Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT05060393
Status:
UNKNOWN
Last Update Posted:
2021-09-29
First Post:
2021-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Mindfulness-based Mobile Application Use in Patients With Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000099025', 'term': 'Mindfulness-Based Cognitive Therapy'}], 'ancestors': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-17', 'studyFirstSubmitDate': '2021-09-08', 'studyFirstSubmitQcDate': '2021-09-17', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline self reported Depression Severity', 'timeFrame': '30 days', 'description': 'Beck Depression Inventory'}, {'measure': 'Change from Baseline Depression Severity', 'timeFrame': '30 days', 'description': 'Hamilton Depression Rating Scale'}], 'secondaryOutcomes': [{'measure': 'Change from baseline heart rate', 'timeFrame': '30 days', 'description': 'Change in resting heart rate'}, {'measure': 'Change from baseline blood pressure', 'timeFrame': '30 days', 'description': 'Change in systolic blood pressure'}, {'measure': 'Change from baseline respiratory rate', 'timeFrame': '30 days', 'description': 'Change in resting respiratory rate'}, {'measure': 'Change from baseline tobacco consumption', 'timeFrame': '30 days', 'description': 'Change in daily tobacco consumption'}, {'measure': 'Change from baseline alcohol consumption', 'timeFrame': '30 days', 'description': 'Change in weekly alcohol consumption'}, {'measure': 'Change in consumption of anxiolytics', 'timeFrame': '30 days', 'description': 'Change in daily use of anxiolytic drugs'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '35357325', 'type': 'DERIVED', 'citation': 'Sarlon J, Doll JPK, Schmassmann A, Brand S, Ferreira N, Muehlhauser M, Urech-Meyer S, Schweinfurth N, Lang UE, Bruehl AB. Effectiveness of a Mindfulness-Based Mobile Application for the Treatment of Depression in Ambulatory Care: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Mar 31;11(3):e33423. doi: 10.2196/33423.'}]}, 'descriptionModule': {'briefSummary': 'The presented randomized-controled study aim to assess the use of internet-based mindfulness intervention via mobile application for 30 days in patients with Major Depressive Disorder (MDD)', 'detailedDescription': 'Mindfulness-based interventions (MBI) proved to be effective in relapse prevention in MDD. Next, MBI in form of free mobile applications can be an effective augmentation of the treatment as usual (TAU) and can fill a gap in the ambulatory care. Given this background, the aim of this randomized controlled study is to assess the effectiveness of additional MBI via mobile app on the symptom severity and stress levels, compared to TAU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Depression, current ill\n\nExclusion Criteria:\n\n* acute alcohol- and drug dependency, schizophrenia or psychotic disorder, severe somatic illnes, not having smartphone or not willing to use mobile application'}, 'identificationModule': {'nctId': 'NCT05060393', 'briefTitle': 'Efficacy of Mindfulness-based Mobile Application Use in Patients With Depressive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Basel'}, 'officialTitle': 'Efficacy of Mindfulness-based Mobile Application Use in Patients With Depressive Disorder', 'orgStudyIdInfo': {'id': '202100452'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Daily use of mindfulness-based mobile application for 30 days.', 'interventionNames': ['Behavioral: Mindfulness-based cognitive therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Treatment as usual'}], 'interventions': [{'name': 'Mindfulness-based cognitive therapy', 'type': 'BEHAVIORAL', 'description': 'Mobile application, mindfulness-based therapy', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Jan Sarlon', 'role': 'CONTACT', 'email': 'jan.sarlon@upk.ch', 'phone': '+41613255381'}], 'facility': 'Jan Sarlon', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Jan Sarlon', 'role': 'CONTACT', 'email': 'jan.sarlon@upk.ch', 'phone': '+41613255381'}], 'overallOfficials': [{'name': 'Jan Sarlon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Basel'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Immediately following publication and ending 5 years following article publication.', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial will be shared, after deidentification.', 'accessCriteria': 'Researchers who provide a methodologically sound proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Basel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jan Sarlon', 'investigatorAffiliation': 'University of Basel'}}}}