Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:18 AM
Study NCT ID:
NCT07324603
Status:
COMPLETED
Last Update Posted:
2026-01-07
First Post:
2025-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smartphone-Based vs Face-to-Face Counseling for Tinnitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-12-23', 'studyFirstSubmitQcDate': '2025-12-23', 'lastUpdatePostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tinnitus Impact', 'timeFrame': 'Baseline to 6 weeks', 'description': 'Change in tinnitus impact assessed using the Tinnitus Handicap Inventory (THI).'}], 'secondaryOutcomes': [{'measure': 'Depressive Symptoms', 'timeFrame': 'Baseline to 6 weeks', 'description': 'Change in depressive symptoms assessed using the Beck Depression Inventory (BDI).'}, {'measure': 'Sleep Quality', 'timeFrame': 'Baseline to 6 weeks', 'description': 'Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI).'}, {'measure': 'Perceived Tinnitus Severity', 'timeFrame': 'Baseline to 6 weeks', 'description': 'Change in perceived tinnitus severity assessed using a Visual Analog Scale (VAS).'}, {'measure': 'Tinnitus-Related Annoyance', 'timeFrame': 'Baseline to 6 weeks', 'description': 'Change in tinnitus-related annoyance assessed using a Visual Analog Scale (VAS).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic tinnitus', 'Counseling', 'Smartphone-based counseling', 'Digital Health', 'Mobile Application', 'Patient Education'], 'conditions': ['Chronic Tinnitus']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effectiveness of smartphone-based counseling and face-to-face counseling in adults with chronic tinnitus. Both interventions are based on the same structured counseling protocol and are delivered over a six-week period. The primary research question is whether smartphone-based counseling can achieve clinical outcomes comparable to those of traditional face-to-face counseling in reducing tinnitus-related impact and associated symptoms.', 'detailedDescription': 'This study is a randomized, parallel-group clinical trial designed to evaluate two counseling delivery formats for chronic tinnitus. Eligible adult participants with chronic subjective tinnitus are allocated to either smartphone-based counseling or face-to-face counseling. Both groups receive the same structured counseling content, with the delivery format being the only difference between interventions.\n\nThe counseling protocol focuses on tinnitus education, correction of maladaptive beliefs, and development of coping strategies. In the face-to-face group, counseling is delivered through scheduled in-person sessions using a structured educational booklet. In the smartphone-based group, the same content is delivered through a mobile application consisting of sequential modules, including assessment, education, coping strategies, and a clinician support feature.\n\nParticipants in both groups complete baseline assessments prior to counseling and follow-up evaluations at two and six weeks. The study is designed to examine whether smartphone-based counseling can achieve outcomes comparable to traditional face-to-face counseling when a unified counseling protocol is applied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults aged 18 years or older\n\nDiagnosis of chronic subjective tinnitus lasting at least 6 months\n\nCompletion of a comprehensive audiological evaluation\n\nAbility to read and understand the study materials\n\nAdequate cognitive function as determined by a Mini-Mental State Examination score of 25 or higher\n\nWillingness and ability to provide written informed consent\n\nExclusion Criteria:\n\nPresence of objective tinnitus\n\nHistory of neurological disorders\n\nDiagnosed major psychiatric disorders\n\nReceipt of tinnitus-related treatment within the previous 3 months\n\nInability to use or access the smartphone application (for technical or device-related reasons)'}, 'identificationModule': {'nctId': 'NCT07324603', 'briefTitle': 'Smartphone-Based vs Face-to-Face Counseling for Tinnitus', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'A Randomized Controlled Trial Comparing Smartphone-Based and Face-to-Face Counseling for Chronic Tinnitus', 'orgStudyIdInfo': {'id': 'İ04-201-23'}, 'secondaryIdInfos': [{'id': '124S118', 'type': 'OTHER_GRANT', 'domain': 'TUBITAK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Face-to-Face Counseling', 'description': 'Participants receive structured tinnitus counseling delivered in person using a standardized educational booklet over a six-week period.', 'interventionNames': ['Behavioral: Face-to-Face Tinnitus Counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Smartphone-Based Counseling', 'description': 'Participants receive the same structured tinnitus counseling delivered via a mobile application with sequential modules over a six-week period.', 'interventionNames': ['Behavioral: Smartphone-Based Tinnitus Counseling']}], 'interventions': [{'name': 'Face-to-Face Tinnitus Counseling', 'type': 'BEHAVIORAL', 'description': 'Structured tinnitus counseling is delivered in person using a standardized educational booklet over a six-week period.', 'armGroupLabels': ['Face-to-Face Counseling']}, {'name': 'Smartphone-Based Tinnitus Counseling', 'type': 'BEHAVIORAL', 'description': 'Structured tinnitus counseling is delivered via a mobile application with sequential modules over a six-week period', 'armGroupLabels': ['Smartphone-Based Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Kayseri', 'state': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University Faculty of Health Sciences', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Scientific and Technological Research Council of Turkey', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Beyza ASTA', 'investigatorAffiliation': 'TC Erciyes University'}}}}