Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT01591720
Status:
COMPLETED
Last Update Posted:
2012-05-04
First Post:
2012-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tailored Internet-delivered Cognitive Behaviour Therapy in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'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': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-02', 'studyFirstSubmitDate': '2012-04-18', 'studyFirstSubmitQcDate': '2012-05-02', 'lastUpdatePostDateStruct': {'date': '2012-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Health Questionnaire 9 (PHQ-9)', 'timeFrame': '2 weeks before treatment starts'}, {'measure': 'Patient Health Questionnaire 9 (PHQ-9)', 'timeFrame': 'Weekly measures during treatment (for up to 16 weeks)'}, {'measure': 'Patient Health Questionnaire 9 (PHQ-9)', 'timeFrame': 'At treatment termination (after a maximum of 16 weeks)'}, {'measure': 'Generalised Anxiety Disorder Assessment 7 (GAD-7)', 'timeFrame': '2 weeks before treatment starts'}, {'measure': 'Generalised Anxiety Disorder Assessment 7 (GAD-7)', 'timeFrame': 'Weekly measures during treatment (for up to 16 weeks)'}, {'measure': 'Generalised Anxiety Disorder Assessment 7 (GAD-7)', 'timeFrame': 'At treatment termination (after a maximum of 16 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression', 'Anxiety Disorders']}, 'descriptionModule': {'briefSummary': 'A tailored Internet-based cognitive-behavioural intervention is tested within a primary care clinic. Weekly measures of symptoms of depression and anxiety are obtained. Significant within-group effects are expected.', 'detailedDescription': 'This Internet-based cognitive-behavioural therapy intervention contains 8-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are "prescribed" following the diagnostic interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.\n\nThe intervention is tested within a primary care clinic. Weekly measures of symptoms of depression and anxiety are obtained.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptoms of depression and anxiety\n\nExclusion Criteria:\n\n* Severe depression (based on interview)\n* Severe psychiatric condition (e.g. psychosis or bipolar disorder)\n* Suicidal (measured in diagnostic interview)'}, 'identificationModule': {'nctId': 'NCT01591720', 'acronym': 'TAYLOR2', 'briefTitle': 'Tailored Internet-delivered Cognitive Behaviour Therapy in Primary Care', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Effectiveness Testing of a Tailored Internet-delivered Cognitive Behaviour Therapy Treatment for Symptoms of Depression, Anxiety and Comorbid Problems', 'orgStudyIdInfo': {'id': 'GA-VR-DEP-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tailored Internet-delivered CBT', 'description': 'The intervention is delivered within a primary care clinic.', 'interventionNames': ['Behavioral: Tailored Internet-based CBT for depression and anxiety']}], 'interventions': [{'name': 'Tailored Internet-based CBT for depression and anxiety', 'type': 'BEHAVIORAL', 'description': 'This Internet-based CBT intervention contains 8-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are "prescribed" following the diagnostic interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.', 'armGroupLabels': ['Tailored Internet-delivered CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58183', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Linköping University, Department of Behavioral Sciences and Learning', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Gerhard Andersson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Behavioral Sciences and Learning, Linköping University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical Psychology', 'investigatorFullName': 'Gerhard Andersson', 'investigatorAffiliation': 'Linkoeping University'}}}}