Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT01742351
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2012-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-based Cognitive Behaviour Therapy (CBT) for Persons Diagnosed With Bipolar II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-02', 'studyFirstSubmitDate': '2012-11-16', 'studyFirstSubmitQcDate': '2012-12-03', 'lastUpdatePostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in score on the Montgomery-Åsberg Depression Rating Scale - Self rated (MADRS-S) between baseline and post treatment', 'timeFrame': '9 weeks', 'description': 'A nine item questionnaire of depressive symptoms'}], 'secondaryOutcomes': [{'measure': 'Change in the score on the Affective Self Rating Scale (AS-18-M) between baseline and post treatment', 'timeFrame': '9 weeks', 'description': 'A nine item subscale of the AS-18 measuring symptoms of mania/hypomania.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bipolar Disorder, Type II']}, 'referencesModule': {'references': [{'pmid': '25908235', 'type': 'DERIVED', 'citation': 'Hollandare F, Eriksson A, Lovgren L, Humble MB, Boersma K. Internet-Based Cognitive Behavioral Therapy for Residual Symptoms in Bipolar Disorder Type II: A Single-Subject Design Pilot Study. JMIR Res Protoc. 2015 Apr 23;4(2):e44. doi: 10.2196/resprot.3910.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to test the feasibility and acceptability of internet-based Cognitive Behaviour Therapy (CBT) for persons diagnosed with bipolar disorder, type II. The idea is to treat residual depressive symptoms as well as using psychoeducation to improve their prognosis. Each participant will have a personal therapist that will provide guidance and support throughout the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of bipolar disorder type II\n* Mild to moderate depressive symptoms\n* 18 years of age\n* Stable medication with a mood stabiliser\n* Access to the internet\n\nExclusion Criteria:\n\n* Diagnosis of psychosis\n* Having received psychiatric in-patient care during the past year\n* Ongoing psychotherapy\n* Previous manic episode\n* Previous suicide attempt\n* Previous parasuicidal behavior documented in patient record (e.g. self-injury)'}, 'identificationModule': {'nctId': 'NCT01742351', 'briefTitle': 'Internet-based Cognitive Behaviour Therapy (CBT) for Persons Diagnosed With Bipolar II', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Örebro County Council'}, 'officialTitle': 'Internet-based Cognitive Behaviour Therapy for Persons Diagnosed With Bipolar II - a Pilot Study', 'orgStudyIdInfo': {'id': '39:2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Guided internet-based cognitive behavior therapy (CBT)', 'interventionNames': ['Behavioral: Guided internet-based cognitive behavior therapy']}], 'interventions': [{'name': 'Guided internet-based cognitive behavior therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Guided internet-based cognitive behavior therapy (CBT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '701 16', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'Psychiatric Research Centre', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'overallOfficials': [{'name': 'Fredrik Holländare, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Health and Medical Science, Psychiatric Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Örebro County Council', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'School of Law, Psychology and Social Work, Örebro University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Psychologist, PhD', 'investigatorFullName': 'Fredrik Holländare', 'investigatorAffiliation': 'Örebro County Council'}}}}