H93.1
Conditions
Interventions
Group 1: Treatment group: 9-week app-based training programme (Milou), three exercises every day to build neck and shoulder muscles, use the app from T1 to T2, become control group from T2 to T3
Group
Sponsors
Universitätsklinikum Regensburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Chronic tinnitus (duration = 6 months) - Score of = 18 in the Tinnitus Handicap Inventory, i.e. at least mild tinnitus distress - Somatic tinnitus diagnosed by the Somatic Tinnitus Questionnaire - Short Version (STQ-Short) - Fluent English skills - Owner of a smartphone with iOS or Android operating system - Ability to understand the research and willingness to use the ‘Milou’ mobile application on their smartphone
Exclusion criteria
Exclusion criteria: - Diseases of the ear (e.g. otosclerosis, acoustic neuroma, Meniere’s disease) - Start of any other tinnitus related treatments, especially structured counselling, sound therapy or cognitive behavioural therapy in the past 3 months before the start of the study - Missing written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tinnitus distress measured with the Tinnitus Handicap Inventory (THI) at the time points -T1, T1, T2 and T3 | — |
Secondary
| Measure | Time frame |
|---|---|
| The following questionnaires are also collected: - Diagnostic criteria for somatic tinnitus with the Somatic Tinnitus Questionnaire - Short Version (STQ-Short) at the time point -T1 - Demographic data and clinical characteristics of the tinnitus with the European School for Interdisciplinary Tinnitus Research Screening Questionnaire (ESIT-SQ) at the time point -T1 - Tinnitus-related psychological distress with the Mini Tinnitus Questionnaire-12 (Mini TQ-12) at the time points T1, T2, T3 - Self-reported change with the Clinical Global Impression (CGI) at the time points T2/T3 after the end of the intervention - BIG-5 personality traits with the questionnaire Big Five Inventory-2 (BFI-2) at the time point -T1 - App quality with the questionnaire App Quality Assessment Tool for Health-Related Apps (AQUA) at the time points T2/T3 after the end of the intervention - The burden of quarantine with the questionnaire Social Isolation Electronic Survey (SOISES) at the time points T2/T3 after the end of the intervention The ‘Milou’ app conducts daily evaluations of the health status of patients by offering four different questions over a period of 9 weeks. The questions measure levels of (1) loudness of the tinnitus, (2) tinnitus-related distress, (3) flexibility of the neck and (4) subjective difficulty of the exercises. All four questions are presented on a 11-point (0 to 10) Likert scale. | — |
Countries
Germany
Contacts
Public ContactStella Wölflick
Lehrstuhl für Psychiatrie und Psychotherapie
Outcome results
None listed