Randomized controlled trial of a smartphone-based cognitive behavioral therapy for chronic tinnitus

PLOS Digit Health. 2023 Sep 7;2(9):e0000337. doi: 10.1371/journal.pdig.0000337. eCollection 2023 Sep.

Abstract

Tinnitus, the phantom perception of sounds, generates distress and anxiety in those affected. Cognitive behavioral treatment approaches reproducibly help patients in managing chronic tinnitus. This study systematically evaluated the usefulness of a tinnitus app (with areas of attention and relaxation, mindfulness, acceptance, self-efficacy), which is prescribed for a total of nine months. One hundred eighty-seven participants with chronic tinnitus were equally randomized to an intervention arm that used a smartphone-based intervention -marketed as Kalmeda Tinnitus app-. and a control arm with delayed onset of treatment by 3 months. The first 3 months of a 9-months prescribed intervention have been analyzed as primary outcome. The Tinnitus Questionnaire (TQ) was used as primary endpoint to determine the reduction of tinnitus distress. Following intervention, there was a statistically significant and clinically relevant reduction of the TQ sum score in the intervention group compared to the control group (p<0.001, Cohen's d effect size = 1.1). The secondary parameters, Patient Health Questionnaire-9 (PHQ9) and Perceived-Stress-Questionnaire (PSQ20) scores improved significantly in the intervention group whereas the Self Efficacy-Optimism-Pessimism short form (SWOP-K9) scores remained unchanged in both groups. Patients reported no treatment-related side effects. Taken together, use of this Tinnitus app lead to a significant decrease in tinnitus distress and a clinically relevant effect in the patients´ self-reported everyday management.

Grants and funding

The study was funded by mynoise GmbH. The funders participated in study design, decision to publish, and review of the manuscript, they had no role in data collection and analysis. WS is coordinator of EU (Horizon 2020 framework) funded "Unification of Treatments and Interventions for Tinnitus Patients" (UNITI, grant no. 848261; Schlee et al., 2021); TK, CEO of CRO Dr Kottmann received a contractual fee from mynoise for the conduct of the study; WS, UW, LB receive personal fees from G. Pohl-Boskamp GmbH & Co. KG for review of the manuscript and consultancy.