To evaluate the efficacy of a smartphone-based cognitive behavioral therapy (CBT) app for managing chronic tinnitus in Japanese-speaking individuals.
Approach:
Study Design: A double-blind, sham-control, parallel-group comparative randomized clinical trial (RCT) conducted at three medical institutes in Japan.
Participants: Patients aged 18 to 75 years with mild to severe chronic tinnitus were enrolled, meeting specific inclusion criteria.
Intervention: Participants were assigned to either an active app delivering therapeutic content or a sham-control app lacking therapeutic content.
Assessment: Participants were evaluated at baseline and at weeks 4, 8, 12, 16, and 24 using the Tinnitus Handicap Inventory (THI) score.
Key Findings:
The active app included components such as disease education, relaxation exercises, cognitive training, and behavioral activation, which were designed to facilitate long-term habituation and symptom management for tinnitus.
Interpretation:
Digital therapeutics may provide an effective means to expand access to evidence-based tinnitus care, particularly in regions with limited availability of traditional CBT.
Limitations:
The study's sample size was limited to 60 participants, which may affect the generalizability of the findings.
The trial was conducted in a specific geographic region (Japan), which may limit applicability to other populations.
Conclusion:
The study presents findings on the use of a digital therapeutic app for managing chronic tinnitus, highlighting the need for accessible treatment options.