H93.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Chronic subjective tinnitus (minimum duration 3 months) with tinnitus-related distress of at least grade 2 according to the Tinnitus Questionnaire (TQ, Goebel & Hiller) Signed informed consent
Exclusion criteria
Exclusion criteria: Severe hearing loss (> 60 dB) Severe neurological disorders or acute psychiatric disorders preventing participation in group treatment Otological diseases or other rehabilitation therapies that might interfere with study participation Metal implants precluding MEG measurement Use of psychotropic medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in resting-state functional connectivity, measured by magnetoencephalography (MEG), at T1 (first day of treatment) and T2 (approximately 3.5 weeks later, following completion of the five-day treatment and the subsequent hearing aid training phase). | — |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaire assessments were conducted at four time points (Q1, Q2, Q3): Q1/T1 (first day of treatment), T2 (approximately 3.5 weeks after T1), Q2 (3 months after Q1), and Q3 (3 months after Q2). T1/Q1 and T2 (MEG assessment time points): Tinnitus-related distress, Tinnitus Questionnaire (TQ, Goebel & Hiller) (primary measure) State anxiety, State-Trait Anxiety Inventory, State Scale (STAI-S) Current affective state, Positive and Negative Affect Schedule (PANAS) T1/Q1, Q2 and Q3 (questionnaire time points, each 3 months apart): Tinnitus-related distress, Tinnitus Questionnaire (TQ, Goebel & Hiller) Self-efficacy, optimism and pessimism (SWOP) Perceived stress, Perceived Stress Questionnaire (PSQ-20) Depressive symptoms, Center for Epidemiologic Studies Depression Scale (CES-D) Current mood state, Mood Adjective Checklist (BSF) Physical complaints, Berlin Complaint Inventory (BI) Pain sensitivity, Pain Sensitivity Questionnaire (SES – Schmerzempfindungsskala) ICD-10-based symptom severity, ICD-10 Symptom Rating (ISR) T1/Q1 and Q3 (supplementary tinnitus outcome measures): Tinnitus Handicap Questionnaire (THQ) Tinnitus Handicap Inventory (THI) Tinnitus Functional Index, Version 2 (TFI-2) Baseline (T1/Q1 only): Demographic and socioeconomic information (SOZ-K) Depressive symptoms, Beck Depression Inventory (BDI) Trait anxiety, State-Trait Anxiety Inventory, Trait Scale (STAI-T) Intolerance of uncertainty, Intolerance of Uncertainty Scale (UI-18) Patient Health Questionnaire (PHQ-D) (All questionnaires were administered in their German versions.) | — |
Countries
Germany
Contacts
Universitätsklinikum Jena