Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT04310605
Status:
COMPLETED
Last Update Posted:
2020-03-17
First Post:
2020-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Specialised Cognitive Behavioural Therapy (CBT) for Tinnitus.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 403}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2016-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-13', 'studyFirstSubmitDate': '2020-03-13', 'studyFirstSubmitQcDate': '2020-03-13', 'lastUpdatePostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health Utilities Index-III', 'timeFrame': '12 months', 'description': 'The Health Utilities Index (HUI; Feeny et al., 2002; Horsman, Furlong, Feeny, \\& Torrance, 2003) is a 17-item measure designed to assess health related quality of life.'}], 'secondaryOutcomes': [{'measure': 'Tinnitus Handicap Inventory (THI)', 'timeFrame': '12 months', 'description': 'The THI (Newman, Jacobson, \\& Spitzer, 1996; Newman, Sandridge, \\& Jacobson, 1998).is a 25 items measure of the impact of tinnitus on daily life that includes three subscales. The subscales cover functional (mental, social/occupational and physical functioning), emotional impact and catastrophic responses to tinnitus.'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983).', 'timeFrame': '12 months', 'description': 'The HADS is a widely used measure of psychological distress in people experiencing a concurrent physical health condition. It has 14 items and respondents use a Likert-type scale to indicate how often they have had a particular feeling in the previous week (e.g. "I feel tense or wound up").'}, {'measure': 'Tinnitus Catastrophizing Scale (TCS)', 'timeFrame': '12 months', 'description': "Tinnitus Catastrophizing Scale (TCS; Cima, Crombez, \\& Vlaeyen, 2011). The TCS was used to assess the degree to which people thought or expected the worst about tinnitus (i.e. catastrophizing). The TCS is a 13-item measure based on the Pain Catastrophizing Scale (Sullivan, Bishop, \\& Pivik, 1995) and respondents use a five point scale to indicate the degree to which statements applies to them (e.g. It's terrible and I think it's never going to get any better). The total score on the TCS ranges from 0 to 65."}, {'measure': 'Fear of Tinnitus Questionnaire (FTQ)', 'timeFrame': '12 months', 'description': 'The FTQ is a 17-item self-report measure intended and designed to assess respondents\' level of fear regarding their tinnitus. Items in the questionnaire are presented as a series of statements (e.g. "I am afraid that my tinnitus will become worse") from which respondents are asked to indicate if it is applicable to their current situation. Each statement receives a score of 1 when applicable. The total score is the sum of all applicable statements and provides an overall rating of fear of tinnitus and ranges from 0 to 17.'}, {'measure': 'Tinnitus Questionnaire (TQ)', 'timeFrame': '12 months', 'description': 'The Tinnitus Questionnaire (TQ; Hallam, Jakes, \\& Hinchcliffe, 1988) is a self-report questionnaire designed to asses distress and interference in daily activities that is associated with tinnitus. It has 52 items and uses a three-point scale to indicate levels of distress on six subscales. The total possible score on the TQ ranges from 0-84.'}, {'measure': 'Tinnitus Disability Index (TDI)', 'timeFrame': '12 months', 'description': 'The Tinnitus Disability Index (TDI; Cima, Vlaeyen, Maes, Joore, \\& Anteunis, 2011) is a seven-item self-report questionnaire that assesses the level of interferences in daily activities (such as occupational, social, and recreational) attributed to tinnitus. Respondents use an 11-point scale to indicate the level of interference ranging from 0 no disability, to 10 total disability. The total score ranges from 0 to 70 with higher scores indicating higher levels of interference.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tinnitus', 'CBT', 'cognitive behaviour therapy'], 'conditions': ['Tinnitus, Subjective']}, 'referencesModule': {'references': [{'pmid': '22633033', 'type': 'BACKGROUND', 'citation': 'Cima RF, Maes IH, Joore MA, Scheyen DJ, El Refaie A, Baguley DM, Anteunis LJ, van Breukelen GJ, Vlaeyen JW. Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial. Lancet. 2012 May 26;379(9830):1951-9. doi: 10.1016/S0140-6736(12)60469-3.'}]}, 'descriptionModule': {'briefSummary': 'This is an observational study of specialised CBT for tinnitus for adults delivered in routine care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with tinnitus', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tinnitus is the primary complaint and reason for seeking help\n* Participant is at least 17 years of age,\n\nExclusion Criteria:\n\n* Unable to read and write in Dutch\n* Tinnitus is not the primary complaint\n* Person is under 17 years of age\n* Participant has a health condition that prevents them from attending treatment centre\n* An Ear Nose Throat (ENT) physician assesses the participant as having ontological condition that requires medical treatment'}, 'identificationModule': {'nctId': 'NCT04310605', 'briefTitle': 'Effectiveness of Specialised Cognitive Behavioural Therapy (CBT) for Tinnitus.', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University'}, 'officialTitle': 'Cognitive Behaviour Therapy (CBT) for Tinnitus Treatment: Implementation and Validity', 'orgStudyIdInfo': {'id': 'ECP-152 05_12_2014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Step 1 only', 'description': 'Participants in the study who only receive Step 1 of specialised CBT', 'interventionNames': ['Behavioral: CBT 1']}, {'label': 'Step 1 and 2', 'description': 'Participants who receive both Step 1 and Step 2 of speciliased CBT for tinnitus.', 'interventionNames': ['Behavioral: CBT 1', 'Behavioral: CBT 2']}], 'interventions': [{'name': 'CBT 1', 'type': 'BEHAVIORAL', 'description': 'CBT for tinnitus (Step 1) comprised: individual audiometric assessment, and counselling about hearing and tinnitus (1hr) with an audiologist; a one-off educational group session (a max 10 participants and partners) (2hrs); an assessment session with a psychologists (1 hr).', 'armGroupLabels': ['Step 1 and 2', 'Step 1 only']}, {'name': 'CBT 2', 'type': 'BEHAVIORAL', 'description': 'Step 2 group sessions were 2 hrs long over a 12-week period. Two therapists (a psychologist and physiotherapist) were present at any one time for Step 2 sessions. Step 2 included: psycho-education; exposure therapy; mindfulness exercises; cognitive restructuring; attention redirecting techniques; stress reduction; and, relaxation techniques. Evening sessions were also provided for participants to attend with family or partners.', 'armGroupLabels': ['Step 1 and 2']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University', 'class': 'OTHER'}, 'collaborators': [{'name': 'SWOL Limburgs Fonds voor Revalidatie', 'class': 'UNKNOWN'}, {'name': 'Flemish Government, Belgium', 'class': 'UNKNOWN'}, {'name': 'The Netherlands Organization for Scientific Research (NWO)', 'class': 'UNKNOWN'}, {'name': 'Libra Revalidatie en Audiologie', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}