Walter Uso, Pennig Stefan, Kottmann Tanja, Bleckmann Lothar, Röschmann-Doose Kristina, Schlee Winfried
ENT Practice Walter & Zander, Duisburg and mynoise GmbH, Duisburg, Germany.
context, Essen-Kettwig, Germany.
PLOS Digit Health. 2023 Sep 7;2(9):e0000337. doi: 10.1371/journal.pdig.0000337. eCollection 2023 Sep.
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.
耳鸣，即对声音的虚幻感知，会给患者带来痛苦和焦虑。认知行为治疗方法能持续有效地帮助患者应对慢性耳鸣。本研究系统评估了一款耳鸣应用程序（包含注意力与放松、正念、接纳、自我效能等板块）的效用，该应用程序的使用时长总计为九个月。187名慢性耳鸣患者被平均随机分为两组，一组为干预组，使用一款基于智能手机的干预程序（名为Kalmeda耳鸣应用程序）；另一组为对照组，治疗延迟3个月开始。对规定的9个月干预疗程中的前3个月进行了分析，并将其作为主要观察指标。耳鸣问卷（TQ）被用作主要终点指标，以确定耳鸣痛苦程度的减轻情况。干预后，与对照组相比，干预组的TQ总分在统计学上有显著降低，且具有临床意义（p<0.001，科恩d效应量=1.1）。次要参数方面，干预组的患者健康问卷-9（PHQ9）和感知压力问卷（PSQ20）得分显著改善，而两组的自我效能-乐观-悲观简表（SWOP-K9）得分均未发生变化。患者报告未出现与治疗相关的副作用。综上所述，使用这款耳鸣应用程序可显著减轻耳鸣痛苦，并在患者自我报告的日常管理中产生具有临床意义的效果。
