Pilot study of a smartphone-based tinnitus therapy using structured counseling and sound therapy: A multiple-baseline design with ecological momentary assessment

Tinnitus affects a considerable part of the population and develops into a severe disorder in some sufferers. App-based interventions are able to provide low-threshold, cost-effective, and location-independent care for tinnitus patients. Therefore, we developed a smartphone app combining structured counseling with sound therapy and conducted a pilot study to evaluate treatment compliance and symptom improvement (trial registration: DRKS00030007). Outcome variables were Ecological Momentary Assessment (EMA) measured tinnitus distress and loudness and Tinnitus Handicap Inventory (THI) at baseline and final visit. A multiple-baseline design with a baseline phase (only EMA) followed by an intervention phase (EMA and intervention) was applied. 21 patients with chronic tinnitus (≥ 6 months) were included. Overall compliance differed between modules (EMA usage: 79% of days, structured counseling: 72%, sound therapy: 32%). The THI score improved from baseline to final visit indicating a large effect (Cohens d = 1.1). Tinnitus distress and loudness did not improve significantly from baseline phase to the end of intervention phase. However, 5 of 14 (36%) improved clinically meaningful in tinnitus distress (ΔDistress ≥ 10) and 13 of 18 (72%) in THI score (ΔTHI ≥ 7). The positive relationship between tinnitus distress and loudness weakened over the course of the study. A trend but no level effect for tinnitus distress could be demonstrated by a mixed effect model. The improvement in THI was strongly associated with the improvement scores in EMA of tinnitus distress (r = -0.75; 0.86). These results indicate that app-based structured counseling combined with sound therapy is feasible, has an impact on tinnitus symptoms and reduces distress for several patients. In addition, our data suggest that EMA could be used as a measurement tool to detect changes in tinnitus symptoms in clinical trials as has already been shown in other areas of mental health research. Author summary Tinnitus is the perception of a phantom sound which is generated in the brain. Many people are affected by tinnitus and some suffer severely. Management strategies can effectively reduce suffering of some patients. However, the access towards these treatments is limited due to long distances and lack of trained therapists. Therefore, there is increasing interest whether tinnitus management can be delivered via smartphone. In this study, we evaluated a smartphone application consisting of educational counseling and sound therapy with respect to treatment compliance and symptom improvement. We measured tinnitus symptoms at the beginning of baseline and at the end of intervention using clinical questionnaires, but also during the course of treatment using daily questions which were integrated in the mobile application. The app was used regularly by the patients (sound therapy: 32% of days, structured counseling: 72% of days; tinnitus assessment: 79% of days). Tinnitus handicap improved clinically meaningful for 13 of 18 patients, tinnitus distress for 5 of 14 and tinnitus loudness for 2 of 14. The correlation between tinnitus distress and loudness weakened during the study course. Thus, this study indicates that app-based tinnitus management has an impact on tinnitus symptoms and reduces suffering for several patients