%0 Journal Article
%@ 1438-8871
%I JMIR Publications
%V 27
%N
%P e59575
%T Continuous Improvement of Chronic Tinnitus Through a 9-Month Smartphone-Based Cognitive Behavioral Therapy: Randomized Controlled Trial
%A Walter,Uso
%A Pennig,Stefan
%A Bleckmann,Lothar
%A Röschmann-Doose,Kristina
%A Wittig,Thomas
%A Thomsen,Jörn
%A Schlee,Winfried
%+ G Pohl-Boskamp GmbH & Co KG, Kieler Straße 11, Hohenlockstedt, 25551, Germany, 49 4826 59 457, j.thomsen@pohl-boskamp.de
%K tinnitus
%K chronic tinnitus
%K mobile health app
%K mHealth
%K mobile app
%K application
%K smartphone
%K digital health
%K digital technology
%K digital intervention
%K cognitive behavioral therapy
%K randomized controlled trial
%K statistical analysis
%D 2025
%7 18.2.2025
%9 Original Paper
%J J Med Internet Res
%G English
%X Background: Tinnitus is the perception of sound without an external auditive stimulus and can be a severe burden for affected patients. Medical guidelines recommend cognitive behavioral therapy (CBT) for tinnitus treatment, which effectively improves tinnitus-related distress and anxiety. Objective: This study investigates the outcome of a 9-month smartphone-based CBT for patients with tinnitus. Methods: The randomized controlled clinical trial in this study investigates the efficacy of a smartphone-based CBT for 187 patients with chronic tinnitus over a 9-month treatment period. In the initial 3 months, a waiting list design was applied, and in the subsequent study phase, the data of both treatment groups were collectively analyzed. The scores on the Tinnitus Questionnaire (TQ); 9-item Patient Health Questionnaire (PHQ-9); 9-item Self-Efficacy, Optimism, Pessimism (SWOP-K9) questionnaire; and 20-item Perceived Stress Questionnaire (PSQ-20) were assessed as endpoints after 3 and 9 months of treatment. Results: We observed a statistically significant reduction in the tinnitus burden in patients who received the smartphone-based CBT intervention. Although no changes were observed initially in the TQ sum scores in the waiting control group (baseline mean, 37.8, SD 4.7; 3 months mean 37.5, SD 4.8; analysis of covariance [ANCOVA] P=.52), the scores significantly decreased once the app-based CBT had commenced. Data pooled from both groups revealed significant reduction in the TQ sum score by 12.49 (SD 1.44) (ANCOVA, P<.001) and 18.48 (SD 1.85) (ANCOVA, P<.001) points after 3 and 9 months, respectively, which was also clinically important. The calculated Cohen d was 1.38. Similarly, the scores on PSQ-20 (–9.14 points; ANCOVA, P<.001), PHQ-9 (–2.47 points; ANCOVA, P<.001), and SWOP-K9 (0.17 points; ANCOVA, P<.001) were significantly improved at the end of the therapy, with corresponding intermediate effect sizes after 9 months. Conclusions: The data in our study provide evidence of statistically significant, clinically relevant, and continuous benefits of an app-based CBT intervention in patients with chronic tinnitus. Trial Registration: Deutsches Register Klinischer Studien DRKS00022973; https://drks.de/search/de/trial/DRKS00022973
%R 10.2196/59575
%U https://www.jmir.org/2025/1/e59575
%U https://doi.org/10.2196/59575
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