Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-30 @ 2:10 PM
Study NCT ID:
NCT00845260
Status:
COMPLETED
Last Update Posted:
2009-02-18
First Post:
2009-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016584', 'term': 'Panic Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-17', 'studyFirstSubmitDate': '2009-02-17', 'studyFirstSubmitQcDate': '2009-02-17', 'lastUpdatePostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Panic Disorder Severity Scale (PDSS)', 'timeFrame': 'Pre, post at 6-month follow-up'}], 'secondaryOutcomes': [{'measure': 'Montgomery-Åsberg Depression Rating Scale (MADRS) Anxiety Sensitivity Index (ASI) Sheehan Disability Scale (SDS)', 'timeFrame': 'Pre, post and 6-month follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Panic Disorder']}, 'referencesModule': {'references': [{'pmid': '21110842', 'type': 'DERIVED', 'citation': 'Lonsdorf TB, Ruck C, Bergstrom J, Andersson G, Ohman A, Lindefors N, Schalling M. The COMTval158met polymorphism is associated with symptom relief during exposure-based cognitive-behavioral treatment in panic disorder. BMC Psychiatry. 2010 Nov 26;10:99. doi: 10.1186/1471-244X-10-99.'}, {'pmid': '20598127', 'type': 'DERIVED', 'citation': 'Bergstrom J, Andersson G, Ljotsson B, Ruck C, Andreewitch S, Karlsson A, Carlbring P, Andersson E, Lindefors N. Internet-versus group-administered cognitive behaviour therapy for panic disorder in a psychiatric setting: a randomised trial. BMC Psychiatry. 2010 Jul 2;10:54. doi: 10.1186/1471-244X-10-54.'}]}, 'descriptionModule': {'briefSummary': 'Panic Disorder with or without agoraphobia (PD/A) is a common, and unless it is treated, often chronic psychiatric disorder. The are effective pharmacological as well as psychological treatments for PD/A. Because of the lack of availability of the most effective psychological treatment, cognitive behavior therapy (CBT), self-help based CBT treatments have been developed. One of those are Internet-based CBT. The aim of this study is to compare the effectiveness of Internet and group CBT for PD/A in a regular psychiatric setting. 113 patients are consecutively and randomly assigned to either treatment (both lasting 10 weeks). The main outcome measure is the Panic Disorder Severity Scale(PDSS). The study hypothesis is that treatments will show equal effectiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary Panic Disorder with or without Agoraphobia (PD/A)\n\nExclusion Criteria:\n\n* active substance abuse\n* physiological etiology of panic symptoms\n* under 18 years of age\n* severe depression or suicidal ideation.\n* if on drugs for PD, not having had a constant dosage for 2 months\n* undergoing other cognitive behavioral treatment'}, 'identificationModule': {'nctId': 'NCT00845260', 'acronym': 'IP2', 'briefTitle': 'Internet-Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Internet- Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder in a Psychiatric Setting: A Randomized Equivalence Trial', 'orgStudyIdInfo': {'id': 'IP2'}, 'secondaryIdInfos': [{'id': 'Dnr 04-034/4'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet CBT', 'description': 'Internet-based cognitive behavior therapy (CBT).', 'interventionNames': ['Behavioral: Internet-based cognitive behavior therapy (CBT).']}, {'type': 'EXPERIMENTAL', 'label': 'Group CBT', 'description': 'Group cognitive behavior therapy (CBT).', 'interventionNames': ['Behavioral: Group CBT']}], 'interventions': [{'name': 'Internet-based cognitive behavior therapy (CBT).', 'type': 'BEHAVIORAL', 'description': 'Self-help program and guidance by psychologist via e-mail during 10 weeks.', 'armGroupLabels': ['Internet CBT']}, {'name': 'Group CBT', 'type': 'BEHAVIORAL', 'description': 'Group cognitive behavior therapy (CBT) during 10 weeks.', 'armGroupLabels': ['Group CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Nils Lindefors, MD, PhD, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Stockholm', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Nils Lindefors, MD, PHD, professor', 'oldOrganization': 'Karolinska Institutet, Stockholm County Council'}}}}