Digital Tinnitus Counseling in Clinical Practice: A Multicenter Randomized Controlled Trial

Area of Science:

• Otolaryngology and Digital Health
• Clinical Psychology and Behavioral Medicine

Background:

• Subjective tinnitus is a prevalent and often debilitating condition.
• Current management guidelines emphasize counseling interventions due to the lack of effective pharmacotherapy.
• Digital health solutions offer a scalable approach to delivering guideline-compliant counseling.

Purpose of the Study:

• To evaluate the efficacy of guideline-compliant counseling delivered via the smartphone application 'Meine Tinnitus App'.
• To assess the impact of digital counseling on tinnitus-related distress and daily burden.
• To compare outcomes between an intervention group receiving digital counseling plus standard care and a control group receiving standard care only.

Main Methods:

• A randomized controlled trial involving 204 patients with chronic subjective tinnitus across 33 ENT practices in Germany.
• Intervention group received 10 weeks of digital counseling via 'Meine Tinnitus App' alongside standard care.
• Primary endpoint: change in tinnitus-related distress (Mini-TQ-12). Secondary endpoint: change in daily burden and coping difficulties (BVB-2000).

Main Results:

• The intervention group demonstrated significant reductions in tinnitus-related distress (EMM [95% CI]: 4.5 [3.3-5.8]) and improvements in daily burden (EMM [95% CI]: 0.5 [0.2-0.7]).
• Effect sizes were large to moderate (Hedges' g between 1.1 and 0.5), with results confirmed by responder and sensitivity analyses.
• Higher app usage was associated with greater improvements in both primary and secondary endpoints (p < 0.05).

Conclusions:

• The 'Meine Tinnitus App' effectively alleviates tinnitus-related distress, daily burden, and coping difficulties in patients with subjective tinnitus.
• Digital counseling represents a viable and effective therapeutic option for managing subjective tinnitus.
• The study supports the health benefits of digital counseling interventions for tinnitus management.