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

Milena Engelke; Jorge Simões; Carsten Vogel; Stefan Schoisswohl; Martin Schecklmann; Stella Wölflick; Rüdiger Pryss; Thomas Probst; Berthold Langguth; Winfried Schlee

doi:10.1371/journal.pdig.0000183

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

PLOS Digit Health. 2023 Jan 18;2(1):e0000183. doi: 10.1371/journal.pdig.0000183. eCollection 2023 Jan.

Authors

Affiliations

¹ Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.
² Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany.
³ Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Krems, Austria.
⁴ Institute for Information and Process Management, Eastern Switzerland University of Applied Sciences, St. Gallen, Switzerland.

Abstract

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.

Copyright: © 2023 Engelke et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Grants and funding

This project has received funding from the European Union's Horizon 2020 Research and Innovation Programme, Grant Agreement Number 848261 (ME, JS, CV, SS, MS, SW, RP, BL, WS). TP didn’t receive any funding. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.