RP311 - Development and Testing of a Prototype Digital Tinnitus Polytherapeutic

Abstract:
We describe the development and single-blind randomized controlled trial of a prototype digital therapeutic (DTx) designed to provide goal-based counselling with personalized passive and active game-based sound therapy over a 12 week period. Mean changes in TFI for the test DTx group at 6 (16.36, SD 17.96) and 12 weeks (N= 31, 17.83 points, SD 19.87) were clinically meaningful ( >13 points reduction), the mean changes in a control group with sound app were not clinically meaningful (6 weeks N=30, 10.77, SD 18.53; 12 weeks 10.12 points, SD 21.36). The DTx demonstrated significant benefit for tinnitus reduction supporting further development.

Summary:
Rationale
Tinnitus is a very heterogenous disorder with no pharmaceutical cure. Cognitive behavioral therapy, counselling and sound-based therapies help some sufferers, some of the time. Our research group has been developing tools for goal oriented therapy for 20 years and the concepts have matured sufficiently to assemble as an omnibus therapy. This presentation will describe the development of the therapy before focusing on the outcomes of a randomized single-blind controlled trial that tested the hypothesis that a novel prototype digital therapeutic (DTx) developed to provide goal-based counselling with personalized passive and active game-based sound therapy would provide superior tinnitus outcomes, and similar usability, to a popular passive sound therapy app over a trial period of 12 weeks.

Methods: The DTx consisted of a smartphone app for iPhone or Android, Bluetooth bone conduction headphones and neck pillow speaker with a cloud-based clinician dashboard that enabled text-based messaging and app personalization. The control app was a popular self-help passive sound therapy app: White Noise Lite (WN) with headphones. Behavioral measures of tinnitus were recorded at screening (3-4 weeks before intervention) on the day of intervention, 6 and 12 weeks after commencing the intervention. The primary outcome measure was clinically meaningful change in Tinnitus Functional Index (TFI) between baseline and 12 weeks of therapy. Secondary tinnitus measures were the TFI total score, TFI subscales across sessions, Client Oriented Scale of Improvement in Tinnitus (COSIT) and numeric rating scales (0-10 rating, 0 not a problem – 10 extreme problem). The usability of the US and WN interventions were assessed using the System Usability Scale (SUS) and the mHealth App Usability Questionnaire (MAUQ). Ninety-eight participants who were smartphone app users and had chronic moderate-severe tinnitus ( >6 months, TFI score > 40) were enrolled and were randomly allocated to the intervention groups. Thirty-one participants in the DTx group and 30 in the WN group completed 12 weeks of trial per protocol.

Results
Mean changes in TFI for the USL group at 6 (16.36, SD 17.96) and 12 weeks (17.83 points, SD 19.87) were clinically meaningful ( >13 points reduction), the mean change in WN scores were not clinically meaningful (6 weeks 10.77, SD 18.53; 12 weeks 10.12 points, SD 21.36). A statistically higher proportion of participants in the DTx group achieved meaningful TFI change at 6 weeks (55%) and 12 weeks (65%) than the WN group at 6 weeks (33%) and 12 weeks (43%). Mean TFI, rating and COSIT scores favored the DTx but were not statistically different from WN. Usability measures were similar for both groups.

Conclusions
The DTx group demonstrated a higher proportion of responders than the WN group. The usability of the DTx was similar to the established WN app. The DTx demonstrated significant benefit for tinnitus reduction supporting further development. The intervention tested in this research is a step towards an effective digital polytherapeutic that can accommodate individual goals and predictors of therapy success by employing multiple strategies to modify the neural networks underpinning tinnitus perception and distress.