Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-30 @ 6:13 AM
Study NCT ID:
NCT01540357
Status:
COMPLETED
Last Update Posted:
2013-09-27
First Post:
2012-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness-based Therapy in Chronic Tinnitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-26', 'studyFirstSubmitDate': '2012-02-22', 'studyFirstSubmitQcDate': '2012-02-27', 'lastUpdatePostDateStruct': {'date': '2013-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in tinnitus complaints as measured by the German version of the Tinnitus Questionnaire (TQ)(Baseline versus week 9)', 'timeFrame': 'Baseline to Week 9'}], 'secondaryOutcomes': [{'measure': 'Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 7)', 'timeFrame': 'Week 7'}, {'measure': 'Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 9)', 'timeFrame': 'Week 9'}, {'measure': 'Change in rating scores of German versions of the Tinnitus Handicap Inventory (Hallam) (Baseline versus week 24)', 'timeFrame': 'Week 24'}, {'measure': 'Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 7)', 'timeFrame': 'Week 7'}, {'measure': 'Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 9)', 'timeFrame': 'Week 9'}, {'measure': 'Change in rating scores of German version of the tinnitus questionnaire (Goebel/Hiller) (Baseline versus week 24)', 'timeFrame': 'Week 24'}, {'measure': 'Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 7)', 'timeFrame': 'Week 7'}, {'measure': 'Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 9)', 'timeFrame': 'Week 9'}, {'measure': 'Change in rating scores of German version of the Beck Depression Inventory (Baseline versus week 24)', 'timeFrame': 'Week 24'}, {'measure': 'Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 7)', 'timeFrame': 'Week 7'}, {'measure': 'Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 9)', 'timeFrame': 'Week 9'}, {'measure': 'Change in rating scores of German version of the tinnitus numeric rating scales (loudness, discomfort, annoyance, distractibility, unpleasantness) (Baseline versus week 24)', 'timeFrame': 'Week 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mindfulness-based therapy', 'chronic tinnitus;'], 'conditions': ['Chronic Tinnitus']}, 'referencesModule': {'references': [{'pmid': '8175381', 'type': 'BACKGROUND', 'citation': 'Goebel G, Hiller W. [The tinnitus questionnaire. A standard instrument for grading the degree of tinnitus. Results of a multicenter study with the tinnitus questionnaire]. HNO. 1994 Mar;42(3):166-72. German.'}, {'pmid': '23186556', 'type': 'RESULT', 'citation': 'Kreuzer PM, Goetz M, Holl M, Schecklmann M, Landgrebe M, Staudinger S, Langguth B. Mindfulness-and body-psychotherapy-based group treatment of chronic tinnitus: a randomized controlled pilot study. BMC Complement Altern Med. 2012 Nov 28;12:235. doi: 10.1186/1472-6882-12-235.'}]}, 'descriptionModule': {'briefSummary': 'In the present randomized waiting-list-controlled study the investigators examined a specific manualized mindfulness-based therapeutic approach in the treatment of chronic tinnitus.', 'detailedDescription': 'In the current randomized waiting-list-controlled pilot study, we investigate a new manualized therapeutic approach, which is based on mindfulness- and body-psychotherapy and which has been specifically developed for the treatment of tinnitus patients (Tinnitus Atemtherapie; http://www.maria-holl.de/). Essential components of the treatment program include mindfulness, meditation, selfmassage, and breathing exercises. These components are intended to help patients use their inner resources to accept responsibility for themselves, become more self-sufficient and develop symptom acceptance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic tinnitus (duration ≥ 6 months)\n* German speaking\n* Subjective tinnitus\n\nExclusion Criteria:\n\n* Instable medical conditions\n* Objective tinnitus'}, 'identificationModule': {'nctId': 'NCT01540357', 'briefTitle': 'Mindfulness-based Therapy in Chronic Tinnitus', 'organization': {'class': 'OTHER', 'fullName': 'University of Regensburg'}, 'officialTitle': 'Mindfulness-based Therapy For the Treatment of Chronic Tinnitus: A Randomized Controlled Pilot Study', 'orgStudyIdInfo': {'id': 'MBT-TIN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness-based therapy', 'description': 'Treatment was performed as group therapy at two training weekends which were separated by an interval of 7 weeks (eleven hours/weekend) and in four further two-hour sessions (week 2, 9, 18 and 22).', 'interventionNames': ['Behavioral: Mindfulness-based therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment after waiting time', 'description': 'Treatment was performed after completion of the active arm.', 'interventionNames': ['Behavioral: Treatment after waiting time']}], 'interventions': [{'name': 'Mindfulness-based therapy', 'type': 'BEHAVIORAL', 'description': 'Treatment was performed as group therapy at two training weekends which were separated by an interval of 7 weeks (eleven hours/weekend) and in four further two-hour sessions (week 2, 9, 18 and 22).', 'armGroupLabels': ['Mindfulness-based therapy']}, {'name': 'Treatment after waiting time', 'type': 'BEHAVIORAL', 'description': 'Treatment was performed after completion of the active arm.', 'armGroupLabels': ['Treatment after waiting time']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93153', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'University of Regensburg - Dep. of Psychiatry', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}], 'overallOfficials': [{'name': 'Berthold Langguth, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Regensburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Regensburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Berthold Langguth, MD, Ph.D.', 'investigatorAffiliation': 'University of Regensburg'}}}}