Continuous improvement of chronic tinnitus by a 9 months smartphone-based cognitive behavioral therapy: randomized controlled trial (Preprint)

BACKGROUND Tinnitus is the perception of sound without an external auditive stimulus and can be a severe burden for affected patients. Cognitive Behavioral Therapy (CBT) is recommended by medical guidelines and effectively improves tinnitus related distress and anxiety. OBJECTIVE The study investigated the outcome of a 9 months smartphone-based CBT in patients suffering from tinnitus. METHODS The present randomized controlled clinical trial investigated the efficacy of a smartphone-based CBT in 187 patients suffering from chronic tinnitus over a 9-months treatment period. In the initial 3 months a waiting-list design was applied and in the subsequent study phase data of both treatment groups were collectively analyzed. Tinnitus Questionnaire (TQ), Patients Health Questionnaire (PHQ9), Self-Efficacy-Optimism-Pessimism (SWOP-K9), and Perceived-Stress-Questionnaire (PSQ20) were assessed as endpoints after 3 and 9 months of treatment. RESULTS Following the app-based CBT, the TQ sum scores were significantly reduced, indicating a significant decrease of tinnitus-related distress. The calculated Cohen’s d was 1.38 and the observed improvement also exceeded the minimal clinically important difference. Similarly, all other parameters PSQ20 (-9.14 points), PHQ9 (-2.47 points) and SWOP-K9 (0.17 points) were significantly improved at the end of therapy with corresponding intermediate effect sizes after 9 months. The study revealed a significant reduction of tinnitus burden in patients who received a smartphone-based CBT. TQ was reduced by 12.49 ± 1.44 and 18.48 ± 1.85 points after 3 and 9 months, respectively, whereby the improvement was clinically important. CONCLUSIONS The data provide evidence of a substantial and continuous benefit of CBT in patients suffering from chronic tinnitus. CLINICALTRIAL DRKS-ID: DRKS00022973