Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT05085756
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2021-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transdiagnostic Internet Intervention to Improve Mental Health Among University Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C553190', 'term': 'bbc3 protein, zebrafish'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2021-10-06', 'studyFirstSubmitQcDate': '2021-10-07', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PHQ-9 for depression', 'timeFrame': 'last 2 weeks', 'description': '9 items measuring depressive symptoms'}, {'measure': 'GAD-7 for anxiety', 'timeFrame': 'last 2 weeks', 'description': '7 items measuring anxiety symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychological Disorder']}, 'referencesModule': {'references': [{'pmid': '34418224', 'type': 'BACKGROUND', 'citation': 'Andersson C, Bendtsen M, Lindfors P, Molander O, Lindner P, Topooco N, Engstrom K, Berman AH. Does the management of personal integrity information lead to differing participation rates and response patterns in mental health surveys with young adults? A three-armed methodological experiment. Int J Methods Psychiatr Res. 2021 Dec;30(4):e1891. doi: 10.1002/mpr.1891. Epub 2021 Aug 21.'}, {'pmid': '38429834', 'type': 'BACKGROUND', 'citation': 'Berman AH, Topooco N, Lindfors P, Bendtsen M, Lindner P, Molander O, Kraepelien M, Sundstrom C, Talebizadeh N, Engstrom K, Vlaescu G, Andersson G, Andersson C. Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial. Trials. 2024 Mar 1;25(1):158. doi: 10.1186/s13063-024-07986-1.'}]}, 'descriptionModule': {'briefSummary': 'This study offers transdiagnostic CBT-based treatment for symptoms of depression and anxiety to university students who have previously responded to the WHO-WMH-ICS survey.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PHQ-9 cutoff for mild depression\n* GAD-7 cutoff for mild anxiety\n\nExclusion Criteria:\n\n* Suicidal ideation or plans\n* Severe levels of mental ill-health'}, 'identificationModule': {'nctId': 'NCT05085756', 'briefTitle': 'Transdiagnostic Internet Intervention to Improve Mental Health Among University Students', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Swedish Partnership in the WHO-WMH-ICS Study on National Mapping and E-health Interventions for Mental Health Issues Among University Students: Psychological Internet Treatment for Improved Mental Health', 'orgStudyIdInfo': {'id': '2021-03599'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Guided treatment', 'description': '8-week transdiagnostic CBT with written guidance from M.Sc-level students under supervision.', 'interventionNames': ['Behavioral: Puma']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Unguided treatment', 'description': '8-week transdiagnostic CBT without guidance.', 'interventionNames': ['Behavioral: Puma']}, {'type': 'OTHER', 'label': 'Waitlist', 'description': '8-week transdiagnostic CBT without guidance, made available 6 months after recruitment.', 'interventionNames': ['Behavioral: Puma']}], 'interventions': [{'name': 'Puma', 'type': 'BEHAVIORAL', 'description': 'One psychoeducation module followed by two transdiagnostic modules tailored to primary depression or anxiety symptoms, followed by three participant-choice modules, and ending with two transdiagnostic modules.', 'armGroupLabels': ['Guided treatment', 'Unguided treatment', 'Waitlist']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75105', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Anne H Berman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Psychology, Uppsala University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a future plan. Outcome data will be shared as appropriate, but primarily within the WHO-WMH-ICS consortium.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, {'name': 'Malmö University', 'class': 'OTHER'}, {'name': 'Stockholm University', 'class': 'OTHER'}, {'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Anne H Berman', 'investigatorAffiliation': 'Uppsala University'}}}}