Abstract
Object
Acute tinnitus (AT), defined as tinnitus present for less than three months, is frequently managed in clinical practice with a focus on auditory recovery (e.g., corticosteroids or hyperbaric oxygen therapy), while early psychological burden remains largely unaddressed. Although psychoeducational and cognitive-behavioral interventions are well established for chronic tinnitus, prompt structured support in the acute phase is not yet standard care. Untreated distress during the early phase may increase the risk of persistent tinnitus-related anxiety, depression, sleep disturbance, and reduced quality of life, with substantial socio-economic consequences.
The RAPID-TREAT project aims to evaluate whether a prompt, web-based psychoeducational intervention can reduce tinnitus burden in patients with AT. The primary objective is to compare the effectiveness of the acute e-learning program with standard clinical care in reducing tinnitus distress, measured by the Tinnitus Functional Index (TFI) at 12–16 weeks.
Method
This study is designed as a single-blind, two-arm, 1:1 randomized controlled trial following CONSORT and TiDieR recommendations. Adult patients (≥18 years) presenting with acute tinnitus (<3 months duration) will be eligible. A total of 146 participants (73 per group), accounting for 20% dropout, will be recruited based on power calculations to detect a clinically meaningful 13-point between-group difference in TFI score.
All participants receive standard ENT assessment, including pure-tone audiometry (up to 16 kHz), speech-in-noise testing, and medical treatment where indicated. Participants are randomized (minimization by gender and baseline TFI grade) to either:
1. Standard clinical care (control), or
2. Standard care plus a 10-day web-based psychoeducational program (15 minutes/day), addressing stress, sleep, concentration, coping strategies, and relaxation techniques.
The primary outcome is change in TFI from baseline to 12–16 weeks. Secondary objectives include identifying psychological, demographic, and audiological predictors of tinnitus burden, assessing system usability, and determining the cost-effectiveness of the intervention from a societal perspective.
Discussion
Current tinnitus management predominantly targets chronic cases, leaving a critical therapeutic window in the acute phase insufficiently addressed. The intervention aligns with contemporary digital health strategies and value-based healthcare principles by aiming to reduce long-term psychological morbidity and associated costs. By embedding economic evaluation within the RCT, the project integrates clinical effectiveness with cost-utility analysis, enabling robust policy-relevant conclusions. The societal perspective, including productivity losses, is particularly relevant given the known economic burden of tinnitus.
Conclusion
RAPID-TREAT is the first randomized controlled trial to evaluate a prompt, web-based psychoeducational intervention specifically targeting acute tinnitus. By intervening during the pre-chronic phase, the study aims to prevent long-term tinnitus-related psychological distress and reduce the need for intensive chronic care. The integration of clinical, psychological, and economic outcomes provides a comprehensive evaluation of both effectiveness and value. If the intervention proves clinically beneficial and cost-effective, it may support implementation of early digital psychoeducational pathways as part of routine acute tinnitus management. Ultimately, this project has the potential to shift tinnitus care from reactive chronic treatment toward proactive early intervention, improving patient quality of life while optimizing healthcare resource allocation.
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