Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT03158194
Status:
COMPLETED
Last Update Posted:
2018-03-08
First Post:
2017-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Behavior Therapy for Anxiety-related Asthma in Adults.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-subject multiple baseline design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-07', 'studyFirstSubmitDate': '2017-05-16', 'studyFirstSubmitQcDate': '2017-05-16', 'lastUpdatePostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Penn State Worry Questionnaire', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Change in subjective worry measured with a self-rating scale weekly during 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.'}], 'secondaryOutcomes': [{'measure': 'Anxiety Sensitivity Index-3', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Change in anxiety sensitivity measured with a self-rating scale weekly during 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.'}, {'measure': 'Short Health Anxiety Inventory (SHAI)', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Change in health anxiety measured with a self-rating scale weekly during 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.'}, {'measure': 'Asthma Quality of Life Questionnaire', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Change in asthma-related quality of life measured with a self-rating scale at pretreatment and at 10 to 12 weeks post treatment for analysis of effect.'}, {'measure': 'Asthma control test', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Change in asthma control measured with a self-rating scale daily during weekly 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.'}, {'measure': 'Catastrophizing about asthma Scale', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Change in catastrophizing cognitions about asthma measured with a self-rating scale weekly during 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.'}, {'measure': 'Perceived Stress Scale', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Change in perceived stress measured with a self-rating scale weekly 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.'}, {'measure': 'Patient Health Questionnaire', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Change in depression measured with a self-rating scale at baseline and at 10 to 12 weeks post treatment for analysis of effect.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety', 'Stress', 'Asthma'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This is a study to develop a protocol on Cognitive behavior therapy (CBT) for asthma-related anxiety that in a consecutive study can be translated to internet-delivered CBT.', 'detailedDescription': 'Asthma is one of the most common chronic diseases around the world, with a high prevalence of anxiety disorders. Cognitive behaviour therapy (CBT) has been shown to increase psychological well-being for anxiety-related asthma. Our primary aim is to develop a standardized CBT protocol for asthma-related anxiety that can be transferred to internet-delivered CBT. Ten participants will be included in a single-subject multiple baseline design. They will all receive 10-12 sessions of CBT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* asthma diagnosed by a physician\n* anxiety or stress related to asthma\n\nExclusion Criteria:\n\n* severe psychiatric disorder (e.g. psychotic disorder, addiction disorder, suicidal ideation).'}, 'identificationModule': {'nctId': 'NCT03158194', 'briefTitle': 'Cognitive Behavior Therapy for Anxiety-related Asthma in Adults.', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Cognitive Behavior Therapy for Anxiety-related Asthma in Adults.', 'orgStudyIdInfo': {'id': 'MANTRA 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT for anxiety-related asthma', 'description': 'Ten to twelve weekly sessions of CBT targeting enhanced function and decreased symptoms of anxiety.', 'interventionNames': ['Behavioral: CBT for anxiety-related asthma']}], 'interventions': [{'name': 'CBT for anxiety-related asthma', 'type': 'BEHAVIORAL', 'description': 'The specific assignments in the intervention will be based on individual behavior analysis for each participant.', 'armGroupLabels': ['CBT for anxiety-related asthma']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Catarina Almqvist Malmros, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Catarina Almqvist Malmros', 'investigatorAffiliation': 'Karolinska Institutet'}}}}