| Summary: | Tinnitus, the phantom perception of sounds, generates distress and anxiety in those affected. Cognitive behavioral treatment approaches reproducibly help patients in managing chronic tinnitus. This study systematically evaluated the usefulness of a tinnitus app (with areas of attention and relaxation, mindfulness, acceptance, self-efficacy), which is prescribed for a total of nine months. One hundred eighty-seven participants with chronic tinnitus were equally randomized to an intervention arm that used a smartphone-based intervention -marketed as Kalmeda Tinnitus app-. and a control arm with delayed onset of treatment by 3 months. The first 3 months of a 9-months prescribed intervention have been analyzed as primary outcome. The Tinnitus Questionnaire (TQ) was used as primary endpoint to determine the reduction of tinnitus distress. Following intervention, there was a statistically significant and clinically relevant reduction of the TQ sum score in the intervention group compared to the control group (p<0.001, Cohen's d effect size = 1.1). The secondary parameters, Patient Health Questionnaire-9 (PHQ9) and Perceived-Stress-Questionnaire (PSQ20) scores improved significantly in the intervention group whereas the Self Efficacy-Optimism-Pessimism short form (SWOP-K9) scores remained unchanged in both groups. Patients reported no treatment-related side effects. Taken together, use of this Tinnitus app lead to a significant decrease in tinnitus distress and a clinically relevant effect in the patients´ self-reported everyday management.
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