Smartphone-Based Cognitive Behavioral Therapy and Customized Sound Therapy for Tinnitus: A Randomized Controlled Trial

Objective: To evaluate the efficacy of a smartphone-based application providing tinnitus-specific cognitive behavioral therapy and customized sound therapy for tinnitus. Methods: In a prospective randomized controlled trial, the treatment group participated in daily sound therapy and weekly interactive CBT modules, and the control group did not receive the program (waitlisted). Outcome measures after 8 weeks included the Tinnitus Functional Index (TFI), Generalized Anxiety Disorder (GAD-7), Patient Health Questionnaire (PHQ-9), Perceived Stress Scale (PSS), and Pittsburgh Sleep Quality Index (PSQI). Results: Ninety-two patients (mean age = 57.2 ± 11.9 years) were included. The treatment (n = 47) and control (n = 45) cohorts had similar TFI, PHQ-9, GAD-7, PSS, and PSQI scores at presentation (all P > .05). Treatment-group patients had significantly higher improvements than controlled patients in their TFI (16.7 ± 14.9 vs 1.9 ± 10.8, P < .001), PHQ-9 (1.9 ± 4.2 vs −0.7 ± 3.4, P = .002), GAD-7 (1.1 ± 3.6 vs −0.9 ± 3.3, P = .009), and PSQI scores (2.5 ± 3.2 vs −1.1 ± 2.1, P < .001). Treatment-group subjects also significantly improved in 7 of the 8 TFI domains (all P < .05). TFI improvements of ≥20 occurred in 18 (38.3%) treatment subjects. Of the 9 treatment-group patients presenting with moderate-severe depression, 4 (44.4%) improved to minimal depression. Of the 4 treatment-group patients with moderate-severe anxiety, 2 (50.0%) improved to minimal anxiety. Of the 17 treatment-group patients with moderate-severe sleep difficulties, 10 (55.6%) had considerable sleep improvement. Conclusion: This novel smartphone application providing cognitive behavioral therapy and customized sound therapy was effective in reducing symptom severity and improving anxiety, sleep, and mood for tinnitus patients.