Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-04 @ 2:58 PM
Study NCT ID:
NCT02519569
Status:
UNKNOWN
Last Update Posted:
2015-08-11
First Post:
2015-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-based Intervention for Complicated Grief: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-06', 'studyFirstSubmitDate': '2015-08-06', 'studyFirstSubmitQcDate': '2015-08-06', 'lastUpdatePostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from pretest to posttest in symptoms of complicated grief', 'timeFrame': '6 weeks'}, {'measure': 'Change from pretest to follow-up (1) in symptoms of complicated grief', 'timeFrame': '18 weeks'}, {'measure': 'Change from pretest to follow-up (2) in symptoms of complicated grief', 'timeFrame': '30 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from pretest to posttest in posttraumatic growth', 'timeFrame': '6 weeks'}, {'measure': 'Change from pretest to follow-up (1) in posttraumatic growth', 'timeFrame': '18 weeks'}, {'measure': 'Change from pretest to follow-up (2) in posttraumatic growth', 'timeFrame': '30 weeks'}, {'measure': 'Change from pretest to posttest in quality of life', 'timeFrame': '6 weeks'}, {'measure': 'Change from pretest to follow-up (1) in quality of life', 'timeFrame': '18 weeks'}, {'measure': 'Change from pretest to follow-up (2) in quality of life', 'timeFrame': '30 weeks'}, {'measure': 'Change from pretest to posttest in depression', 'timeFrame': '6 weeks'}, {'measure': 'Change from pretest to follow-up (1) in depression', 'timeFrame': '18 weeks'}, {'measure': 'Change from pretest to follow-up (2) in depression', 'timeFrame': '30 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Complicated Grief']}, 'descriptionModule': {'briefSummary': 'A considerable proportion of bereaved individuals experience chronic and disabling grief (so-called complicated or prolonged grief). Complicated grief is associated with severe mental and physical health problems as well as impaired social and occupational functioning. Interventions based on cognitive-behavioral therapy and applied via the internet have shown to be efficacious for this condition, but have not yet been adapted and evaluated in Norway. The aim of the current study is to adapt an internet-based cognitive-behavioral intervention for complicated grief and evaluate its effectiveness as a pilot study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Complicated grief\n* Internet access\n* Fluent in Norwegian\n* No concomitant psychological treatment\n\nExclusion Criteria:\n\n* Severe depression\n* Psychotic symptoms\n* Dissociation\n* Suicidality'}, 'identificationModule': {'nctId': 'NCT02519569', 'briefTitle': 'Internet-based Intervention for Complicated Grief: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Tromso'}, 'officialTitle': 'Internet-based Intervention for Complicated Grief: A Pilot Study', 'orgStudyIdInfo': {'id': '2015/388(REK)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Internet-based cognitive-behavioral therapy for complicated grief', 'interventionNames': ['Other: Internet-based cognitive-behavioral therapy']}], 'interventions': [{'name': 'Internet-based cognitive-behavioral therapy', 'type': 'OTHER', 'description': 'The intervention consists of ten writing assignments', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jens C. Thimm, PhD', 'role': 'CONTACT', 'email': 'jens.thimm@uit.no', 'phone': '90021044'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tromso', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jens Thimm', 'investigatorAffiliation': 'University of Tromso'}}}}