomes': [{'measure': 'Change in Return to Work (RTW) to 3 months follow-up', 'timeFrame': 'baseline - 3 months', 'description': 'Transitions from baseline to 3 months follow-up in Work Participation degree'}, {'measure': 'Change in Return to Work (RTW) to 1 year follow-up', 'timeFrame': 'baseline - 1 year', 'description': 'Transitions from baseline to 1 year follow-up in Work Participation degree'}, {'measure': 'Change in Return to Work (RTW) to 2 year follow-up', 'timeFrame': 'baseline - 2 year', 'description': 'Transitions from baseline to 2 year follow-up in Work Participation degree'}], 'secondaryOutcomes': [{'measure': 'Clinical recovery', 'timeFrame': '2 years', 'description': 'A minimal score on both Beck Inventories (BDI ≤ 13 and BAI ≤ 9)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Return to Work', 'Brief Intervention'], 'conditions': ['Mental Disorder']}, 'descriptionModule': {'briefSummary': 'This study is a pragmatic randomized controlled trial (RCT) evaluating the effect of brief versus short psychotherapy in subjects with substantial mental complaints.', 'detailedDescription': 'Running evaluations of the brief intervention (BI) at our outpatient clinic preceding to this study had given us the impression that the patients obtained a more active coping style towards their health problems with consequential enhanced work participation (WP). These evaluations, in addition to our experiences in BI for low back pain (LBP) has generated the current hypothesis of this study towards WP. Yet, the sustainability of WP and long-term effects on mental health remained questionable. In this pragmatic RCT the objective was to compare brief psychotherapy with focus on normalization and coping (Brief-PsT) with short-term psychotherapy of standard duration with more extended focus (Short-PsT), as otherwise used at the Mental Health services. The primary aim of this study was to assess differences in effect on WP and the secondary aim was to assess differences in clinical response. The investigators hypothesized that in the short term, Brief-PsT could facilitate or sustain WP in a superior fashion to Short-PsT in persons who are on, or at risk of sick leave due to mental health problems. Although the investigators expected a substantial long-term rate of clinical recovery and reduction in mental health-related symptoms in both groups, the investigators had no specific hypothesis regarding the extent and direction of possible group differences in these clinical measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '67 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 'mental complaints' was the main reason for referral to the outpatient clinic\n* employed and on or at risk of sick leave\n\nExclusion Criteria:\n\n* acute or severe pathology that required greater input than the clinic could offer,\n* Sick-leave had \\> 9 months during the preceding 2 years"}, 'identificationModule': {'nctId': 'NCT04457635', 'briefTitle': "Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders.", 'organization': {'class': 'OTHER', 'fullName': 'The Hospital of Vestfold'}, 'officialTitle': "Effect of a 'Rapid-Return-to-work Program' in Mild Mental Disorders. A Randomized Controlled Trial.", 'orgStudyIdInfo': {'id': 'HVestfold'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brief psychotherapy (brief PsT)', 'description': 'The focus was on normalizing, accepting and coping with their present mental health complaints and their hindrance for work participation. Primarily, there was no intention to process previous pathogenic experiences. The standard duration was set on six sessions.', 'interventionNames': ['Behavioral: Psychotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Short psychotherapy (short-PsT)', 'description': 'With more extended focus, there was besides coping of mental health and challenges concerning WP, an emphasis on both an extensive anamnesis and possibility to establish a so-called central theme based on previous or current challenging issues such as trauma, difficult childhood conditions, and personality-related issues. Additional aims of the intervention could include reducing symptoms and problematic behaviour and an improvement of home situation, with deeper focus on cognitive maladaptive coping strategies or dynamic repetitions. The number of sessions was aimed to be 20 on average', 'interventionNames': ['Behavioral: Psychotherapy']}], 'interventions': [{'name': 'Psychotherapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Brief psychotherapy (brief PsT)', 'Short psychotherapy (short-PsT)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Aage Indahl, Prof.Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vestfol Hospital Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital of Vestfold', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor emeritus', 'investigatorFullName': 'Aage Indahl', 'investigatorAffiliation': 'The Hospital of Vestfold'}}}}